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Voluntary medical male circumcision (VMMC) is a recommended HIV prevention strategy that few studies have promoted to HIV-negative men in serodiscordant relationships. We conducted a cross-sectional study on uptake and perceptions of VMMC among serodiscordant couples between 2012 and 2015. Heterosexual couples attending couples voluntary counselling and testing for HIV who had discordant results (M-, F+) were referred for VMMC. At least one month after counselling and referral, 343 men were surveyed on uptake and perceptions of VMMC. A subset of 134 uncircumcised men responded to another survey assessing their intention to uptake VMMC and reasons for not getting circumcised. Forty percent (n = 62) of men eligible for VMMC either up took (n = 22) or planned to uptake circumcision (n = 40). The most cited reasons for not getting circumcised were the inability to get time off work (34%) and culture/traditions (26%). These findings support integrated approaches, pairing evidence-based HIV prevention interventions such as couples voluntary counselling and testing with VMMC, and targeting men at highest risk for HIV. Additional counselling may be needed for couples whose cultural backgrounds do not support VMMC., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Malama et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Few evidence-based interventions have been widely adopted in common clinical settings, particularly for opioid-dependent people with HIV (PWH) seeking drug treatment. We developed a brief evidence-based intervention, Holistic Health for HIV (3H+), specifically for ease of implementation and integration within drug treatment settings. In this study, we compared 3H+ to the gold standard, Holistic Health Recovery Program (HHRP+) using a non-inferiority trial. Between 2012 and 2017, 106 participants were randomly assigned to either the brief 3H+ intervention or the gold standard HHRP+. HIV treatment (ART adherence, viral suppression) and risk behaviors (sharing injection equipment, condom use) were compared between the two arms at baseline, end-of-intervention (EOI-12 weeks) and at follow-up (24 weeks). Average treatment effect was calculated based on the difference-in-difference (DID) estimator and a non-parametric bootstrap was used to assess non-inferiority. At the 12-week EOI point, 3H+ was found to be non-inferior to HHRP+ with respect to multiple outcomes: percent sharing syringes and needles (DID:1.4, 95%CI [-18.6,21.5], p<0.01) and attainment of high ART adherence (DID: 9.7, 95%CI: [-13.1, 32.2], p = 0.04). At the 24-week EOI point, 3H+ was found to be non-inferior to HHRP+ with respect to percent sharing syringes and needles (DID: 8.9, [-10.1, 28.30], p = 0.04) and attainment of viral suppression (DID: 18.9, 95% CI:[-7.1, 42.0], p = 0.01). For other indicators, such as consistent condom use, the hypothesis test for non-inferiority was inconclusive at the 12-week EOI (DID: -20.2, 95%CI [-48.9-10.7], p = 0.51). For HIV treatment as prevention to be effective, PWH need to achieve viral suppression. In the absence of this success, they must reduce HIV risk behaviors. The finding that 3H+ was non-inferior to HHRP+ suggests that brief behavioral interventions can be deployed in real world settings to help more efficiently achieve Ending the HIV Epidemic goals., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Zelenev et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Current programs to engage marginalized populations such as gay and bisexual individuals and other men who have sex with men (MSM) in HIV prevention interventions do not often reach all MSM who may benefit from them. To reduce the global burden of HIV, far-reaching strategies are needed to engage MSM in HIV prevention and treatment. Globally, including low- and middle-income countries, MSM are now widely using internet-based social and mobile technologies (SMTs; eg, dating apps, social media, and WhatsApp [Meta]), which provides an unprecedented opportunity to engage unreached and underserved groups, such as MSM for HIV prevention and care., Objective: This study aimed to assess the effectiveness of a multilevel mobile health (mHealth)-based intervention to improve HIV testing uptake and status neutral linkage-to-care among sexually active MSM reached through internet-based platforms in Mumbai, India., Methods: In this randomized controlled trial, we will determine whether CHALO! 2.0 (a theory-based multilevel intervention delivered in part through WhatsApp) results in increased HIV testing and linkage-to-care (prevention or treatment). This study is being conducted among 1000 sexually active MSM who are unaware of their HIV status (never tested or tested >6 months ago) and are recruited through SMTs in Mumbai, India. We will conduct a 12-week, 3-arm randomized trial comparing CHALO! 2.0 to 2 control conditions-an attention-matched SMT-based control (also including a digital coupon for free HIV testing) and a digital coupon-only control. The primary outcomes will be HIV testing and status neutral linkage-to-care by 6 months post enrollment. Participants will be followed up for a total of 18 months to evaluate the long-term impact., Results: The study was funded in 2020, with recruitment having started in April 2022 due to delays from the COVID-19 pandemic. Baseline survey data collection began in April 2022, with follow-up surveys starting in July 2022. As of April 2022, we enrolled 1004 participants in the study. The completion of follow-up data collection is expected in January 2025, with results to be published thereafter., Conclusions: While global health agencies have called for internet-based interventions to engage populations vulnerable to HIV who are not being reached, few proven effective and scalable models exist and none is in India, which has one of the world's largest HIV epidemics. This study will address this gap by testing a multicomponent mHealth intervention to reach and engage MSM at high priority for HIV interventions and link them to HIV testing and prevention or treatment., Trial Registration: ClinicalTrials.gov NCT04814654; https://clinicaltrials.gov/study/NCT04814654. Clinical Trial Registry of India CTRI/2021/03/032280., International Registered Report Identifier (irrid): DERR1-10.2196/59873., (©Jatin Chaudary, Shruta Rawat, Alpana Dange, Sarit A Golub, Ryung S Kim, Venkatesan Chakrapani, Kenneth H Mayer, Julia Arnsten, Viraj V Patel. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 05.11.2024.)

Background: Metabolic syndrome (MetS) refers to the clustering of three or more metabolic disorders including high blood pressure, glucose impairment, abdominal obesity, high triglycerides, and low high-density lipoproteins. MetS is increasingly being considered an epidemic among People Living With HIV (PLWH) with reports of association between HIV infection and/or antiretroviral therapy (ART) usage and development of MetS. MetS predisposes PLWH to the development of cardiovascular, kidney diseases and diabetes, decreases the quality of life, and burdens the health system. This study aims to establish the incidence, time to development and risk factors for development of MetS and it's components, and to assess the capacity of the health system to manage MetS and it's components among ART naive PLWH in Accra, Ghana., Methods: We will conduct a mixed methods study with quantitative and qualitative data collection. Our prospective cohort study would enroll adults of 18 years and above with none or less than three MetS components at baseline and follow them up at six months and one year. Demographic, lifestyle data, anthropometric, and laboratory data will be collected using an adapted WHO Steps Survey questionnaire. The WHO Service Availability and Readiness Questionnaire (SARA) will be adapted to collect information on capacity across the six WHO building blocks. Key informant interviews will be conducted with HIV coordinators at the national, regional, and facility levels. In-depth interviews will be conducted with PLWH from the cohort who develop MetS or MetS components during their follow-up. Data will be analysed using proportions, Kaplan Mier time to event analysis, fitting of Cox proportional hazard regression models for risk factors, and generation of themes from qualitative data., Expected Outcome: This study will generate data on the incidence, time to development, risk factors for MetS and MetS components development, and health systems capacity for MetS management among PLWH. Findings would inform revisions to the guidelines and policies for HIV care in Ghana, Africa, and beyond, ultimately improving MetS prevention and management among the vulnerable population of PLWH., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: To monitor the use of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and related medicines for pre-exposure prophylaxis (PrEP) as HIV prevention using commercial pharmacy data, it is necessary to determine whether TDF/FTC prescriptions are used for PrEP or for some other clinical indication., Objective: This study aimed to validate an algorithm to distinguish the use of TDF/FTC for HIV prevention or infectious disease treatment., Methods: An algorithm was developed to identify whether TDF/FTC prescriptions were for PrEP or for other indications from large-scale administrative databases. The algorithm identifies TDF/FTC prescriptions and then excludes patients with International Classification of Diseases (ICD)-9 diagnostic codes, medications, or procedures that suggest indications other than for PrEP (eg, documentation of HIV infection, chronic hepatitis B, or use of TDF/FTC for postexposure prophylaxis). For evaluation, we collected data by clinician assessment of medical records for patients with TDF/FTC prescriptions and compared the assessed indication identified by the clinician review with the assessed indication identified by the algorithm. The algorithm was then applied and evaluated in a large, urban, community-based sexual health clinic., Results: The PrEP algorithm demonstrated high sensitivity and moderate specificity (99.6% and 49.6%) in the electronic medical record database and high sensitivity and specificity (99% and 87%) in data from the urban community health clinic., Conclusions: The PrEP algorithm classified the indication for PrEP in most patients treated with TDF/FTC with sufficient accuracy to be useful for surveillance purposes. The methods described can serve as a basis for developing a robust and evolving case definition for antiretroviral prescriptions for HIV prevention purposes., (©Patrick Sean Sullivan, Robertino M Mera-Giler, Staci Bush, Valentina Shvachko, Eleanor Sarkodie, Daniel O'Farrell, Stephanie Dubose, David Magnuson. Originally published in JMIR Formative Research (https://formative.jmir.org), 04.11.2024.)

Introduction: Opioid overdose deaths in the U.S. have risen dramatically in the past decade, largely due to the surge in illicitly manufactured fentanyl. Injection drug use is a known risk factor for HIV, further complicating the long-term consequences of opioid use. The baseline prevalence of HIV among adults in the US is 0.46 %. The primary purpose of this study was to determine the prevalence and risk factors of HIV among patients presenting to the emergency departments (ED) with an acute opioid overdose., Methods: This study is a prospective observational cohort study from the ToxIC Fentalog Study group. Patients age 18 years of age or older are included if they present to one of 10 participating U.S. hospitals in 9 states between September 2020 and May 2023 with a suspected opioid overdose and had waste serum available after routine laboratory testing. Clinical data is collected from the medical record and patient serum is sent for comprehensive toxicologic analysis via liquid chromatography quadrupole time-of-flight mass spectroscopy to detect the presence of over 1200 substances including illicit opioids, novel synthetic opioids, medications, and adulterants. Logistic multivariable regression was performed to examine the association between demographic, behavioral, and serum toxicology data with risk factors and HIV status., Results: Among the total cohort (n=1690), 1062 cases had known HIV status (62.8 % of total sample). Among patients with a known HIV status, 60 (5.6 % [95 % CI: 4.2 %, 7.0 %]) were HIV positive. Patients with HIV reported stimulant use more frequently (13.3 %) than those without HIV (6.8 %; p=0.003). After controlling for confounding, bipolar psychiatric history was a significant independent predictor of HIV positivity (aOR: 1.08; 95 % CI: 1.02, 1.13) in this population., Conclusions: In this large multicenter cohort, the prevalence of HIV for ED patients with illicit opioid overdose was 9 times higher than that expected by the general population. Bipolar disorder appears to be a novel risk factor for HIV positivity in this patient population., Competing Interests: Declaration of Competing Interest There are no financial, litigational, or other conflicts of interest to disclose., (Copyright © 2024. Published by Elsevier B.V.)

ABSTRACT Many older adults living with HIV face unique challenges, including comorbidities, loneliness, and isolation. This community-academic partnered study elicited viewpoints from older adults living with HIV about the characteristics of a digital environment ("Virtual Village") to combat against loneliness and isolation. We utilized Choice-Based Conjoint Analyses to determine preferred attributes of a Virtual Village. We also conducted focus groups and interviews with older adults living with HIV and used an iterative, data-driven approach to systematically identify emergent themes. Participants ( N  = 82) were aged 50-82 years and racially/ethnically diverse. The majority were men (78%), gay (66%), and lived with HIV for ≥15 years (83%). Cost was the factor that most drove participants' preference for joining a Virtual Village. Thematic concerns included lack of technological confidence, internet access, potential for harassment in digital environments, privacy, and preference for in-person interactions. Praises centered on convenience and making connections across geographic distances. Participants emphasized the need for purposive strategies to form a cohesive and supportive community for older adults living with HIV. A moderated environment was recommneded to create a safe, structured, and comfortable digital environment for older adults living with HIV. A Virtual Village should be viewed as a bridge to in-person interactions.

People living with HIV are disproportionately affected by depression, anxiety, and substance use which impede engagement with HIV treatment services and can increase risks of HIV-related morbidity and mortality. Capturing timely, accurate patient data at point of care is recommended to inform clinical decision-making and retain patients on the HIV care continuum. Currently, there is limited use of validated screening tools for substance use and mental health at the point of care in HIV clinics, even though people with HIV (PWH) have a high prevalence of these comorbidities. Even fewer clinics screen in a manner that encourages disclosure of stigmatized substance use, depression, and anxiety. Electronic patient-reported outcomes (ePROs) are an evidence-based modality to overcome such limitations by eliciting responses directly from patients via tablet, smartphone, or computer. To date, there is limited consensus on how to implement ePROs into non-academic settings and enhance uptake. Our team sought to address this gap by examining the implementation of ePROs, previously implemented in an academic clinic, to enhance screening and treatment of mental health (MH) and substance use at five Ryan White HIV/AIDS Program-funded clinics in Alabama. The ePROs were delivered through a multi-component intervention titled HIV + Service delivery and Telemedicine through Effective Patient Reported Outcomes (+STEP), which also provides targeted training to frontline clinicians, and resources for MH and substance use treatment for PWH without access to care. The objective of this study is to provide an implementation blueprint that can be tested and utilized in other HIV clinics to integrate ePROs and increase evidence-based screening for depression, anxiety, and substance use among PWH, as well as outline lessons learned from implementation to date. The findings from this study provide practical steps and advice based on our experience in implementing electronic patient-reported outcomes in HIV clinics in the US Deep South., Competing Interests: EE reports honorarium from Gilead for participating in the HIV Re-engagement working group and from PRIME, DKBMed, and IAS-USA for developing HIV continuing education content. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Gagnon et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Many cisgender women in the US who have experienced incarceration are at substantial risk for HIV acquisition after they return to the community. Various network interventions have been leveraged for HIV prevention in this population. The objective of this study was to identify network and relationship determinants of influence on HIV prevention decisions, including PrEP., Methods: We conducted interviews with a network mapping exercise with participants recruited from the social and sexual networks of women who had experienced incarceration. Participants enumerated important individuals in their lives from the past six months and provided demographic and relationship data as well as whether each relationship influenced their HIV prevention decisions. We abstracted network data from the interview transcripts and described the data set using descriptive statistics and network density graphs. To measure associations between characteristics at each level and whether a relationship was considered influential regarding PrEP decision-making, we use multiple logistic regression with random intercepts for each respondent., Results: We interviewed 32 participants, average age 33.5 years (SD = 8.98), majority female (n = 28, 87.5%), white (n = 23, 71.8%), heterosexual/straight (n = 25, 78.1%), and with a personal history of incarceration (n = 29, 90%). They reported 253 relationships (119 family, 116 friend, 18 sexual relationships). Most adult network members had used drugs or alcohol (n = 182, 80.9%), and of those, 30.8% had used them with the participant (n = 53). The mean network size was 7 (SD = 4) and network density was 52.2%. In the full model, significant positive predictors of an influential relationship included participant non-heterosexual identity (OR 27.8), older average age in the network (OR 3.9 per standard deviation), and being a current or prior sexual partner (OR 10.1). Significant negative predictors included relationships with individuals who use or had used drugs (OR 0.28), longer average relationship duration in the network (OR 0.09) and being in a network with at least one sexual partner (OR 0.2)., Conclusions: There are significant positive and negative determinants of relationship influence related to PrEP at individual-, dyad-, relationship-, and network-levels. These support using nuanced network approaches to behavior change that respect and leverage the diversity of relationships that comprise the social networks of women who have experienced incarceration., Competing Interests: Dr. Adimora received consulting fees from Merck and Gilead, and UNC received funds from Gilead and Merck for her research. The other authors report no conflicts of interest., (Copyright: © 2024 Knittel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Antibody-dependent cellular phagocytosis (ADCP) has been implicated in protection against HIV-1. However, methods for measuring ADCP currently rely on the phagocytosis of gp120- or gp41-coated beads that do not reflect physiologically relevant conformations of the viral envelope glycoprotein or the size of a virus-infected cell. We therefore developed a novel approach for measuring ADCP of HIV-infected cells expressing natural conformations of Env. A monocytic cell line (THP-1 cells) or primary human monocytes were incubated with a CD4+ T cell line that expresses eGFP upon HIV-1 infection in the presence of antibodies and ADCP was measured as the accumulation of eGFP+ material by flow cytometry. The internalization of HIV-infected cells by monocytes was confirmed visually by image-capture flow cytometry. Cytoskeletal remodeling, pseudopod formation and phagocytosis were also observed by confocal microscopy. We found that potent broadly neutralizing antibodies (bnAbs), but not non-neutralizing antibodies (nnAbs), mediate efficient phagocytosis of cells infected with either primary or lab-adapted HIV-1. A nnAb to a CD4-inducible epitope of gp120 (A32) failed to enable ADCP of HIV-infected cells but mediated efficient phagocytosis of gp120-coated beads. Conversely, a bnAb specific to intact Env trimers (PGT145) mediated potent ADCP of HIV-infected cells but did not facilitate the uptake of gp120-coated beads. These results underscore the importance of measuring ADCP of HIV-infected cells expressing physiologically relevant conformations of Env and show that most antibodies that are capable of binding to Env trimers on virions to neutralize virus infectivity are also capable of binding to Env on the surface of virus-infected cells to mediate ADCP., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Snow et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: We developed the HIV Triplex multiplex bead assay to identify and serotype HIV infection with high sensitivity and specificity; and distinguish recent from long-term HIV-1 infections. It can facilitate accurate incidence estimation, while reducing the number of tests and blood collected, which is highly desirable for use in future studies and surveys. Using previously collected, treatment-naive longitudinal seroconversion HIV-1 positive panels and specimens from individuals infected for >12 months, we determined the assay's mean duration of recent infection (MDRI) and false-recency rate (FRR) respectively, at various mean fluorescent intensity (MFI) cutoffs., Methods: We tested seroconversion specimens (N = 814) from 142 individuals infected with HIV-1 subtypes B, C, or AE, and 1341 cross-sectional specimens from individuals infected >12 months. The MFI cutoffs of 1000 to 2000 were evaluated for recency classification, including an MFI of 1250 corresponding to the limiting antigen avidity enzyme immunoassay (LAg-EIA) cutoff of 1.5 normalized optical density for MDRI and FRR. We used four statistical methods: Methods 1 and 2 used the empirically balanced observation time approach. Method 2 MFI values were raised to power = 1.33, based on a repeated measures model to linearize the relationship between MFI and time points, whereas Method 1 was not linearized. Methods 3 and 4 employed quadratic and linear interpolations for each seroconversion panel. FRR was calculated by dividing the number of specimens misclassified as recent by the total number of specimens tested., Results: MDRI values ranged from 135-146 days at MFI = 1000 to 229-279 days at MFI = 2000 by the 4 methods. FRR varied from 0.15%-1.27% with increasing MFI cutoff. At MFI = 1250, the average MDRI of 4 methods was 169 days and ranged from 159-183 with overlapping 95% CIs and FRR = 0.52%., Conclusion: The HIV Triplex assay demonstrates a longer dynamic range compared to current HIV recency assays with a low FRR for cutoffs examined. With a longer dynamic range and low FRR, the MDRI for recent infection can be extended as appropriate to detect more recent infections, increasing the value of incidence assays benefiting public health surveillance and future surveys., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Introduction: HIV replication leads to a change in lymphocyte phenotypes that impairs immune protection against opportunistic infections. We examined current HIV replication as an independent risk factor for tuberculosis (TB)., Methods: We included people living with HIV from 25 European cohorts 1983-2015. Individuals <16 years or with previous TB were excluded. Person-time was calculated from enrolment (baseline) to the date of TB diagnosis or last follow-up information. We used adjusted Poisson regression and general additive regression models., Results: We included 272,548 people with a median follow-up of 5.9 years (interquartile range [IQR] 2.3-10.9). At baseline, the median CD4 cell count was 355 cells/μL (IQR 193-540) and the median HIV-RNA level 22,000 copies/mL (IQR 1,300-103,000). During 1,923,441 person-years of follow-up, 5,956 (2.2%) people developed TB. Overall, TB incidence was 3.1 per 1,000 person-years (95% confidence interval [CI] 3.02-3.18) and was four times higher in patients with HIV-RNA levels of 10,000 compared with levels <400 copies/mL in any CD4 stratum. CD4 and HIV-RNA time-updated analyses showed that the association between HIV-RNA and TB incidence was independent of CD4. The TB incidence rate ratio for people born in TB-endemic countries compared with those born in Europe was 1.8 (95% CI 1.5-2.2)., Conclusions: Our results indicate that ongoing HIV replication (suboptimal HIV control) is an important risk factor for TB, independent of CD4 count. Those at highest risk of TB are people from TB-endemic countries. Close monitoring and TB preventive therapy for people with suboptimal HIV control is important., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Atkinson et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Adolescent girls and young women (AGYW) in southern Africa face triple the HIV incidence of their male peers due to multiple factors, including economic deprivation and age-disparate relationships. A new study by Aurélia Lépine and colleagues has demonstrated that addressing healthcare costs among AGYW has the potential to reduce HIV incidence., Competing Interests: RVB reports that Regeneron Pharmaceuticals covered the cost of conference abstract and manuscript writing, outside of the submitted work. RVB serves on a Gilead Sciences DMC for which she is paid an honorarium., (Copyright: © 2024 Heitner et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Although long-acting, injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) has proven efficacious for HIV prevention in clinical trials, research is needed to guide effective implementation in real-world settings. Formative work with community members and health care providers (HCPs) is important to provide insight into the needs and contexts of specific populations and reveal potential barriers and facilitators for implementation projects., Objective: We aimed to describe the results from formative work to develop an implementation package for CAB-LA PrEP within the ImPrEP CAB Brasil study., Methods: ImPrEP CAB Brasil is an implementation study of same-day delivery of CAB-LA PrEP for young sexual and gender minority (SGM) groups (aged 18-30 years) in 6 existing oral PrEP public health clinics. We conducted formative research to prepare for the implementation of ImPrEP CAB Brasil through community mobilization, process mapping with HCPs with experience in CAB-LA, and focus group discussions (FGDs) with young SGM groups (n=92) and HCPs (n=20) to identify initial perceptions of facilitators and barriers for CAB-LA PrEP implementation, refine the mobile health (mHealth) educational tool, and evaluate the acceptability of using a text message appointment reminder intervention through WhatsApp. FGDs were recorded, transcribed, systematically coded, and analyzed with thematic categorization by trained researchers using a qualitative data analysis program ATLAS.ti (version 7)., Results: A community mobilization team comprising 34 SGM community leaders collaborated in creating a prototype for an mHealth educational tool and contributed to the planning of peer education activities. We created 3 process maps for each site to describe the initial visit, follow-up visits, and laboratory flow. The main challenge identified for same-day CAB-LA PrEP delivery was the extended duration of clinic visits due to the numerous laboratory tests and HIV counseling steps required. Proposed solutions included having point-of-care HIV rapid tests instead of laboratory tests and additional counseling staff. Barriers for CAB-LA PrEP implementation identified through FGDs were the training of HCPs, support for adherence to injection appointments, and stigma or discrimination against SGM groups and persons using PrEP. The mHealth educational tool and WhatsApp reminders were highly acceptable by SGM groups and HCPs, indicating their potential to support PrEP choice and adherence. Content analysis on the cultural appropriateness of the language and overall clarity of the material contributed to the refinement of the mHealth tool., Conclusions: Structured formative work with SGM persons and HCPs generated important refinements to context-specific materials and plans to launch ImPrEP CAB Brasil in public health clinics. Ongoing implementation monitoring will use the process maps to identify additional barriers and potential solutions to same-day delivery of CAB-LA PrEP. Summative evaluations are needed to measure the effectiveness of the mHealth educational tool to support PrEP choice and the use of WhatsApp appointment reminders., (©M Cristina Pimenta, Thiago Silva Torres, Brenda Hoagland, Mirian Cohen, Claudio Gruber Mann, Cristina M Jalil, Eduardo Carvalheira, Lucilene Freitas, Nilo Fernandes, Debora Castanheira, Marcos Benedetti, Julio Moreira, Keila Simpson, Roberta Trefiglio, Gabrielle O’Malley, Valdilea G Veloso, Beatriz Grinsztejn. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 24.10.2024.)

Background: Despite antiretroviral treatment (cART), aging people living with HIV (PWH) are more susceptible to neurocognitive impairment (NCI) probably due to synergistic/additive contribution of traditional cerebrovascular risk factors. Specifically, transmigration of inflammatory CD16+ monocytes through the altered blood brain barrier (BBB) may exacerbate cerebral small vessel disease (CSVD), a known cause of vascular cognitive impairment., Methods: PWH on cART (n=108) and age, sex, and Reynold's cardiovascular risk score-matched uninfected individuals (PWoH, n=111) were enrolled. This is a longitudinal observational study but only cross-sectional data from entry visit are reported. Neuropsychological testing and brain magnetic resonance imaging (MRI) were performed. CSVD was diagnosed by Fazekas score ≥1. Flow cytometric analyses of fresh whole blood were conducted to evaluate circulating levels of monocyte subsets (classical, intermediate, and non-classical) and markers of monocyte activation (CCR2, CD40, PSGL-1, TNFR2 and tissue factor). ELISAs were used to measure sCD14, ICAM, and Osteoprotegerin. Two-way analysis of variance (ANOVA), and linear regression models were performed to study the effects of HIV status, CSVD status, and their interaction to outcome variables such as cognitive score. Two-sample t-tests and correlation analyses were performed between and within PWoH with CSVD and PWH with CSVD participants., Results: PWH with CSVD (n=81) had significantly lower total cognitive scores, higher levels of NCMs and soluble CD14 and intracellular adhesion molecule 1 (ICAM-1) as compared to PWoH with CSVD group (n=68). sCD14 and ICAM1 were positively correlated with each other indicating that monocyte and endothelial activation are associated with each other. Cognition was negatively correlated with NCMs, especially in the PWH with CSVD group. Among other blood biomarkers measured, osteoprotegerin levels showed mild negative correlation with cognitive performance in individuals with CSVD irrespective of HIV status., Conclusions: Elevated levels of NCMs may contribute to neuroinflammation, CSVD and subsequent cognitive impairment. This finding is of particular relevance in aging PWH as both HIV and aging are associated with increased levels of NCMs. NCMs may serve as a potential biomarker to address these comorbidities. Further longitudinal studies are needed to evaluate whether changes in NCM levels are associated with changes in CSVD burden and cognitive impairment., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Singh, Uddin, Covacevich Vidalle, Sutton, Boodoo, Peterson, Tyrell, Tivarus, Wang, Sahin, Zhong, Weber, Wang, Qiu, Maggirwar and Schifitto.)

Background: HPTN 084 compared the safety and efficacy of long-acting injectable cabotegravir (CAB) to daily oral TDF/FTC for prevention of HIV-1 in uninfected African women. Like a similar trial in MSM/TGW (HPTN 083), the trial was stopped early for efficacy, expediting the need to consider introduction strategies for different populations. We examine survey and qualitative data from a four-country sub-study to examine oral and injectable PrEP acceptability and considerations for CAB access among African women., Methods: Participants completed baseline and follow-up surveys on HIV risk perception, sexual behavior. product acceptability and adherence during the blinded trial. Additionally, up to two in-depth interviews each with 73 sub-study participants explored product use and trial-related experiences, during the blinded and unblinded study periods. Using survey data, we classified participants as: engaged in female sex work (FSW), having multiple non-transactional partners, or monogamous. A study statistician identified participants' assigned study arm. We followed a thematic analysis process to read transcripts, develop a codebook and apply codes in NVivo to transcripts with intermittent intercoder reliability checks; using Excel matrices to explore differences across risk categories and study arms., Findings: Participants overwhelmingly preferred injections to pills, appreciating the ease, convenience, and privacy of a long-acting formulation. Many participants described challenges with contraceptive and/or study pill adherence, impeded by late night work, unexpected travel, or heavy drinking. Women in the TDF/FTC arm were more likely to describe side effects, compared to those in the CAB arm. Pain also varied widely by study arm. When considering post-trial access to CAB, limited PrEP knowledge, cost and concerns around stigma and poor service quality were potential access barriers., Conclusion: Women's desire for privacy and ease of use outweighed injectable concerns, resulting in a strong preference for CAB. Cost and accessibility will need to be addressed by implementation programs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Tolley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: HIV continues to have a disproportionate impact on specific populations in Malaysia, particularly men who have sex with men (MSM). HIV self-testing (HIVST) is a strategy that has been shown to scale up HIV testing rates. However, it faces shortcomings because of concerns about self-efficacy, result interpretation, and lack of counseling and linkage to care. This underscores the need for an innovative approach that integrates HIVST with timely counseling, expert guidance, and referrals to enhance engagement in relevant HIV prevention or treatment., Objective: This study aims to describe the protocol used in developing and testing a web-based platform (ie, CINTAI) providing an HIVST kit and real-time e-counseling to support online-to-offline linkage to HIV care services for MSM in Malaysia., Methods: The methods are reported according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines. In phase I, we will adapt existing HIVST web-based platforms to create a new online-to-offline HIVST and counseling platform called "CINTAI" for Malaysian MSM. In phase II, we will use a type 1 hybrid implementation trial design to determine the feasibility, acceptability, and preliminary efficacy of "CINTAI" compared with treatment as usual among Malaysian MSM, with assessments conducted over 6 months. Multilevel implementation factors will also be collected to guide future adoption and scale-up. We will enroll 78 MSM in the pilot randomized controlled trial. Baseline characteristics will be tested for homogeneity between groups using appropriate statistical tests. A generalized linear mixed model with random subject effects will account for within-subject correlation. Treatment assignment, time, interaction, and confounders will be included. The proportion of MSM tested for HIV over 6 months and other outcomes (pre-exposure prophylaxis for HIV or antiretroviral therapy linkage, HIV risk behaviors, and chemsex harm reduction) will be compared using linear contrasts., Results: We completed phase I of the proposed study in April 2024 and started phase II in May 2024, with 15 participants recruited (7 in the CINTAI and 8 in the treatment-as-usual groups). On the basis of a series of formative works completed during phase I, we developed a fully functional, web-based platform that provides a digital platform for MSM in Malaysia to order HIVST kits for free and to receive HIV counseling, followed by offline linkage to HIV prevention services (if HIV negative) or HIV treatment services (if HIV positive)., Conclusions: Despite being at high risk for HIV transmission, MSM in Malaysia have alarmingly low testing and linkage to HIV care services, prompting the need for innovative approaches to support HIV prevention efforts. If found to be feasible and acceptable, CINTAI can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries., International Registered Report Identifier (irrid): DERR1-10.2196/60962., (©Antoine Khati, Jeffrey A Wickersham, Kamal Gautam, Kiran Paudel, Panyaphon Phiphatkhunarnon, Sin How Lim, Kirthana Puniamurthy, Frederick L Altice, Nittaya Phanuphak, Iskandar Azwa, Roman Shrestha. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.10.2024.)

Pharmacy-based PrEP service delivery models can help address many of the barriers that inhibit the uptake of PrEP. In an increasing number of states, legislation has been passed, or is under consideration, to allow pharmacists to initiate PrEP without a prescription from a physician or other prescriber. However, there is not yet legislation in Washington, DC to allow pharmacy-based PrEP despite its potential to curb new cases of HIV, which disproportionately affect the Black community in the area. The DC Ends HIV Plan has a goal of less than 130 new cases of HIV per year by 2030, which would require that over 13,000 high-risk residents use PrEP. However, in 2021 only 6,724 Washingtonians were taking PrEP. This study seeks to address the absence of critical formative research into the factors that would influence the implementation of pharmacy-based PrEP in Washington DC using the Implementation Mapping (IM) framework. A needs assessment will be conducted through in-depth interviews (IDIs) with pharmacists (n = 6), PrEP providers (n = 6), current PrEP users (n = 6), DC Department of Health officials (n = 2), DC Board of Pharmacy officials (n = 4) and pharmacy-based PrEP experts (n = 4) to provide input on the operational aspects of pharmacy-based PrEP model as a strategy to increase PrEP uptake. Information gathered through this needs assessment will be used to develop standard operating procedures for the introduction of pilot pharmacy-based PrEP into community-based retail pharmacies., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Tun et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Development of novel therapeutic strategies that reactivate latent HIV and sensitize reactivated cells to apoptosis is crucial towards elimination of the latent viral reservoir. Among the clinically relevant latency reversing agents (LRA) under investigation, the γc-cytokine IL-15 and the superagonist N-803 have been shown to reactivate latent HIV ex vivo and in vivo. However, their clinical benefit can be hindered by IL-15 promoting survival of infected cells. We previously identified a small molecule, HODHBt, that sensitizes latently infected cells to death upon reactivation with γc-cytokines through a STAT-dependent pathway. In here, we aimed to identify and evaluate FDA-approved compounds that could also sensitize HIV-infected cells to apoptosis. Using the Connectivity Map (CMap), we identified the retinol derivative 13-cis-retinoic acid (Isotretinoin) causes similar transcriptional changes as HODHBt. Isotretinoin enhances IL-15-mediated latency reversal without inducing proliferation of memory CD4 T cells. Ex vivo analysis of PBMCs from ACTG A5325, where Isotretinoin was administered to ART-suppressed people with HIV, showed that Isotretinoin treatment enhances IL-15-mediated latency reversal. Furthermore, we showed that a combination of IL-15 with Isotretinoin promotes the reduction of translation-competent reservoirs ex vivo. Mechanistically, combination of IL-15 and Isotretinoin increases caspase-3 activation specifically in HIV-infected cells but not uninfected cells. Our results suggest that Isotretinoin can be a novel approach to target and eliminate translation-competent HIV reservoirs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Howard et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: To evaluate whether adolescents from sexual minorities who initiated pre-exposure prophylaxis (PrEP) in community-based organizations (COs) are more socially and HIV-vulnerable compared with their counterparts from a conventional health service. In addition, to evaluate whether these adolescents had more timely access to prophylaxis., Methods: A PrEP demonstration study was conducted in the city of São Paulo in two COs, located in the center (CO-center) and the outskirts (CO-outskirts), and a conventional HIV testing service (CTA-center). Between 2020 and 2022, cisgender male adolescents who have sex with men (aMSM), transgender and gender diverse adolescents (aTTrans) aged 15 to 19 years, HIV-negative, with higher-risk practices for HIV were eligible for PrEP. Indicators of timely access and vulnerabilities of adolescents initiating PrEP in COs were analyzed using CTA-center as a reference and multinomial logistic regression., Results: 608 adolescents initiated PrEP in COs and CTA-center. Adolescents from COs were associated with a shorter time to PrEP initiation (1-7 days; CO-outskirts: ORa = 2.91; 95%CI 1.22-6.92; CO-center: ORa = 1.91; 95%CI 1.10-3.31); and a lower housing Human Development Index (HDI) (CO-center: ORa = 0.97; 95%CI 0.94-1.00; CO-outskirts: ORa = 0.82; 95%CI 0.78-0.86). In CO-outskirts, there was an increased chance of adolescents being younger (ORa = 3.06; 95%CI 1.63-5.75) and living closer to the service (ORa = 0.82; 95%CI 0.78-0.86, mean 7.8 km). While adolescents from the CO-center were associated with greater prior knowledge of PrEP (ORa = 2.01; 95%CI 1.10-3.91) and high-risk perception (ORa = 2.02; 95%CI 1.18-3.44), adolescents from the COs were not associated with higher-risk sexual practices and situations of vulnerability to HIV., Conclusion: The provision of PrEP in the COs facilitated access for vulnerable adolescents and may contribute to reducing inequities.

Background: Globally, over 16 million children were exposed to HIV during pregnancy but remain HIV-free at birth and throughout childhood by 2022. Children born HIV-free (CBHF) have higher morbidity and mortality and poorer neurodevelopment in early life compared to children who are HIV-unexposed (CHU), but long-term outcomes remain uncertain. We characterised school-age growth, cognitive and physical function in CBHF and CHU previously enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe., Methods and Findings: The SHINE trial enrolled pregnant women between 2012 and 2015 across 2 rural Zimbabwean districts. Co-primary outcomes were height-for-age Z-score and haemoglobin at age 18 months (clinicaltrials.gov NCT01824940). Children were re-enrolled if they were aged 7 years, resident in Shurugwi district, and had known pregnancy HIV-exposure status. From 5,280 pregnant women originally enrolled, 376 CBHF and 2016 CHU reached the trial endpoint at 18 months in Shurugwi; of these, 264 CBHF and 990 CHU were evaluated at age 7 years using the School-Age Health, Activity, Resilience, Anthropometry and Neurocognitive (SAHARAN) toolbox. Cognitive function was evaluated using the Kaufman Assessment Battery for Children (KABC-II), with additional tools measuring executive function, literacy, numeracy, fine motor skills, and socioemotional function. Physical function was assessed using standing broad jump and handgrip for strength, and the shuttle-run test for cardiovascular fitness. Growth was assessed by anthropometry. Body composition was assessed by bioimpedance analysis and skinfold thicknesses. A caregiver questionnaire measured demographics, socioeconomic status, nurturing, child discipline, food, and water insecurity. We prespecified the primary comparisons and used generalised estimating equations with an exchangeable working correlation structure to account for clustering. Adjusted models used covariates from the trial (study arm, study nurse, exact child age, sex, calendar month measured, and ambient temperature). They also included covariates derived from directed acyclic graphs, with separate models adjusted for contemporary variables (socioeconomic status, household food insecurity, religion, social support, gender norms, caregiver depression, age, caregiver education, adversity score, and number of children's books) and early-life variables (length-for-age-Z-score) at 18 months, birthweight, maternal baseline depression, household diet, maternal schooling and haemoglobin, socioeconomic status, facility birth, and gender norms. We applied a Bonferroni correction for the 27 comparisons (0.05/27) with threshold of p < 0.00185 as significant. We found strong evidence that cognitive function was lower in CBHF compared to CHU across multiple domains. The KABC-II mental processing index was 45.2 (standard deviation (SD) 10.5) in CBHF and 48.3 (11.3) in CHU (mean difference 3.3 points [95% confidence interval (95% CI) 2.0, 4.5]; p < 0.001). The school achievement test score was 39.0 (SD 26.0) in CBHF and 45.7 (27.8) in CHU (mean difference 7.3 points [95% CI 3.6, 10.9]; p < 0.001); differences remained significant in adjusted analyses. Executive function was reduced but not significantly in adjusted analyses. We found no consistent evidence of differences in growth or physical function outcomes. The main limitation of our study was the restriction to one of two previous study districts, with possible survivor and selection bias., Conclusions: In this study, we found that CBHF had reductions in cognitive function compared to CHU at 7 years of age across multiple domains. Further research is needed to define the biological and psychosocial mechanisms underlying these differences to inform future interventions that help CBHF thrive across the life-course., Trial Registration: ClinicalTrials.gov The SHINE follow-up study was registered with the Pan-African Clinical Trials Registry (PACTR202201828512110). The original SHINE trial was registered at NCT https://clinicaltrials.gov/study/NCT01824940., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Piper et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: African, Caribbean, and Black (Black) communities in Canada are disproportionately affected by the HIV epidemic. Pre-exposure prophylaxis (PrEP) is a highly effective option for the prevention of HIV. However, the use of PrEP for HIV prevention among eligible Black clients in Canada remains far below the thresholds necessary to achieve the goal of zero new HIV infections. In a recent study in Toronto, PrEP-eligible Black clients were found to have decisional conflict and unmet decisional needs, which affected the quality of their decision-making process regarding the initiation and adherence to PrEP. There is evidence that decision support tools (DSTs) can improve the quality of a decision, the quality of the decision-making process, the implementation or continuation of the chosen option, and the appropriate use of health services. Despite these benefits, there is currently no DST for PrEP-eligible Black clients being asked to consider PrEP for HIV prevention., Objective: Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability., Methods: We developed and evaluated the PrEP DST for Black patients using the 7-step process outlined in the Ottawa Decision Support Group Guideline for the development and evaluation of DST. To facilitate the implementation of the Ottawa Decision Support Group guideline, we assembled a multidisciplinary team of primary health care providers, researchers, community members with lived experiences, and digital content designers to serve as the steering committee. First, we assessed patients' and primary health care providers' views on decisional support needs, after which we determined the content, design, and distribution plan for the DST. Subsequently, we conducted evidence synthesis, reviews, and appraisal before developing the PrEP DST prototype. The final tool was reviewed by steering committee members for completeness before acceptability and usability testing with potential Black clients and PrEP providers., Results: The web-based DST yielded 27 pages divided into 6 distinct sections. The six sections include (1) an introduction of the DST, (2) clarify your decision, (3) knowledge, (4) a value clarification exercise, (5) support system, and (6) next steps. Both Black clients and PrEP providers reported ease of task performance, general satisfaction, and usefulness of the tool to support decision-making for Black clients. Feedback on usability centered on the need to add a user guide to increase usability. All feedback was incorporated into the final tool., Conclusions: A PrEP DST for Black clients developed using a systematic process and a multidisciplinary steering committee was acceptable and usable by both Black clients and PrEP providers. Further study (eg, randomized controlled trials) may be needed to evaluate the efficacy of the PrEP DST., (©Wale Ajiboye, Abban Yusuf, Cheryl Pedersen, Rebecca Brown, Kristaps Dzonsons, LaRon Nelson. Originally published in JMIR Formative Research (https://formative.jmir.org), 11.10.2024.)

Background: Understanding the impact of natural disasters on the HIV epidemic in populations with high HIV burden is critical for the effective delivery of HIV control efforts. We assessed HIV risk behaviors, seroprevalence, and viral suppression in a high HIV prevalence Lake Victoria fishing community before and after COVID-19 emergence and lockdown and a severe lake flooding event, both of which occurred in 2020., Methods: We used data from the largest Lake Victoria fishing community in the Rakai Community Cohort Study, an open population-based HIV surveillance cohort in south-central Uganda. The data were collected both prior to (September-December 2018) and after (October-December 2021) COVID-19 emergence and a severe flooding event. Households impacted by flooding were identified via drone data and through consulting village community health workers. The entire study population was subject to extensive COVID-19-related lockdowns in the first half of 2020. Differences in HIV-related outcomes before and after COVID, and between residents of flooded and non-flooded households, were assessed using a difference-in-differences statistical modeling approach., Findings: A total of 1,226 people participated in the pre- and post-COVID surveys, of whom 506 (41%) were affected by flooding. HIV seroprevalence in the initial period was 37% in flooded and 36.8% in non-flooded households. After the COVID-19 pandemic and lockdown, we observed a decline in HIV-associated risk behaviors: transactional sex declined from 29.4% to 24.8% (p = 0.011), and inconsistent condom use with non-marital partners declined from 41.6% to 37% (p = 0.021). ART coverage increased from 91.6% to 97.2% (p<0.001). There was 17% decline in transactional sex (aPR = 0.83, 95% CI: 0.75-0.92) and 28% decline in the overall HIV risk score (aPR = 0.83, 95% CI: 0.75-0.92) among HIV-seronegative participants. We observed no statistically significant differences in changes of HIV risk behavior, seroprevalence, or viral suppression outcomes when comparing those affected by floods to those not affected by floods, in the periods before and after COVID-19, based on difference-in-differences analyses., Interpretation: Despite a high background burden of HIV, the COVID-19 pandemic, and severe flooding, we observed no adverse impact on HIV risk behaviors, seroprevalence, or virologic outcomes. This may be attributed to innovative HIV programming during the period and/or population resilience. Understanding exactly what HIV programs and personal or community-level strategies worked to maintain good public health outcomes despite extreme environmental and pandemic conditions may help improve HIV epidemic control during future natural disaster events., Competing Interests: The authors declare no competing interests., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Introduction: Poor mental health occurs more frequently among people living with HIV. Understanding what mental health problems occur and at what point during the continuum of HIV care is critical to ensure these problems are identified and appropriately addressed. We explored how mental health is experienced along the HIV care continuum in Rakai, Uganda., Methods: We conducted qualitative semi-structured in-depth interviews with 20 adults living with HIV and 10 health workers from March to December 2020. Interviews followed a timeline approach. Responses were analyzed using content analysis., Results: At the time of HIV diagnosis, nearly all participants described a range of strong emotions, including shock, fear and intense worry. Most participants described continued fear and intense worry leading up to, and at the time of, ART initiation. However, they said these emotions often subside after ART is initiated and viral suppression is achieved. Across interviews and at multiple points of the continuum, participants discussed how fear and worry led individuals to be "thinking too much" or be in "deep thoughts" and experience self-hatred. Individuals who stopped taking ART were thought to have more severe mental health problems ("madness", psychosis, suicidality). Participants were divided about the mental health of persons who returned to care after disengagement., Conclusion: In this setting, mental health problems experienced by people living with HIV are dynamic across the care continuum. With expanded HIV testing campaigns and Universal Test and Treat policies, targeted interventions for psychosocial support at the time of testing and ART initiation remain critical., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 West et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: HIV disproportionately affects sexual minority men (SMM; eg, gay, bisexual, and other men who have sex with men) in Lima, Peru; epidemiological data estimate that 32% to 39% of new HIV infections occur among adult cisgender SMM within primary partnerships (ie, male couples). Most HIV prevention-care research in Lima, Peru, has focused on SMM as individuals and not couples. To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral intervention (DHI) for adult cisgender SMM couples in Lima, Peru. The P3 DHI is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention care plan that aligns with their explicit sexual agreement. The P3 DHI is theoretically informed, self-guided, directed, sequential, and fully automated., Objective: This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples' formation and adherence to a detailed prevention care plan containing evidence-based strategies that also aligns with their explicit sexual agreement over time. In addition, the feasibility of enrollment and retention and couples' acceptability of P3 will be assessed., Methods: The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. After baseline, 60 enrolled SMM couples will be randomized to 1 of 2 conditions. Couples randomized to the unmatched, delayed control condition will receive access to the P3 DHI to use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to the P3 DHI for 6 months. Study assessments will occur at baseline and months 3 and 6. Descriptive, comparative, qualitative, and longitudinal analyses using generalized linear mixed-effect, multilevel, and actor-partner interdependence models will be conducted to address the specific aims., Results: The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and ended in April 2024. A total of 74 adult cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% (68/74) at month 6. Data are currently being analyzed to address the 3 specific aims regarding feasibility, acceptability, and preliminary efficacy., Conclusions: Findings from this research will reveal whether couples deemed the P3 DHI to be acceptable. Findings will also highlight the preliminary efficacy of the P3 DHI on couples managing their vulnerability to HIV and other sexually transmitted infections (STIs) over time via alignment of their prevention-care plan and sexual agreement. Trial findings will help shape the future direction of the P3 DHI while addressing the existing gap in prevention and care services for couples in the local context., Trial Registration: ClinicalTrials.gov NCT05873855; https://clinicaltrials.gov/study/NCT05873855., International Registered Report Identifier (irrid): DERR1-10.2196/63106., (©Jason W Mitchell, Zoran Bursac, David Diaz, Edward Michael Reyes Diaz, Alfonso Silva-Santisteban, Kelika A Konda. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.10.2024.)

Background: Identifying risk factors for respiratory syncytial virus (RSV)-associated severe acute respiratory illness (SARI) will assist with targeting vaccine interventions., Methods: Using surveillance data from South Africa (2012-2018), we compared the characteristics of individuals with RSV-associated influenza-like illness (ILI) (reference group) to those with RSV-associated SARI to describe factors associated with SARI using a multivariable analysis., Results: RSV was detected in 6% (483/7792) of ILI cases and 15% (844/5672) of SARI cases. Factors associated with SARI in children included age < 2 months, compared to age 2-4 years (adjusted odds ratio (aOR) 54.4; 95% confidence interval (CI) 23.5-125.8), malnutrition (aOR 1.9; 95% CI 1.2-3.2), prematurity (aOR 2.4; 95% CI 1.3-4.6) and living with HIV (LWH) (aOR 22.5; 95% CI 2.9-174.3). In individuals ≥ 5 years, factors associated with SARI included age ≥ 65 years compared to age 5-24 years (aOR 10.7; 95% CI 1.1-107.5), symptom duration ≥ 5 days (aOR 2.7; 95% CI 1.1-6.3), underlying illness (aOR 2.7; 95% CI 1.5-26.1) and LWH (aOR 16.8, 95% CI: 4.8-58.2)., Conclusion: Individuals at the extremes of age and those with identified risk factors might benefit most from RSV prevention interventions., Clinical Trial Number: Not applicable, this is not a clinical trial., (© 2024. The Author(s).)

Background: People living with HIV experience HIV stigma alongside a spectrum of aging-related health conditions that accelerate their vulnerability to the ill effects of loneliness and social isolation. Group-singing interventions are efficacious in improving psychosocial well-being among older people in the general population; however, the social curative effects of group singing have not been explored in relation to HIV stigma. By promoting group identification, bonding, and pride, group singing may reduce loneliness, social isolation, and other negative impacts of HIV stigma among older people living with HIV. Access to group-singing programs may be enhanced by technology., Objective: While group singing has been extensively studied in older adults, group-singing interventions have not been adapted for older people living with HIV to target loneliness and social isolation in the context of HIV stigma. The objective of this study was to describe the systematic development of a group-singing intervention to reduce loneliness and social isolation among older people living with HIV., Methods: In the San Francisco Bay Area between February 2019 and October 2019, we engaged older people living with HIV in a rigorous, 8-stage, community-engaged intervention adaptation process using the Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, and Testing (ADAPT-ITT) framework. On the basis of a formative assessment of the needs and preferences of older people living with HIV, we selected an evidence-based group-singing intervention for older adults and systematically adapted the intervention components by administering them to a community advisory council (n=13)., Results: The result was United Voices, a 12-week hybrid (web-based and in-person) group-singing intervention for older people living with HIV. United Voices comprises 12 web-based (ie, via Zoom [Zoom Video Communications]) rehearsals, web-based and in-person drop-in helpdesk sessions, and a professionally produced final concert recording., Conclusions: Through an iterative process and in consultation with stakeholders and topic experts, we refined and manualized United Voices and finalized the design of a pilot randomized controlled trial to evaluate the feasibility and acceptability of the intervention protocol and procedures. The findings provide insights into the barriers and facilitators involved in culturally tailoring interventions for older people living with HIV, implementing intervention adaptations within web-based environments, and the promise of developing hybrid music-based interventions for older adults with HIV., (©Miranda Hill, Meredith Greene, Julene K Johnson, Judy Y Tan. Originally published in JMIR Formative Research (https://formative.jmir.org), 08.10.2024.)

The objective of this study was to identify the prevalence and correlates of phosphatidylethanol (PEth) levels suggestive of unhealthy alcohol use among women living with and without HIV who self-reported no or low-risk drinking. We analyzed data from a cross-sectional study among women enrolled in the San Francisco Bay Area site of the Women's Interagency HIV Study (WIHS). Between October 2017 and March 2018, PEth was tested from dried blood spots in 192 women enrolled in the San Francisco site of the WIHS. Using multivariable logistic regression, we identified the correlates of PEth levels suggestive of unhealthy alcohol use (>50 ng/ml) among the 168 women who reported no or low-risk drinking (<7 drinks per week) in the past six months, while controlling for age in years and race/ethnicity. Among the 168 women in the analysis sample, the median age was 55; 51% identified as Black/African American, 47% were living with HIV and 28% had PEth levels ≥50 ng/ml which are suggestive of unhealthy alcohol use. Factors independently associated with PEth levels ≥50 ng/ml in adjusted models were: identifying as Black/African American (adjusted odds ratio [aOR] = 8.34, 95% CI = 2.06-33.72), having an alanine transaminase to aspartate aminotransferase ratio > 1 (aOR = 3.10, 95% CI = 1.18-8.13), higher high-density lipoprotein levels (aOR = 1.31 per 10 mg/dL increase, 95% CI = 1.01-1.70), and consuming a greater number of drinks per week in the past six months (aOR = 1.40, 95% CI = 1.10-1.78). Nearly a third of women in this study had PEth levels suggestive of unhealthy alcohol use and potentially under-reported their use. To optimize alcohol related health care, there is a need to consider approaches to improve ascertainment of unhealthy alcohol use, especially among Black/African American women and those living with liver disease, so that interventions can be initiated., Competing Interests: Dr. Judith Hahn consulted for Pear Therapeutics in 2022. All other authors declare no conflicts of interest., (Copyright: © 2024 Jain et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Research has shown that integrating community health workers (CHWs) into the formal health care system can improve outcomes for people living with HIV, yet there is limited literature exploring this framework among marginalized minority populations., Objective: Herein, we discuss the feasibility of a clinic-embedded CHW strategy to improve antiretroviral therapy adherence among Black people living with HIV in Miami-Dade County, Florida, a designated priority region for the US Department of Health and Human Services' Ending the HIV Epidemic Initiative., Methods: From December 2022 to September 2023, three CHWs were trained and integrated into the hospital workflow to provide support as members of the clinical team. Ten Black adults with an HIV viral load over 200 copies/mL were enrolled to received 3 months of CHW support focused on navigating the health system and addressing poor social determinants of health. Intervention feasibility was based on 4 criteria: recruitment rate, demographic composition, study fidelity, and qualitative feedback on CHW perceptions., Results: Participants were recruited at a rate of 5.7 participants per month, with the sample evenly distributed between men and women. Retention was moderately strong, with 7 (70%) of the 10 participants attending more than 75% of CHW sessions. Qualitative feedback reflected CHW perceptions on clinical interactions and intervention length., Conclusions: Outcomes indicate that a clinic-integrated CHW approach is a feasible and acceptable methodology to address adverse social determinants and improve HIV treatment adherence. By offering targeted social and clinical support, CHWs may be a promising solution to achieve sustained viral suppression and care engagement for Black people living with HIV., (©BreAnne Young, Olveen Carrasquillo, Deborah L Jones, Yue Pan, Sonjia Kenya. Originally published in JMIR Formative Research (https://formative.jmir.org), 04.10.2024.)

Background: Digital interventions to improve retention in HIV care are critical to ensure viral suppression and prevent further transmission. AIDS Healthcare Foundation Healthcare Centers are centers across the United States that provide primary HIV care. Traditionally, the Healthcare Centers conduct phone calls with patients to schedule and confirm appointments, as well as share laboratory results. In 2017, Healthvana piloted a digital platform at AIDS Healthcare Foundation Healthcare Centers to send patients SMS text message appointment reminders and allow patients to review their upcoming appointment and view their laboratory results in the web-based patient portal., Objective: A national implementation in 15 US states and Washington, DC, of this digital intervention pilot by Healthvana aims to determine whether SMS appointment reminders and web-based patient portal logins improved retention in care compared to traditional methods., Methods: A retrospective analysis of 40,028 patients living with HIV was conducted at the 61 AIDS Healthcare Foundation Healthcare Centers between January 2, 2017, and May 22, 2018. Patients were invited to enroll in Healthvana's digital intervention pilot, allowing for a natural, organization-wide case-control study. Separate binary logistic regression models evaluated the relationship between receiving SMS appointment reminders and completing scheduled appointments, as well as the relationship between logging into the web-based patient portal and completing scheduled appointments. Four scheduled consecutive appointments for each patient were included in the analysis to account for 1 full year of data per patient., Results: Patients who received the SMS appointment reminder were 1.7 times more likely to complete appointment 1 compared to patients who did not receive the SMS appointment reminder (P<.001). In addition, patients who received the SMS appointment reminder were 1.6 times more likely to complete appointment 2 (P<.001), 1.7 times more likely to complete appointment 3 (P<.001), and 1.8 times more likely to complete appointment 4 (P<.001) compared to patients who did not receive the SMS appointment reminder. Patients who logged in to the web-based patient portal prior to their scheduled appointment were 7.4 times more likely to complete appointment 1 compared to patients who did not log in (P<.001). In addition, patients who logged in to the web-based patient portal prior to their scheduled appointment were 3.6 times more likely to complete appointment 2 (P<.001), 3.2 times more likely to complete appointment 3 (P<.001), and 2.8 times more likely to complete appointment 4 (P<.001) compared to patients who did not log in., Conclusions: HIV primary care appointment completion was higher when patients engaged with Healthvana's digital platform. Digital technology interventions to ensure patients complete their scheduled HIV care appointments are imperative to curb the HIV epidemic., (©Adam Carl Sukhija-Cohen, Henna Patani, Michael Foxworth Blasingame, Kathy Linh Vu, Ramin Bastani. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 02.10.2024.)

BackgroundSweden reached the UNAIDS 90-90-90 target in 2015. It is important to reassess the HIV epidemiological situation due to ever-changing migration patterns, the roll-out of PrEP and the impact of the COVID-19 pandemic.AimWe aimed to assess the progress towards the UNAIDS 95-95-95 targets in Sweden by estimating the proportion of undiagnosed people with HIV (PWHIV) and HIV incidence trends.MethodsWe used routine laboratory data to inform a biomarker model of time since infection. When available, we used previous negative test dates, arrival dates for PWHIV from abroad and transmission modes to inform our incidence model. We also used data collected from the Swedish InfCareHIV register on antiretroviral therapy (ART).ResultsThe yearly incidence of HIV in Sweden decreased after 2014. In part, this was because the fraction of undiagnosed PWHIV had decreased almost twofold since 2006. After 2015, three of four PWHIV in Sweden were diagnosed within 1.9 and 3.2 years after infection among men who have sex with men and in heterosexual groups, respectively. While 80% of new PWHIV in Sweden acquired HIV before immigration, they make up 50% of the current PWHIV in Sweden. By 2022, 96% of all PWHIV in Sweden had been diagnosed, and 99% of them were on ART, with 98% virally suppressed.ConclusionsBy 2022, about half of all PWHIV in Sweden acquired HIV abroad. Using our new biomarker model, we assess that Sweden has reached the UNAIDS goal at 96-99-98.

Introduction: The South and Southeast Asia region has the second-highest number of people living with HIV globally. Despite progress in reducing HIV incidence and AIDS-related deaths, the region still has a long way to go in achieving the Joint United Nations Programme on HIV and AIDS (UNAIDS) 95-95-95 HIV testing, treatment and viral suppression targets. HIV self-testing (HIVST) is recommended by the World Health Organization as an additional approach to HIV testing. This paper provides a commentary on the implementation status, benefits, barriers and recommendations for HIVST implementation in South and Southeast Asia. Additionally, it presents perspectives from HIV testing service experts from 11 countries in the region to put forth recommendations to accelerate the implementation of HIVST in South and Southeast Asia., Discussion: There is uneven progress in national HIVST policy development and implementation across the region. HIVST, as an additional testing approach, can help to enhance testing coverage, frequency and demand for follow-up HIV services among key populations. Key factors influencing the implementation and scale-up of HIVST include the degree of awareness of HIVST among general and key populations, the development and implementation of supportive national HIVST policies and the availability of public funding for HIVST. To address barriers and leverage enablers to HIVST implementation, generating evidence on cost-effectiveness and budget impact, developing multisectoral partnerships for market shaping, promoting differentiated and decentralized delivery models, and optimizing linkage to further testing and care are recommended., Conclusions: It is crucial to accelerate the implementation and scale-up of HIVST to differentiate and decentralize the delivery of HIV testing services in South and Southeast Asian countries. Sharing experiences among country experts is vital to foster the adoption of best practices and facilitate the trial-and-error process of HIVST implementation. Such collaborative approaches can help South and Southeast Asian countries attain the UNAIDS 95-95-95 targets, especially the first 95 on HIV diagnosis, and play a significant role in ending the global AIDS epidemic., (© 2024 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Public health initiatives in Zambia encourage the uptake of early infant male circumcision (EIMC) as an HIV prevention strategy. This study assessed EIMC parental decision-making during perinatal care in Lusaka, Zambia, focusing on the influence of sociodemographic factors, family, and friends. A longitudinal pilot perinatal intervention, Like Father Like Son (LFLS), was implemented among 300 couples attending antenatal clinics in four urban community health centers. Participants were assessed postpartum regarding subsequent EIMC decisions. Partners, religion, and marital status were associated with the EIMC decision-making. Large scale EIMC promotion interventions that target both parents during perinatal care should be explored., (© 2024. The Author(s).)

Background & Aims: Equations estimating fat-free mass (FFM) in people living with the human immunodeficiency virus (HIV) show differences in the validation process. The current study aimed to verify the validity of FFM estimation equations derived from bioelectrical impedance (BIA) in people living with HIV aged 40 years and older., Methods: A cross-sectional study was conducted with 68 participants evaluated using dual-energy X-ray absorptiometry (DXA) and by two BIA devices (Analyzer and Biodynamics). The study aimed to determine the validity of six different FFM equations from four different studies by Lukaski and Bolonchuk (1987), Kotler et al. (1996), Beraldo et al. (2015) and Hegelund et al. (2017). Comparisons were made using the t-test or Wilcoxon test. To verify the validity between DXA and two BIA devices, the following statistical analyses were performed: Lin's concordance correlation coefficient, intraclass correlation coefficient, coefficient of determination, standard error of the estimate, differences in the limits of agreement by Bland and Altman analysis, correlation between the average and the differences of the methods by Pearson or Spearman correlation., Results: Only equation 2 of Kotler et al. (1996) for males by Biodynamics BIA showed no difference in FFM. The Lin's concordance correlation coefficient was excellent (0.96), irrespective of sex, for Equation 2 of Kotler et al. (1996) by BIA Analyzer. All equations were reproducible (>0.85). The coefficient of determination ranged from 68% to 92%, and the standard error of the estimates ranged from 1.8 kg to 5.0 kg. The differences between the limits of agreement ranged from 7.2 kg to 14.9 kg, and the correlations between the average and the differences of the methods showed differences in FFM for three equations (p < 0.01)., Conclusion: The choice of equations must consider the equipment used and the sex of the sample investigated. Only Equation 2 of Kotler et al. (1996) was considered valid, irrespective of sex, to estimate the FFM by BIA Analyzer., Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest., (Copyright © 2024 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

Background: Opioid use disorder (OUD) significantly impacts individual and public health and exacerbated further by concurrent infectious diseases. A syndemic approach is needed to address the intertwined OUD, HIV, and HCV epidemics, including the expanded use of medications for opioid use disorder (MOUD)., Methods: To identify MOUD scale-up opportunities, we conducted a retrospective cohort study, representing commercially insured persons, and created the OUD care continuum, including HIV and HCV influences in adults (18-64 years) newly diagnosed with OUD in 2019 using Merative MarketSan data., Results: Among 124,467,633 individuals, the prevalence of OUD was 0.4 % (95 % CI: 0.36 %-0.46 %; N = 497,871), with 327,277 (65.7 %, 95 % CI: 65.60 %-65.87 %) newly diagnosed in 2019. Among these newly diagnosed individuals (54 % men, mean age 44±0.01), 53,568 (27.0 %, 95 % CI: 26.4 %-27.5 %) were prescribed MOUD, with retention rates at 1, 3, and 6 months being 89.0 % (95 % CI: 88.2 %-89.8 %), 66.0 % (95 % CI: 64.8 %-67.2 %), and 50.3 % (95 % CI: 48.3 %-51.6 %), respectively. Buprenorphine was the most prescribed MOUD (79.6 %, 95 % CI: 78.6 %-80.7 %), followed by XR-NTX (14.9 %, 95 % CI:14.0 %-15.8 %) and methadone (5.5 %, 95 % CI: 4.9 %-6.1 %). Six-month retention was highest for methadone (73.4 %, 95 % CI: 73.0 %-73.8 %), however, followed by buprenorphine (55.7 %, 95 % CI: 55.3 %-57.1 %) and substantially lower for XR-NTX (12.6 %, 95 % CI: 10.6 %-14.6 %). Screening for HIV and HCV was low among OUD enrollees (11.1 %, 14.4 %), slightly higher for MOUD initiators (18.0 %, 21.6 %). Being prescribed MOUD was correlated with HCV infection (AOR: 2.54; 95 % CI: 2.41-2.68), HCV/HIV coinfection (AOR: 1.89; 95 % CI: 1.41-2.53), and hospitalization for OUD-related services (AOR: 1.14; 95 % CI: 1.11-1.17), yet hospitalization for OUD-related services was positively correlated with XR-NTX (AOR: 2.72; 95 % CI: 2.56-2.85) prescription and negatively with methadone (AOR: 0.19; 95 % CI: 0.16-0.23) prescription. Having HIV was negatively correlated with being prescribed methadone (AOR: 0.33; 95 % CI: 0.13-0.86)., Conclusions: Substantial gaps in the OUD cascade persist, underscoring better implementation opportunities for MOUD prescription in hospital-based settings and expanding access to methadone beyond highly regulated sites given its low coverage yet high treatment retention., Competing Interests: Declaration of Competing Interest The authors report no declarations of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Purpose of Review: This review summarizes differentiated service delivery (DSD) models for HIV treatment and prevention that have been adapted for maintaining continuity of services during the COVID-19 pandemic and proposes strategies for sustaining their benefits now and during future disruptions., Recent Findings: The COVID-19 pandemic resulted in an overburdened and disrupted health system, forcing countries to adopt and/or scale up DSD models for HIV services. While initially implemented as emergency measures, these models evolved and were refined over time to fit recipient needs ensuring continued HIV treatment and prevention services with minimal health system impact. Successful models employed task shifting, community-based delivery models, multimonth scripting and dispensing, and telehealth for remote consultation. DSD models enabled HIV services globally to be maintained during the COVID-19 pandemic. Though these models and adaptations were critical in addressing health gaps and disruptions caused by the pandemic, they were beneficial in improving efficiency and access to client-centered services and should be sustained., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Human immunodeficiency virus (HIV) co-infection is a major challenge for visceral leishmaniasis (VL) control, particularly in Ethiopia where the incidence of both pathogens is high. VL-HIV often leads to high rates of antileishmanial treatment failure and recurrent VL disease relapses. Considering the high prevalence of HIV and Leishmania in the Ethiopian population, preventing the progression of asymptomatic Leishmania infection to disease would be a valuable asset to VL disease control and to the clinical management of people living with HIV (PLWH). However, such a strategy requires good understanding of risk factors for VL development. In immunocompetent individuals living in Brazil, India, or Iran, the Human Leukocyte Antigen (HLA) gene region has been associated with VL development. We used NanoTYPE, an Oxford Nanopore Technologies sequencing-based HLA genotyping method, to detect associations between HLA genotype and VL development by comparing 78 PLWH with VL history and 46 PLWH that controlled a Leishmania infection, all living in a VL endemic region of North-West Ethiopia. We identified an association between HLA-A*03:01 and increased risk of VL development (OR = 3.89). These data provide candidate HLA alleles that can be further explored for inclusion in a potential Leishmania screen-and-treat strategy in VL endemic regions., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: W.A. received a travel grant by Omixon to participate in the European Federation for Immunogenetics conference to present the preliminary results of this work. Omixon had no role in study design, data collection and analysis, preparation of the manuscript, nor the decision to publish., (Copyright: © 2024 de Vrij et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Most new HIV infections are attributed to male-to-male sexual contact in the United States. However, only two-thirds of sexual minority men living with HIV achieve an undetectable viral load (UVL). We tested a web-based antiretroviral therapy adherence intervention called Thrive with Me (TWM) with core features that included medication self-monitoring and feedback, HIV and antiretroviral therapy information, and a peer-to-peer exchange., Objective: We assessed the efficacy of TWM on HIV UVL among adult (aged ≥18 years) sexual minority men. Moreover, we assessed the impact of overall engagement and engagement with specific intervention features on HIV UVL., Methods: In total, 401 sexual minority men (mean age 39.1, SD 10.8 y; 230/384, 59.9% African American) in New York City were recruited between October 2016 and December 2019 and randomized to receive TWM (intervention) or a weekly email newsletter (control) for 5 months. Computerized assessments occurred at baseline and months 5, 11, and 17. The primary outcome was a dichotomous measure of HIV UVL (≤20 copies/μL). Generalized estimating equations with robust SEs were used to assess the effect of the TWM intervention on HIV UVL over the follow-up period in an unadjusted model and a model adjusted for baseline differences and then stratified by baseline recent drug use urinalysis. In secondary analyses, generalized linear models were used to estimate risk differences in the association of overall engagement with TWM (the sum of the number of days participants accessed ≥1 screen of the TWM intervention out of a possible 150 days) and engagement with specific TWM components on HIV UVL throughout the 17-month intervention period., Results: Participant retention was 88.5% (355/401; month 5), 81.8% (328/401; month 11), and 80.3% (322/401; month 17). No consistent differences in HIV UVL were found between those randomized to receive TWM or the control at the 5- (difference-in-differences [DD]=-7.8, 95% CI -21.1 to 5.5), 11- (DD=-13.9, 95% CI -27.7 to 0.04), or 17-month (DD=-8.2, 95% CI -22.0 to 5.7) time points, or when stratified by baseline recent drug use. However, those TWM-assigned participants with high overall levels of engagement (in the upper 25th percentile) were more likely to have an HIV UVL at the end of the 5-month active intervention period compared to those with low engagement (below the 75th percentile; risk difference=17.8, 95% CI 2.5-33.0) or no engagement (risk difference=19.4, 95% CI 3.3-35.5) in the intervention. Moreover, high engagement with the peer-to-peer exchange was associated with HIV UVL over time in unadjusted models., Conclusions: TWM did not have overall impacts on HIV UVL; however, it may assist some sexual minority men who are highly engaged with this web-based intervention in achieving HIV viral suppression., Trial Registration: ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/study/NCT02704208., (©Keith J Horvath, Sara Lammert, Darin Erickson, K Rivet Amico, Ali J Talan, Ore Shalhav, Christina J Sun, H Jonathon Rendina. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 30.09.2024.)

Background: This pilot study evaluates the effectiveness of mobile talk-time incentives in maintaining participation in a longitudinal mobile health (mHealth) data collection program among people living with HIV in Lusaka, Zambia. While mHealth tools, such as mobile phone surveys, provide vital health feedback, optimal incentive strategies to ensure long-term engagement remain limited. This study explores how different incentive levels affect response rates in multiple survey rounds, providing insights into effective methods for encouraging ongoing participation, especially in the context of Zambia's prepaid mobile system and multi-SIM usage, a common practice in sub-Saharan Africa., Objective: This study aimed to assess the response rate success across multiple invitations to participate in a care experience survey using a mobile phone short codes and unstructured supplementary service data (USSD) model among individuals in an HIV care setting in the Lusaka, Zambia., Methods: Participants were recruited from 2 study clinics-1 in a periurban setting and 1 in an urban setting. A total of 2 rounds of survey invitations were sent to study participants on a 3-month interval between November 1, 2018, and September 23, 2019. Overall, 3 incentive levels were randomly assigned by participant and survey round: (1) no incentive, (2) 2 Zambian Kwacha (ZMW; US $0.16), and (3) 5 ZMW (US $0.42). Survey response rates were analyzed using mixed-effects Poisson regression, adjusting for individual- and facility-level factors. Probability plots for survey completion were generated based on language, incentive level, and survey round. We projected the cost per additional response for different incentive levels., Results: A total of 1006 participants were enrolled, with 72.3% (727/1006) from the urban HIV care facility and 62.4% (628/1006) requesting the survey in English. We sent a total of 1992 survey invitations for both rounds. Overall, survey completion across both surveys was 32.1% (637/1992), with significantly different survey completion between the first (40.5%, 95% CI 37.4-43.6%) and second (23.7%, 95% CI 21.1-26.4) invitations. Implementing a 5 ZMW (US $0.42) incentive significantly increased the adjusted prevalence ratio (aPR) for survey completion compared with those that received no incentive (aPR 1.35, 95% CI 1.11-1.63). The cost per additional response was highest at 5 ZMW, equivalent to US $0.42 (72.8 ZMW [US $5.82] per 1% increase in response)., Conclusions: We observed a sharp decline of almost 50% in survey completion success from the initial invitation to follow-up survey administered 3 months later. This substantial decrease suggests that longitudinal data collection potential for a care experience survey may be limited without additional sensitization and, potentially, added survey reminders. Implementing a moderate incentive increased response rates to our health care experience survey. Tailoring survey strategies to accommodate language preferences and providing moderate incentives can optimize response rates in Zambia., Trial Registration: Pan African Clinical Trial Registry PACTR202101847907585; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14613., (©Jacob Mutale, Kombatende Sikombe, Boroma Mwale, Mwansa Lumpa, Sandra Simbeza, Chama Bukankala, Njekwa Mukamba, Aaloke Mody, Laura K Beres, Charles B Holmes, Carolyn Bolton Moore, Elvin H Geng, Izukanji Sikazwe, Jake M Pry. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 30.09.2024.)

Background: Incident HIV during the perinatal period significantly impedes elimination of Mother-to-Child HIV Transmission (eMTCT) efforts. Pre-Exposure Prophylaxis (PrEP) effectively reduces HIV acquisition, and new agents like injectable Cabotegravir (CAB-LA) offer potential advantages for pregnant and breastfeeding women. The Pregnancy, Infant, and Maternal health Outcomes (PrIMO) study will compare rates of composite adverse pregnancy outcomes, and infant adverse events, growth and neurodevelopment between mother-infant dyads receiving CAB-LA and those receiving oral PrEP in Malawi., Methods: PrIMO is an observational cohort study involving: (1) the development of a PrEP Pregnancy Registry for longitudinal surveillance of pregnant women on PrEP in Malawi; and (2) the enrolment of a prospective safety cohort of 621 pregnant women initiating oral PrEP or CAB-LA and their subsequent infants. The registry will include all women continuing or initiating PrEP during pregnancy across targeted sites in Lilongwe and Blantyre districts. The safety cohort will enrol a subset of those women and their infants from Bwaila District Hospital in Lilongwe, Malawi. We hypothesize that CAB-LA's safety will be comparable to daily oral PrEP regarding adverse pregnancy outcomes, maternal/infant adverse events, and infant development. Participants in the cohort will choose either oral PrEP or CAB-LA and will be followed until 52 weeks post-delivery. Safety data will be collected from all mother-infant pairs and qualitative interviews will be conducted with a subset of purposively selected women (n = 50) to assess the acceptability of each PrEP modality., Discussion: The PrIMO study will provide critical data on the safety of CAB-LA in pregnant and breastfeeding women and their infants. Results will guide clinical recommendations as the Malawi Ministry of Health prepares for the rollout of CAB-LA to this population. Evaluation of Registry implementation will inform its expansion to a nationwide safety monitoring system for PrEP use during pregnancy, with implications for similar systems in the region., Trial Registration Number: NCT06158126. The study was prospectively registered (5 December 2023) in ClinicalTrials.gov., (© 2024. The Author(s).)

Background: Sub-Saharan Africa has been a technological hothouse when it comes to mobile phone technology adoption. However, evidence on the role played by mobile technology on infectious disease prevention has been mostly limited to experimental studies., Objective: This observational study investigates the role of mobile phone connectivity on HIV testing in sub-Saharan Africa., Methods: We make use of the novel and comprehensive OpenCelliD cell tower database and Demographic and Health Survey geocoded information for over 400,000 women in 29 sub-Saharan African countries. We examine, through ordinary least square and instrumental variable regressions, whether women's community distance from the closest cell tower influences knowledge about HIV testing facilities and the likelihood of ever being tested for HIV., Results: After finding a negative and significant impact of distance to the nearest cell tower on knowledge of HIV testing facility (-0.7 percentage points per unit increase in distance) and HIV testing (-0.5 percentage points per unit increase), we investigate the mechanisms through which such effects might occur. Our analysis shows that distance to a cell tower reduces HIV-related knowledge (-0.4 percentage points per unit increase) as well as reproductive health knowledge (-0.4 percentage points per unit increase). Similar results are observed when the analysis is performed at community level., Conclusions: Results suggest that the effect of mobile phone connectivity is channeled through increased knowledge of HIV, sexually transmittable infections, and modern contraceptive methods. Further analysis shows that cell phone ownership has an even larger impact on HIV testing and knowledge. This paper adds to the recent literature on the impact of mobile-based HIV prevention schemes by showing through large-scale analysis that better mobile network access is a powerful tool to spread reproductive health knowledge and increase HIV awareness., (©Francesco Iacoella, Nyasha Tirivayi. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 27.09.2024.)

Background: Mothers attending prevention of mother-to-child transmission (PMTCT) of HIV clinics seem to lack knowledge on many aspects of PMTCT, among which is breastfeeding. Breastfeeding recommendations in PMTCT have changed several times over the years leaving some confused and doubtful of what is currently recommended. One method shown to help improve their knowledge and acceptance of PMTCT recommendations is the use of peer educators. We sought to determine if mothers engage in discussions with other mothers during clinics and how these engagements influence trust in PMTCT recommendations., Methods: We interviewed 524 mothers with children under two years enrolled in PMTCT clinics in Kilimanjaro, Tanzania. We selected 5 clinics with the highest numbers of PMTCT enrolment from each district in the region. In each clinic, over a one-month period, we recruited all mothers attending the PMTCT clinic. We collected information on their engagement in discussions regarding PMTCT during clinics and how they perceived the information from their peers in relation to that from healthcare providers., Results: Fifty-five percent of the mothers reported engaging in peer discussions. Of the 90 (17%) mothers who reported noticing a change in PMTCT recommendations, 33 (36.7%) reported trusting previous recommendations more. A greater proportion (52.9%) of mothers who engaged in peer discussions reported trusting the information from peers more than that from healthcare workers., Conclusions: Peers have a great influence on mothers, which is concerning when their knowledge shared is outdated. Harnessing their influence and training them on current recommendations might be key to improving adherence to PMTCT recommendations., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Philemon et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy that consists in the use of antiretroviral drugs by seronegative people at risk of HIV. Negative perceptions, inadequate understanding, and access barriers have been associated with decreased medication adherence. Manaus is the largest city in the Brazilian Amazon, where the incidence of HIV/AIDS is high, and the rates of adherence to the antiretroviral treatment for HIV and PrEP are low. In this qualitative study among PrEP users, mostly MSM, we explored perceptions, knowledge, and access barriers. We conducted 21 in-depth interviews with an intentionally sampled group of participants who had used PrEP at least once in their lifetime, selected through the snowball technique, between April and July 2022. A thematic analysis was conducted with a predominantly inductive approach. We highlight three relevant themes: (i) access to information about PrEP and its influences on users, (ii) access, monitoring, and barriers encountered, and (iii) facilitators for PrEP adherence and sexual behaviors. One of the negative perceptions identified in the study involves a misunderstanding of the association between PrEP users and the HIV/AIDS status. Participants revealed that some non-PrEP users suspect that individuals claiming PrEP usage are concealing an HIV-positive status to engage in unprotected sex. Lack of information by health professionals regarding HIV prevention methods poses significant barriers to PrEP access and adherence. Participants emphasized social media's crucial role in PrEP awareness. The results suggest a need to increase digital outreach regarding PrEP, decentralize PrEP services, and provide comprehensive healthcare training to improve the effectiveness of the preventive measure., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Batista et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Behavioral factors increase the risk of contracting HIV. A comprehensive prevention services (CPS) intervention includes risk assessment and referral for those with confirmed risk. This project sought to assess the feasibility of an emergency department (ED)-based CPS program. A prospective cross-sectional assessment was conducted from October, 2021 through May, 2023, at a single ED in Birmingham, Alabama. Either of two screening methods were subjected to HIV negative adults: 1) manual chief complaint review or 2) objective electronic medical record (EMR) query. Manual and EMR screening methods considered sexually transmitted infections (STIs) or a positive urine drug test (to observe for commonly injectable drugs) within 12 months of current ED visit. Identified patients were approached in the ED (manual review) or via phone (EMR alert). Persons confirmed at risk for HIV following engagement questionnaire completion were made aware of their risk and offered referral to local CPS clinics. Primary outcome was CPS linkage. Descriptive analysis was performed. Of 184 patients approached, 147 agreed to engagement (79.9%), 117 in-person and 30 via phone; 125 (85.1%) were confirmed at risk for HIV; majority were white (66.4%), male (63.2%), between the ages of 30 and 49 (64.8%), uninsured (78.4%), and without a primary care provider (93.6%). Sexual behavior was identified as a recent (within six months) risk factor in 97 (77.6%) patients. Injection drug use was identified as a recent (within six months) risk factor in 71 (56.8%) patients. Fifty-four (43.2%) expressed interest in obtaining CPS follow-up. To-date, ten patients (18.5%) have connected with a CPS counsellor via phone and five (9.3%) have had a subsequent follow-up appointment to discuss CPS with a medical provider. Thirty at-risk patients (24.0%) received ED-initiated buprenorphine/naloxone. Targeted screening tools can aid in the identification of persons at risk for HIV in the ED; further, subsequent engagement and CPS implementation amongst this cohort is feasible. CPS clinic linkage may be challenging however, a CPS definition inclusive of ED-initiated medication for opioid use disorder, may offer opportunity for increased uptake., Competing Interests: The commercial funder does not alter our adherence to all PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Osman et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

PrEP cycling among women is thought to be safe when there are distinct "seasons of risk." However, cyclical PrEP use over short periods may be associated with increased risk of HIV acquisition. We aimed to characterize key social ecological factors contributing toward PrEP cycling among female sex workers (FSW) in the context of high HIV risk. Semi-structured, in-depth interviews were conducted with 36 FSW at risk for HIV acquisition and 12 key informant (KI) service providers in eThekwini (Durban), South Africa from January-October 2020. FSW identified key factors driving temporary discontinuation of PrEP including relocation, lack of information on or difficulty coping with side effects, and delays in accessing PrEP. In many cases, FSW were motivated to restart PrEP once barriers were overcome. In contrast, KIs emphasized the importance of individual adherence to PrEP and reliance on personal risk assessments when counselling FSW on cycling decisions. FSW and KI perspectives highlight a disconnect between providers' recommendations on the potential for cyclical use of PrEP during periods of minimal risk and actual drivers among FSW causing temporary PrEP discontinuation. Further interventions supporting safe PrEP cycling are needed to ensure decisions around cycling are deliberate and guided by changes in HIV risk rather than external factors., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Shipp et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Apart from HIV acquisition, men who have sex with men are at a higher risk of sexually transmitted infections, especially syphilis. Although the intersection between syphilis and HIV poses a formidable challenge among key populations who are known to be vulnerable to many health threats, there is little known about syphilis infection among MSM living with HIV in Ghana. This study seeks to investigate the burden of syphilis and address the existing knowledge gap by exploring behavioral, healthcare access, and structural factors influencing the syphilis burden within the HIV-positive MSM population., Method: This study was conducted in 2023 as part of the bio-behavioral survey (BBS) among men who have sex with men (MSM) in Ghana. A cross-sectional survey that used a respondent-driven sampling (RDS) approach was conducted in the old ten regions of Ghana. Data was collected on 3,420 participants, however, 857 HIV-positive MSM were included in this study since it focused on syphilis among HIV-positive MSM in Ghana. The study estimated the prevalence of syphilis among MSM living with HIV and provided a 95% confidence interval across different categories of explanatory variables. Bivariate and multivariable logistic regression models were used to identify factors associated with overall syphilis prevalence. All other analyses were weighted due to the complex design of the study., Results: The overall prevalence of syphilis was 23.83% (95% CI: 20.44, 27.58). HIV-positive men who only had sex with men had a 29.77% (95% CI: 23.90, 36.40) prevalence of syphilis compared to a prevalence of 9.50% (95% CI: 2.56, 29.53) recorded by HIV-positive MSM who were attracted to mostly females. Participants who ever had receptive anal sex recorded a higher prevalence 26.79% (95% CI: 22.78, 31.23) than those who never had receptive anal sex 12.86% (95% CI: 8.02, 19.99). The odds of syphilis among HIV-positive MSM who never used condoms with regular sex partners in the last 6 months were 41.08 (aOR: 41.08 at 95% CI 1.24-136.42; p = 0.038)., Conclusion: There is a high prevalence of syphilis among HIV-positive men who have sex with men in Ghana, especially among those who engage in unprotected anal sex and have multiple sexual partners. Our findings underscore the dire need for targeted interventions to address the dual brunt of HIV and syphilis among the MSM population in Ghana., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Guure et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Using the Olink Explore 1536 platform, we measured 1,463 unique proteins in 303 cerebrospinal fluid (CSF) specimens from four clinical centers contributed by uninfected controls and 12 groups of people living with HIV-1 infection representing the spectrum of progressive untreated and treated chronic infection. We present three initial analyses of these measurements: an overview of the CSF protein features of the sample; correlations of the CSF proteins with CSF HIV-1 RNA and neurofilament light chain protein (NfL) concentrations; and comparison of CSF proteins in HIV-associated dementia (HAD) and neurosymptomatic CSF escape (NSE). These reveal a complex but coherent picture of CSF protein changes with highest concentrations of many proteins during CNS injury in the HAD and NSE groups and variable protein changes across the course of systemic HIV-1 progression that included two common patterns, designated as lymphoid and myeloid patterns, related to principal involvement of their underlying inflammatory cell lineages. Antiretroviral therapy reduced CSF protein perturbations, though not always to control levels. The dataset of these CSF protein measurements, along with background clinical information, is posted online. Extended studies of this unique dataset will supplement this report to provide more detailed characterization of the dynamic impact of HIV-1 infection on the CSF proteome across the spectrum of HIV-1 infection, advancing the mechanistic understanding of HIV-1-related CNS pathobiology., Competing Interests: HZ has served at scientific advisory boards and/or as a consultant for Abbvie, Acumen, Alector, Alzinova, ALZPath, Amylyx, Annexon, Apellis, Artery Therapeutics, AZTherapies, Cognito Therapeutics, CogRx, Denali, Eisai, Merry Life, Nervgen, Novo Nordisk, Optoceutics, Passage Bio, Pinteon Therapeutics, Prothena, Red Abbey Labs, reMYND, Roche, Samumed, Siemens Healthineers, Triplet Therapeutics, and Wave, has given lectures in symposia sponsored by Alzecure, Biogen, Cellectricon, Fujirebio, Lilly, Novo Nordisk, and Roche, and is a co-founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is a part of the GU Ventures Incubator Program (outside submitted work). These organizations and companies had no role in the study design, data collection, decision to publish, or publication of the manuscript. MG has received research grants from Gilead Sciences and honoraria as speaker, DSMB committee member and/or scientific advisor from Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV, Janssen-Cilag, MSD, Novocure, Novo Nordic, Pfizer and Sanofi. These organizations and companies had no role in the study design, data collection, decision to publish, or publication of the manuscript., (Copyright: © 2024 Hu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Transgender women (hereafter "trans women") face social marginalization, stigma, and discrimination and experience a high burden of HIV. More recently, trans women have been identified as having a high risk for hepatitis C (HCV) infection. The interaction between these two diseases and the risks for HIV/HCV co-infection among trans women are understudied., Objective: To characterize epidemiological, behavioral, and socio-structural interactions between HIV and HCV infections among trans women., Methods: This cross-sectional study examined data from a community-based survey of trans women in San Francisco recruited through respondent-driven sampling (RDS) in 2019/2020. Face-to-face interviews collected data on demographics, medical history, drug injection practices, sexual behavior, and socio-structural factors (e.g., poverty, housing insecurity, incarceration, social support). HIV and HCV antibodies were detected using oral fluid rapid tests and prior diagnosis and treatment were collected by self-report. Blood specimens were collected to confirm antibodies using ELISA. Multinomial logistic regression analysis characterized factors associated with HIV infection alone, HCV infection alone, and HIV/HCV co-infection compared to neither infection., Results: Among 201 trans women recruited, HIV prevalence was 42.3%; HCV infection by history or current seroprevalence was 28.9%; evidence for both HIV and HCV infection was present for 18.9%. Two-thirds of trans women (67.2%) had been incarcerated; 30.8% had ever injected drugs. History of injection drug use and receiving emotional support from family were factors found in common for HIV infection, HCV infection, and HIV/HCV co-infection compared to no infection. Having a sexual partner who injects drugs was associated with HIV infection alone. Not lacking care due to cost and older age were associated with co-infection. Older age was also associated with HCV infection. Of trans women with HIV infection, 91.8% had accessed HIV care, whereas only 62% with HCV had accessed some form of care., Conclusions: Our study found high levels of HIV, HCV, and HIV/HCV co-infection among trans women in San Francisco. We found common associations between HIV and HCV through injection practices and emotional support, but having a sexual partner who injects drugs was not associated with HCV infection alone or co-infection. We note a substantial gap in the treatment of HCV for trans women, including those in HIV care, that needs to be urgently addressed., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Chiu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: HIV prevention is a public health priority. Despite progress in recent years, pre-exposure prophylaxis (PrEP) use remains suboptimal especially among groups disproportionately impacted by new HIV diagnoses such as gender and sexual minorities of color. Multiple barriers including a lack of PrEP providers and challenges with attending quarterly monitoring visits contribute to low PrEP uptake and retention. Home-based PrEP (HB-PrEP) services could reduce stigma, increase convenience, expand health system capacity for PrEP care, and improve PrEP retention., Objective: Home Option Testing for PrEP (HOT4PrEP) is a hybrid randomized controlled trial (RCT) that aims to examine whether HB-PrEP care is acceptable to PrEP users, feasible to implement in a sexual health clinic setting, and impacts PrEP retention., Methods: The RCT will recruit 458 persons currently taking or soon to initiate PrEP at a sexual health clinic in Seattle, Washington, and randomize them to continue the standard of care or have the option to use HB-PrEP for 2 of 3 triannual PrEP follow-up visits. Participants in the intervention arm will be sent home kits containing gonorrhea and chlamydia swabs and Tasso devices for blood self-collection. The primary outcome is PrEP retention between groups at 20 months; secondary outcomes include user satisfaction and acceptability, feasibility, self-reported PrEP adherence, and sexually transmitted infection (STI) incidence. Interviews with PrEP users and clinic staff will elucidate barriers and facilitators of implementation., Results: The HOT4PrEP RCT began enrolling in March 2022, was on hold during the height of the US mpox epidemic, then resumed enrollment in December 2022. Of the first 100 enrollees, the median age is 34 years, and most are cisgender gay men (89/100, 89%) with at least some college education (91/100, 91%). Among the 49 participants randomized to the HB-PrEP option, 33 (67%) chose to self-collect samples at home at least once, of whom 27 (82%) successfully returned test kits for HIV and STI testing. Primary PrEP retention and qualitative analyses are ongoing., Conclusions: Implementation of HB-PrEP into a high-volume sexual health clinic seems to be feasible and acceptable to early RCT enrollees. This strategy has the potential to address individual and systemic barriers associated with initiating and persisting on PrEP, such as increasing sexual health agency and expanding clinical capacity to serve greater numbers of PrEP users., Trial Registration: ClinicalTrials.gov NCT05856942; https://clinicaltrials.gov/study/NCT05856942., International Registered Report Identifier (irrid): DERR1-10.2196/56587., (©Chase Cannon, Katherine Holzhauer, Matthew Golden. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.09.2024.)