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Background: Addiction medicine providers have a key role in HIV prevention amidst rising HIV incidence in persons who inject drugs (PWID). Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are vastly underutilized in this population. Inpatient hospitalization represents a potential touchpoint for initiation of HIV prophylaxis, though little research explores the role of addiction providers. Here we describe rates of PrEP/PEP delivery to hospitalized PWID seen by an Addiction Consult Service (ACS) at an urban, essential hospital., Methods: We performed a cross-sectional study of hospitalized patients who were seen by the ACS from January 1, 2020 to December 31, 2022 and had plausible injection drug use. We calculated the proportion of patients who received a new prescription for PrEP/PEP at discharge. We used descriptive statistics to characterize demographics, substance use, reason for admission, and indications for PrEP/PEP. Secondarily, we calculated the monthly proportion of all patients discharged from the hospital with PrEP/PEP who were seen by the ACS compared to those not seen by the ACS., Results: The average monthly proportion of ACS consults with plausible injection drug use who received PrEP/PEP was 6.4%. This increased from 4.2% in 2020 to 7.5% in 2022. Those seen by the ACS who received PrEP/PEP had high rates of opioid use disorder (97.5%), stimulant use disorder (77.8%), and homelessness (58.1%); over half were admitted for an injection-related infection. The indications for PrEP/PEP were injection drug use only (70.6%), followed by combined injection and sexual risk (20.2%); 71.9% of prescriptions were for PrEP and 28.1% for PEP. Overall, the ACS was involved in 83.9% of hospital-wide discharges with PrEP/PEP prescriptions (n = 242)., Conclusions: PWID who were seen by the ACS received PrEP/PEP prescriptions at rates exceeding national averages. The ACS was also involved with the care of the majority of admitted patients who received PrEP/PEP at discharge. While PrEP/PEP use for PWID remains low, the inpatient ACS represents a key resource to improve uptake by leveraging the reachable moment of an inpatient hospitalization., (© 2024. The Author(s).)

Abstract: Substance use stigma is a barrier to care among people with HIV (PWH), which is exacerbated in the Deep U.S. South. Nurses and nonclinical staff serve a central role in strengthening and expanding care coordination in clinics that serve PWH. We sought to implement and evaluate a pilot training intervention that aimed to reduce substance use stigma among clinical and nonclinical staff who provide care for PWH in the Deep South. In total, 32 clinical and nonclinical staff from five clinics participated in the training, of whom 22% were nurses and 38% were linkage coordinators. We evaluated the association between the intervention and stigma by asking respondents about their agreement with varying levels of stigmatized statements both before and after the training. Overall, we observed a slight reduction in stigma scores. This training has promise as one low-burden approach to substance use stigma reduction in HIV care settings., (Copyright © 2024 Association of Nurses in AIDS Care.)

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.)

We evaluated correlates of adherence to PrEP, including daily oral tenofovir disoproxil fumarate in combination emtricitabine (oral FTC/TDF) and the monthly dapivirine ring (ring)among adolescent girls and young women (AGYW) in the MTN-034/REACH study. We enrolled 247 AGYW aged 16-21 years in South Africa, Uganda and Zimbabwe (ClinicalTrials.gov: NCT03074786). Participants were randomized to the order of oral FTC/TDF or ring use for 6 months each in a crossover period, followed by a 6-month choice period. We assessed potential adherence correlates-individual, interpersonal, community, study, and product-related factors-quarterly via self-report. We measured biomarkers of adherence monthly; high adherence was defined as > 4 mg dapivirine released from returned rings or intracellular tenofovir diphosphate levels ≥ 700 fmol/punch from dried blood spots (DBS). We tested associations between correlates and objective measures of high adherence using generalized estimating equations. High adherence to oral FTC/TDF was significantly associated with having an older primary partner (p = 0.04), not having exchanged sex in the past 3 months (p = 0.02), and rating oral FTC/TDF as highly acceptable (p = 0.003). High ring adherence was significantly associated with unstable housing (p = 0.01), disclosing ring use to a male family member (p = 0.01), and noting a social benefit from study participation (p = 0.03). All associations were moderate, corresponding to about 6%-10% difference in the proportion with high adherence. In our multinational study, correlates of adherence among African AGYW differed for oral FTC/TDF and the ring, highlighting the benefit of offering multiple PrEP options., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Sexually transmitted infections (STIs) are more commonly seen in patients with human immunodeficiency virus (PWH). Routine sexual history taking and appropriate multisite screening practices support prompt identification and treatment of patients, which in turn reduces morbidity and spread of STIs including HIV. Nucleic acid amplification testing has high accuracy for diagnosing many of the major STIs. Diagnosis of syphilis remains complex, requiring 2 stage serologic testing, along with provider awareness of the myriad symptoms that can be attributable to this disease. Prevention through mechanisms such as vaccines and postexposure prophylaxis hold promise to reduce the burden of STIs in PWH., Competing Interests: Disclosure Dr J. Tuan: no conflicts; Dr W. Trebelcock: no conflicts; Dr D. Dunne’s spouse holds stock in Pfizer, Inc., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Substance use disorders (SUD) are associated with HIV acquisition and care disruptions. Most research focuses on clinical samples; however, we used a nationally representative, community-based sample to estimate SUD treatment need and utilization by HIV status., Methods: We included participants from the 2015-2019 National Survey on Drug Use and Health aged 18 and older who met past-year DSM-IV SUD criteria (n = 22,166). Participants self-reported whether a healthcare professional ever told them they had HIV or AIDS [i.e., people with HIV (PWH), non-PWH, HIV status unknown]. Outcomes included past-year: 1) any SUD treatment use; 2) any specialty SUD treatment use; and 3) perceived SUD treatment need. Survey weighted multivariable logistic regression models estimated the likelihood of each outcome by HIV status, adjusting for age, sex, race/ethnicity, education, survey year, health insurance status, and household income., Results: Overall, 0.5 % were PWH and 0.8 % had an HIV unknown status. Any past-year SUD treatment utilization was low across all groups (10.3 % non-PWH, 24.2 % PWH, and 17.3 % HIV status unknown respondents). Specialty SUD treatment utilization was reported by 7.2 % of non-PWH, 17.8 % PWH, and 10.9 % HIV status unknown respondents. Perceived treatment need was reported by 4.9 % of non-PWH, 12.4 % of PWH, and 3.7 % of HIV status unknown respondents. In adjusted models, PWH were more likely than non-PWH to report any past-year SUD treatment utilization (aOR = 2.06; 95 % CI = 1.08-3.94) or past-year specialty SUD treatment utilization (aOR = 2.07; 95 % CI = 1.07-4.01). Among those with a drug use disorder other than cannabis, respondents with HIV-unknown status were less likely than HIV-negative individuals to report past-year perceived treatment need (aOR = 0.39; 95 % CI = 0.20-0.77)., Conclusions: Despite high SUD treatment need among PWH, more than three quarters of PWH with SUD reported no past-year treatment. Compared to non-PWH, PWH had higher treatment utilization and higher specialty treatment utilization, but SUD treatment was low across all groups. As SUD is associated with adverse HIV outcomes, our findings highlight the need for the integration of SUD treatment with HIV testing and care. Increasing access to SUD treatment could help reduce negative SUD-related outcomes along the HIV care continuum., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Inc. All rights reserved.)

The increased incidence of chronic diseases among people with HIV (PWH) is poised to increase the need for specialty care outside of HIV treatment settings. To reduce outcome disparities for HIV-associated comorbidities in the United States, it is critical to optimize access to and the quality of specialty care for underrepresented racial and ethnic minority (URM) individuals with HIV. We explored the experiences of URM individuals with HIV and other comorbidities in the specialty care setting during their initial and follow-up appointments. We conducted qualitative interviews with participants at three large academic medical centers in the United States with comprehensive health care delivery systems between November 2019 and March 2020. The data were analyzed using applied thematic analysis. A total of 27 URM individuals with HIV were interviewed. The majority were Black or African American and were referred to cardiology specialty care. Most of the participants had positive experiences in the specialty care setting. Facilitators of the referral process included their motivation to stay healthy, referral assistance from HIV providers, access to reliable transportation, and proximity to the specialty care health center. Few participants faced individual, interpersonal, and structural barriers, including the perception of individual and facility stigma toward PWH, a lack of transportation, and a lack of rapport with providers. Future case studies are needed for those URM individuals with HIV who face barriers and negative experiences. Interventions that involve PWH and health care providers in specialty care settings with a focus on individual- and structural-level stigma can support the optimal use of specialty care.

Germ-free (GF) mice, which are depleted of their resident microbiota, are the gold standard for exploring the role of the microbiome in health and disease; however, they are of limited value in the study of human-specific pathogens because they do not support their replication. Here, we develop GF mice systemically reconstituted with human immune cells and use them to evaluate the role of the resident microbiome in the acquisition, replication and pathogenesis of two human-specific pathogens, Epstein-Barr virus (EBV) and human immunodeficiency virus (HIV). Comparison with conventional (CV) humanized mice showed that resident microbiota enhance the establishment of EBV infection and EBV-induced tumorigenesis and increase mucosal HIV acquisition and replication. HIV RNA levels were higher in plasma and tissues of CV humanized mice compared with GF humanized mice. The frequency of CCR5 + CD4 + T cells throughout the intestine was also higher in CV humanized mice, indicating that resident microbiota govern levels of HIV target cells. Thus, resident microbiota promote the acquisition and pathogenesis of two clinically relevant human-specific pathogens., (© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Abstract: This cross-sectional observational study examined associations among symptom burden, lifetime duration of estrogen exposure, and serum antimüllerian hormone (AMH) levels among women living with HIV (n = 98) using bivariate bias-corrected Pearson correlations and multiple correspondence analyses. The mostly Black (85.6%) sample of women, with a mean age of 50 years (SD 12.6 years), exhibited no significant reproductive history factors and symptom burden interrelationships or significant associations between lifetime duration of estrogen exposure and symptoms. Predictably, serum AMH levels were lower among older women; however, less predictable were its significant relationships with months living with HIV (r = -0.362), months on ART (r = -0.270), and CD4+ T-cell nadir (r = 0.347). Symptom-symptom relationships support a fatigue, pain, sleep, anxiety, and depression symptom cluster. The hypotheses were not supported by cross-sectional observation. Further studies should explore variation in relationships between HIV, estrogen exposure, ovarian reserve, and AMH levels over time., (Copyright © 2024 Association of Nurses in AIDS Care.)

Background: Black women with HIV are impacted by mental health and substance use disorders alongside barriers to care. The impact of these disorders on retention in care, a crucial step of the HIV care continuum, has not been well-studied. We examined the association between these disorders and retention in care over a 2-year period., Methods: Data from January 1, 2011, to June 30, 2019, were obtained from the DC Cohort, an observational HIV study in Washington, District of Columbia. We examined the associations between mental health (i.e., mood-related or trauma-related) or substance use disorders, separately, on not being retained in HIV care over a 2-year interval post-enrollment among non-Hispanic Black women with HIV. Multivariate logistic regression with adjusted odds ratios (aORs) for sociodemographic and clinical variables was used to quantify the association of 1) having a confirmed mental health or substance use disorder and 2) not being retained in care., Results: Among the 2,181 women in this analysis, 690 (31.64%) were not retained in care. The prevalence of a mood-related disorder (39.84%) was higher compared with a substance use (16.19%) or trauma-related disorder (7.75%). Age per a 10-year increase (aOR 0.87; confidence interval [CI] 0.80, 0.94) and a mood-related disorder diagnosis (aOR 0.72; CI: 0.59, 0.88) were inversely associated with not being retained in care., Conclusion: Mood-related disorders were prevalent among Black women with HIV in Washington, District of Columbia, but were not associated with worse retention in care. Future studies should examine key facilitators for Black women with HIV and coexisting mood-related disorders and how they impact retention in care., (Copyright © 2023 Jacobs Institute of Women's Health, George Washington University. Published by Elsevier Inc. All rights reserved.)

The prevalence and control of hypertension (HTN) among people with HIV (PWH) have not been widely studied since the release of newer 2017 ACC/AHA guidelines ("new guidelines"). To address this research gap, we evaluated and compared the prevalence and control of HTN using both 2003 JNC 7 ("old guidelines") and new guidelines. We identified 3,206 PWH with HTN from the DC Cohort study in Washington, DC, between January 2018 and June 2019. We defined HTN using International Classification of Diseases (ICD)-9/-10 diagnosis codes for HTN or ≥2 blood pressure (BP) measurements obtained at least 1 month apart (>139/89 mm Hg per old or >129/79 mm Hg per new guidelines). We defined HTN control based on recent BP (≤129/≤79 mm Hg per new guidelines). We identified socio-demographics, cardiovascular risk factors, and co-morbidities associated with HTN control using multivariable logistic regression [adjusted odds ratio (aOR); 95% confidence interval (CI)]. The prevalence of HTN was 50.9% per old versus 62.2% per new guidelines. Of the 3,206 PWH with HTN, 887 (27.7%) had a recent BP ≤129/≤79 mm Hg, 1,196 (37.3%) had a BP 130-139/80-89 mm Hg, and 1,123 (35.0%) had a BP ≥140/≥90 mm Hg. After adjusting for socio-demographics, cardiovascular risk factors, and co-morbidities, factors associated with HTN control included age 60-69 (vs. <40) years (aOR: 1.42; 95% CI: 1.03-1.98), Hispanic (vs. non-Hispanic Black) race/ethnicity (aOR 1.49; 95% CI: 1.04-2.15), receipt of HIV care at a hospital-based (vs. community-based) clinic (aOR 1.21; 95% CI: 1.00-1.47), being unemployed (aOR 1.42; 95% CI: 1.11-1.83), and diabetes (aOR 1.35; 95% CI: 1.13-1.63). In a large urban cohort of PWH, nearly two-thirds had HTN and less than one-third of those met new guideline criteria. Our data suggest that more aggressive HTN control is warranted among PWH, with additional attention to younger patients and non-Hispanic Black patients.

The human immunodeficiency virus (HIV)-encoded accessory protein Nef enhances pathogenicity by reducing major histocompatibility complex I (MHC-I) cell surface expression, protecting HIV-infected cells from immune recognition. Nef-dependent downmodulation of MHC-I can be reversed by subnanomolar concentrations of concanamycin A ( 1 ), a well-known inhibitor of vacuolar ATPase, at concentrations below those that interfere with lysosomal acidification or degradation. We conducted a structure-activity relationship study that assessed 76 compounds for Nef inhibition, 24 and 72 h viability, and lysosomal neutralization in Nef-expressing primary T cells. This analysis demonstrated that the most potent compounds were natural concanamycins and their derivatives. Comparison against a set of new, semisynthetic concanamycins revealed that substituents at C-8 and acylation of C-9 significantly affected Nef potency, target cell viability, and lysosomal neutralization. These findings provide important progress toward understanding the mechanism of action of these compounds and the identification of an advanced lead anti-HIV Nef inhibitory compound.

The 2022 mpox outbreak primarily involved sexual transmission among men who have sex with men and disproportionately affected persons with human immunodeficiency virus (HIV). We examined viral dynamics and clinical features in a cohort evaluated for mpox infection at a comprehensive HIV clinic in Atlanta, Georgia. Viral DNA was found in 8 oropharyngeal and 5 anorectal specimens among 10 mpox cases confirmed by lesion swab polymerase chain reaction. Within-participant anatomic site of lowest cycle threshold (Ct) value varied, and lower Ct values were found in oropharyngeal and anorectal swabs when corresponding symptoms were present. This provides insight into mpox infection across multiple anatomic sites among people with HIV., Competing Interests: Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Open-Label Extension (OLE) studies are important in the drug development process and are used to further support the licensing applications and regulatory approvals of products. We aimed to understand why women chose to join the HOPE OLE study - where women were offered the dapivirine vaginal ring after two pivotal trials were completed - through data collected from individual in-depth interviews. Ten women at each of the six HOPE research sites in Lilongwe, Malawi; Durban (2 sites) and Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, were enrolled ( n  = 60). Access to an effective user-initiated HIV prevention product was one of the main reasons women joined HOPE. Although many participants worried that their male partners might expose them to HIV, they chose to remain in their relationships and avoid conflict or confrontation with their partners by discreetly using the ring to protect themselves. Other reasons for joining were quality healthcare, reimbursement and altruism. Researchers should better understand social and personal motivators behind research participation in order to recognize community sociocultural norms and its influences on product acceptability and adherence challenges.

People with HIV (PWH) with substance use disorders (SUD) have worse health outcomes than PWH without SUD. Our objective was to characterize substance use patterns and their impact on longitudinal HIV RNA trajectories among those enrolled in an observational study of PWH in care in Washington, DC. Substance use by type (alcohol, cannabis, opioid, stimulant, hallucinogen, inhalant, sedative) was used to identify shared patterns of substance use using Latent Class Analysis (LCA). A multinomial logistic regression model evaluated the association between the resulting substance use classes and the membership probability in longitudinal HIV RNA trajectory groups. There were 30.1% of participants with at least one substance reported. LCA resulted in a three-class model: (1) Low-Level Substance Use, (2) Opioid Use, and (3) Polysubstance. The Opioid and Polysubstance Use classes were more likely to have a mental health diagnosis (45.4% and 53.5%; p < 0.0001). Members in the Opioid Use class were older (median age of 54.9 years (IQR 50.3-59.2) than both the Polysubstance and Low-Level Substance Use Classes (p < 0.0001). There were 3 HIV RNA trajectory groups: (1) Undetectable, (2) Suppressed, and (3) Unsuppressed HIV RNA over 18 months of follow-up. The probability of being in the unsuppressed HIV RNA group trajectory when a member of the Opioid Use or Polysubstance Use classes was 2.5 times and 1.5 times greater than the Low-Level Substance Use class, respectively. The Opioid Use and Polysubstance Use classes, with higher-risk drug use, should be approached with more targeted HIV-related care to improve outcomes., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

To better understand male and female sexual partnerships among men who have sex with men (MSM), we used data from a 2019 biobehavioral survey among MSM in Harare and Bulawayo, Zimbabwe to conduct bivariate analyses and multivariable logistic regression to determine whether sociodemographic characteristics and HIV-related factors were associated with having both male and female sexual partnerships within the last 6 months. Of included MSM (N = 1143), 31% reported both male and female partnerships in the last 6 months. Being married/cohabiting (adjusted odds ratio (aOR) = 8.58, 95% confidence interval (CI) = 4.92-14.95) or separated/divorced/widowed (aOR = 1.96, 95% CI = 1.24-3.08) vs. being single, and hazardous alcohol consumption (aOR = 1.58, 95% CI 1.19-2.09) were associated with higher odds of having both male and female recent partnerships. Being aged 35 + vs. 18-24 (aOR = 0.50, 95% CI = 0.31-0.81), condomless receptive anal intercourse at last sex with the main male partner (aOR = 0.43, 95% CI = 0.26-0.74), and positive HIV status (aOR = 0.46, 95% CI = 0.31-0.67) were associated with lower odds of recent male and female partnerships. MSM in Harare who reported harassment/abuse (aOR = 3.16, 95% CI = 1.72-5.79) had higher odds of both male and female partnerships than MSM in Bulawayo reporting harassment/abuse. The prevalence of both male and female recent partnerships (31%) was lower among MSM in this survey than in other biobehavioral surveys of MSM in sub-Saharan Africa. Findings suggest that MSM with recent male and female partnerships compared to MSM with only male recent partners have lower odds of positive HIV status and participate in behaviors that lower HIV risk; however, the direction of these relationships cannot be determined due to the cross-sectional nature of the data. The findings also suggest a possible connection between experiences of stigma of MSM behavior and not having both male and female partnerships that warrants further exploration. Accessible, stigma-free HIV testing and education programming that considers the potential overlap between the MSM and general populations via both male and female partnerships and the associated behaviors could be a key component of HIV elimination in Zimbabwe., (© 2024. The Author(s).)

Long-acting injectable antiretroviral therapy (LAI ART) has the potential to address adherence obstacles associated with daily oral ART, leading to enhanced treatment uptake, adherence, and viral suppression among people living with HIV (PLWH). Yet, its potential may be limited due to ongoing disparities in availability and accessibility. We need a better understanding of the organizational context surrounding the implementation of LAI ART, and to inform its widespread rollout, we conducted 38 in-depth interviews with medical and social service providers who offer HIV care at private and hospital-based clinics across six US cities. Our findings highlight real-world implementation barriers outside of clinical trial settings. Providers described ongoing and anticipated barriers across three stages of LAI ART implementation: (1) Patient enrollment (challenges registering patients and limited insurance coverage), (2) medication delivery (insufficient personnel and resources), and (3) leadership and management (lack of interprofessional coordination and a lack of programming guidelines). Providers described how these barriers would have a disproportionate impact on under-resourced clinics, potentially exacerbating existing disparities in LAI ART access and adherence. Our findings suggest strategies that clinic leadership, policymakers, and other stakeholders can pursue to promote rapid and equitable LAI ART implementation in clinics across the United States. Resource and staffing investments could support clinics to begin, sustain, and scale up LAI ART delivery; additionally, the establishment of guidelines and tools could facilitate wider adoption of LAI ART across clinical settings. These efforts are crucial to promote resourced, standardized, and equitable implementation of LAI ART and maximize its potential to help end the HIV epidemic.

Kaposi sarcoma (KS) is the most common cancer in people living with HIV (PLWH) in many countries where KS-associated herpesvirus is endemic. Treatment has changed little in 20 years, but the disease presentation has. This prospective cohort study enrolled 122 human immunodeficiency virus (HIV) positive KS patients between 2017 and 2019 in Malawi. Participants were treated with bleomycin, vincristine and combination antiretroviral therapy, the local standard of care. One-year overall survival was 61%, and progression-free survival was 58%. The 48-week complete response rate was 35%. RNAseq (n = 78) differentiated two types of KS lesions, those with marked endothelial characteristics and those enriched in inflammatory transcripts. This suggests that different KS lesions are in different disease states consistent with the known heterogeneous clinical response to treatment. In contrast to earlier cohorts, the plasma HIV viral load of KS patients in our study was highly variable. A total of 25% of participants had no detectable HIV; all had detectable KSHV viral load. Our study affirms that many KS cases today develop in PLWH with well-controlled HIV infection and that different KS lesions have differing molecular compositions. Further studies are needed to develop predictive biomarkers for this disease., (© 2023 UICC.)

Background: Half of new HIV acquisitions in Africa occur in adolescent girls and young women. Pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate plus emtricitabine or the monthly dapivirine vaginal ring is efficacious but has lower adherence and effectiveness among adolescent girls and young women. We aimed to assess product adherence, safety, and choice of oral PrEP compared with the dapivirine ring among African adolescent girls and young women., Methods: MTN-034/REACH was a randomised, open-label, phase 2a crossover trial among HIV-seronegative, non-pregnant adolescent girls and young women aged 16-21 years at four clinical research sites in South Africa, Uganda, and Zimbabwe. Participants were randomly assigned (1:1) to either the dapivirine ring or daily oral PrEP (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) for 6 months, then switched to the other product option for 6 months, followed by a third 6-month period in which participants were given a choice of oral PrEP, the dapivirine ring, or neither. Fixed block randomisation was used, stratified by site. The primary adherence endpoint was use of each product during the randomised periods, with high use defined as tenofovir-diphosphate concentrations greater than or equal to 700 fmol/punch (associated with taking an average of four or more tablets per week in the previous month) and greater than or equal to 4 mg dapivirine released from the returned ring (continuous use for 28 days in the previous month) based on residual drug concentrations. The primary safety endpoint was grade 2 or higher adverse events during each randomised period of 24 weeks of ring and oral PrEP. This trial is registered at ClinicalTrials.gov, NCT03593655., Findings: From Feb 6, 2019 to Sept 9, 2021, 396 adolescent girls and young women were screened, 247 of whom were enrolled and randomly assigned (6 months of the ring followed by 6 months of oral PrEP n=124; 6 months of oral PrEP followed by 6 months of the ring n=123). Median age was 18 years (IQR 17-19). 54 grade 2 or higher product-related adverse events were reported during oral PrEP and five during dapivirine ring use, with no product-related serious adverse events. High adherence was observed in 753 (57%) of the 1316 oral PrEP visits and 806 (57%) of the 1407 dapivirine ring visits. Four women acquired HIV during follow-up., Interpretation: Adherence was moderately high and similar between oral PrEP and the dapivirine ring with favourable safety and tolerability. Oral PrEP and the dapivirine ring are effective, safe, and well tolerated HIV prevention options for adolescent girls and young women who would benefit from a choice of PrEP formulations to meet their needs and preferences., Funding: National Institutes of Health., Competing Interests: Declaration of interests CC has received consulting fees from Gilead Sciences and Merck, and has been an expert witness for Gilead. SLH has received consulting fees and funds to her institution from Merck. KN has received research funds from Merck (Merck Sharpe & Dohme). JMB and JFR are employees of Gilead Sciences. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

With the advancement of effective antiretroviral therapy, people with HIV live longer, and many are developing non-AIDS comorbidities. It is important to assess how comorbidities are associated with HIV-related health outcomes, such as viral suppression (VS). The aim of this study was to analyze the association between comorbidity burden, measured using a modified Quan-Charlson Comorbidity Index (QCCI), and VS (viral load result of <200 copies/mL). We hypothesized that an increase in QCCI score, indicating a higher risk for mortality, would correlate with lower likelihood of VS because of the burden of comorbidity treatment, possibly leading to worse antiretroviral adherence. Our analysis included participants from the DC Cohort Longitudinal HIV Study in Washington, DC. Eligible participants were aged ≥18 years and enrolled in the cohort as of January 1, 2018 ( n  = 2,471). A modified QCCI score, which weighs selected comorbidities (not including HIV/AIDS) and predicts mortality, was calculated using International Classification of Disease-9/10 codes from electronic health records. Multivariable logistic regressions were used to characterize the association between QCCI composite scores and VS. Participants were predominantly virally suppressed (89.6%), male (73.9%), non-Hispanic Black (74.7%), and between 18 and 55 years (59.3%). The median QCCI score was 1 (range = 1-12, interquartile range = 0-2), demonstrating predominately low mortality risk. We did not establish a statistically significant association between QCCI score and VS (adjusted odds ratio = 1.06, 95% confidence interval 0.96-1.17). Our findings suggest that a higher QCCI score was not associated with lower VS in this population, which may be partly due to the high retention in care among cohort participants.

Effective use of oral pre-exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in Eastern and Southern Africa, partly due to stigma and opposition from key influencers. Understanding AGYW's experiences of disclosure of different PrEP modalities to key influencers may inform strategies to motivate uptake and adherence. We analyzed qualitative in-depth interviews and focus group discussions data from 119 participants in the MTN-034/REACH (Reversing the Epidemic in Africa with Choices in HIV Prevention) study of oral PrEP and the dapivirine vaginal ring (ring) to explore AGYW's disclosure experiences. We found that AGYW disclosure experiences varied across influencers and product type. The ring was disclosed less often to most influencers, except partners, because it was discreet. Oral PrEP was disclosed more often, because pills were more common and to avoid HIV stigma given that oral PrEP resembled HIV treatment. Ultimately, disclosure typically led most key influencers to support product use through reminders and encouragement. While disclosure yielded positive support from influencers, further community awareness of both PrEP products is essential to reduce potential opposition and perceived stigma.Clinical Trial Number: NCT03593655., (© 2023. The Author(s).)

Housing instability can hinder the ability of people with HIV (PWH) to maintain engagement in care, adhere to antiretroviral (ART) regimens, and achieve viral suppression. This analysis examined the association between housing instability and HIV outcomes, as well as the association between housing status and substance use disorders, mental health disorders, and sexually transmitted infections. Multivariable logistic regressions were performed using data from the DC Cohort, a longitudinal cohort of PWH. Among 8622 PWH, unstably housed PWH were significantly more likely to be prescribed ART (aOR: 1.4; 95%CI: 1.1, 1.8) yet were significantly less likely to be virally suppressed (aOR: 0.6; 95%CI: 0.5, 0.8). Unstably housed PWH were also significantly more likely to have a substance use or mental health disorder, which may inhibit PWH's ability to achieve viral suppression. Efforts to end the HIV epidemic should address housing to ensure treatment is optimized for key populations.

Introduction: Effective use of pre-exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in sub-Saharan Africa. The MTN-034/REACH trial offered AGYW a menu of adherence support strategies and achieved high adherence to both daily oral PrEP and the monthly dapivirine vaginal ring. Understanding how these strategies promoted product use could inform the design of adherence support systems in programmatic settings., Methods: REACH was a randomized crossover trial evaluating the safety of and adherence to the ring and oral PrEP among 247 HIV-negative AGYW (ages 16-21) in South Africa, Uganda and Zimbabwe from January 2019 to September 2021 (NCT03593655). Adherence support included monthly counselling sessions with drug-level feedback (DLF) plus optional daily short message service (SMS) reminders, weekly phone or SMS check-ins, peer support clubs, "peer buddies" and additional counselling. Counsellors documented adherence support choices and counselling content on standardized forms. Through focus groups, serial in-depth interviews (IDIs) and single IDIs (n = 119 total), we explored participants' experiences with adherence support and how it encouraged product use., Results: Participants received counselling at nearly all visits. DLF was provided at 54.3% of sessions and, across sites, 49%-68% received results showing high adherence for oral PrEP, and 73%-89% for the ring. The most popular support strategies were in-person clubs and weekly calls, followed by online clubs, additional counselling and SMS. Preferences differed across sites but were similar for both products. Qualitative results demonstrated that the REACH strategies supported adherence by providing information about HIV and PrEP, continually motivating participants, and supporting the development of behavioural skills and self-efficacy, aligning with the Information, Motivation, and Behavioural Skills (IMB) model. Effectiveness was supported by three foundational pillars: strong interpersonal relationships with counsellors; ongoing, easily accessible support and resources; and establishing trust in the counsellors and study products through counsellor relationships, peer-to-peer exchange and DLF., Conclusions: Implementation programmes could support effective PrEP use by offering a small menu of counsellor- and peer-based support options that are youth-friendly and developmentally appropriate. The same menu options can support both ring and oral PrEP users, though content should be tailored to the individual products., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Globally, most countries have implemented a test-and-treat policy to reduce morbidity and mortality associated with HIV infection. However, the impact of this strategy has not been critically appraised in many settings, including Zambia. We evaluated the retention and clinical outcomes of adults enrolled in antiretroviral therapy (ART) and assessed the impact of the test-and-treat policy., Methods: We conducted a retrospective cohort study among 6,640 individuals who initiated ART between January 1, 2014 and July 31, 2016 [before test-and-treat cohort (BTT), n  = 2,991] and between August 1, 2016 and October 1, 2020 [after test-and-treat cohort (ATT), n  = 3,649] in 12 districts of the Southern province. To assess factors associated with retention, we used logistic regression (xtlogit model)., Results: The median age [interquartile range (IQR)] was 34.8 years (28.0, 42.1), and 60.2% ( n  = 3,995) were women. The overall retention was 83.4% [95% confidence interval (CI) 82.6, 84.4], and it was significantly higher among the ATT cohort, 90.6 vs. 74.8%, p  < 0.001. The reasons for attrition were higher in the BTT compared to the ATT cohorts: stopped treatment (0.3 vs. 0.1%), transferred out (9.3 vs. 3.2%), lost to follow-up (13.5 vs. 5.9%), and death (1.4 vs. 0.2%). Retention in care was significantly associated with the ATT cohort, increasing age and baseline body mass index (BMI), rural residence, and WHO stage 2, while non-retention was associated with never being married, divorced, and being in WHO stage 3., Conclusion: The retention rate and attrition factors improved in the ATT compared to the BTT cohorts. Drivers of retention were test-and-treat policy, older age, high BMI, rural residence, marital status, and WHO stage 1. Therefore, there is need for interventions targeting young people, urban residents, non-married people, and those in the symptomatic WHO stages and with low BMI. Our findings highlight improved ART retention after the implementation of the test-and-treat policy., 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 © 2023 Hamooya, Mutembo, Muyunda, Mweebo, Kancheya, Sikazwe, Sakala, Mvula, Kunda, Kabesha, Cheelo, Fwemba, Banda and Masenga.)

Objectives: Our objective was to increase human immunodeficiency virus (HIV) screening in adolescents presenting to our community pediatric emergency department with symptoms suggestive of a sexually transmitted infection (STI) and who were being tested for gonorrhea and chlamydia. Specifically, we aimed to increase the monthly average proportion of adolescents concurrently screened for HIV in this target group from 11% to 50% in 6 months., Methods: We identified barriers to HIV screening, focusing on physician-related challenges and adolescents' concerns about confidentiality. We designed interventions targeting these barriers and implemented them in plan-do-study-act cycles beginning in February 2020. We educated physicians and nurses about screening recommendations, emphasized a physician-conducted private interview during which confidential contact information could be obtained, and assured confidentiality on after visit summaries by removing STI results. We also provided regular feedback to physicians on the screening rate. In addition, we implemented an electronic health record quick order set and a documentation tool. Using a statistical process control chart, we measured the average monthly proportion of adolescents in the target group who were offered HIV screening or tested for HIV before and after interventions., Results: A total of 140 adolescents in the target group presented to our pediatric emergency department from February 2020 through December 2021. After plan-do-study-act cycles, the average monthly screening rate increased to 80%., Conclusions: Raising physician awareness of HIV screening recommendations and the importance of conducting a private interview improved screening rates. Assuring adolescent minors of confidentiality in a private interview, removing STI results from the after visit summary, and obtaining confidential contact information were important measures to overcome confidentiality barriers., Competing Interests: Disclosure: The author declares no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Cisgender women represent over half of people living with HIV globally. However, current research efforts toward a cure for HIV focus predominantly on cisgender men. The under-representation of women in HIV cure clinical studies is particularly problematic given data suggesting that sex-dependent phenotypes limit scientific discovery., Objective: We aimed to generate considerations to increase the meaningful involvement of women in HIV cure-related research., Materials and Methods: We conducted in-depth interviews with biomedical researchers and community members to better understand factors that could increase the meaningful involvement of women in HIV cure clinical trials. Participants were affiliated with academia, industry, community advisory boards, and community-based organizations, and were identified using listings from the AIDS Clinical Trials Group and the Martin Delaney Collaboratories. We used conventional content analysis to analyze the qualitative data., Results: We recruited 27 participants, of whom 11 were biomedical researchers and 16 were community members. Participants included 25 cisgender women, 1 transgender woman, and 1 cisgender man. Key considerations emerged, including the need to ensure that HIV cure studies reflect HIV epidemiologic trends and having accurate representation by sex and gender in HIV cure research. To increase the meaningful involvement of women, recommendations included instituting intentional enrollment goals, frequent and mandatory reporting on enrollment, and incentives for sites to enroll women. Additional themes included the need for agency and self-determination, attention to lived experiences, trauma and healing, and adequate support for women (e.g. logistical, psychosocial, mental, emotional, and physical). Participants noted that women would be willing to participate in HIV cure trials, related procedures (e.g. biopsies), and analytical treatment interruptions. They also expressed a desired for women-centered and holistic clinical trial designs that account for intersectionality., Conclusions: Our empirical inquiry extends recent calls to action to increase diversity of people involved in HIV cure research. Redressing the under-inclusion of women in HIV cure research is an urgent imperative. The entire field must mobilize and reform to achieve this goal. Meaningfully involving women across the gender spectrum in HIV cure research is needed to ensure that interventions are safe, effective, scalable, and acceptable for all people with HIV.

Introduction: Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation., Methods: AGYW aged 16-21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to summarize demographic and behavioral data while multinomial analysis was used to determine predictors of stated product preference (ring or oral PrEP)., Results: Of the 247 AGYW enrolled in REACH, 34% were aged 16-17 and 89% had a primary partner.The median age of sexual debut was 16 years and 40% had ever been pregnant. At screening, 35% of participants were diagnosed with a sexually transmitted infection (STI), 39% had an AUDIT-C score associated with harmful drinking and 11% reported intimate partner violence in the past 6 months. Overall, 28% of participants, had CESD-10 scores suggestive of depressive symptoms (≥12) in the past week. At baseline, similar proportions stated a preference for the ring and oral PrEP (38.1% and 40.5% respectively), with 19% of participants stating they preferred both products equally. Only study site was significantly associated with product preference (P<0.05) with AGYW from Johannesburg having higher odds of preferring the ring and those from Kampala having higher odds of preferring both options equally., Conclusions: We successfully enrolled African AGYW with a clear unmet need for HIV prevention. The balanced preference between the two products suggests that multiple biomedical prevention options may be appealing to this age group and could address their prevention needs., Competing Interests: The authors have declared that no competing interests exist, (Copyright: © 2023 Ngure 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 estimate the percentage of men in the U.S. in need of preconception care and to assess gaps in utilization of services by race/ethnicity and nativity, irrespective of intention for children, via cross-sectional analysis of 2017-2019 National Survey for Family Growth (NSFG)., Methods: The need for preconception care was defined as non-sterile men who had sexual experience and were with female partner(s) who were not sterile. Thirteen preconception care services were assessed across six domains: family planning, blood pressure, HIV, STD, weight management, and smoking cessation. Multivariable weighted analyses were performed to obtain odds ratios to assess differences in preconception care utilization among participants., Results: Approximately 64% of men were estimated to need preconception care. Substantial disparities in need and service use were found across sociodemographic characteristics. Foreign-born men had significantly higher odds of not receiving three of the thirteen preconception care services, including condom use screening (aOR = 1.67; CI = 1.23-2.26), HIV advice (aOR = 1.76; CI = 1.35-2.29), and STD testing (aOR = 1.66; CI = 1.13-2.44), than U.S.-born. Hispanic men had higher odds of not receiving blood pressure (aOR = 1.39; CI = 1.09-1.79) and smoking screenings (aOR = 1.33; CI = 1.02-1.73) than White men. Black men had the highest use in six of the thirteen preconception care services., Conclusion: Gaps in preconception care utilization suggest a need to further explore potential drivers of disparities, specifically for Hispanic and foreign-born men. Additional research into the timing and quality of care received by men are needed to assess the scope, severity, and prevalence of unmet needs within medically underserved communities., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Street-involved youth who use drugs (YWUD) face an elevated risk of HIV acquisition and represent a key population for HIV prevention initiatives, including pre-exposure prophylaxis (PrEP). However, little is known regarding the acceptability and feasibility of PrEP uptake and adherence among this multiply-marginalized population. Semi-structured qualitative interviews were conducted with 24 street-involved YWUD (ages 17-24) to examine their perspectives toward PrEP; youth were recruited through a longitudinal prospective cohort study in Vancouver, Canada. Youth reported high levels of ambivalence toward PrEP despite engagement in HIV-related risk behaviors. This ambivalence was driven by misperceptions regarding HIV transmission, including stigmatizing associations between HIV transmission and personal hygiene. Such misperceptions led participants to enact strategies that were ineffective in preventing HIV transmission. Participants contested their inclusion as a "key population" for PrEP, which limited their enthusiasm for PrEP uptake and adherence. Participants also highlighted that wider social-structural inequities (e.g., housing vulnerability, poverty) that produced HIV-related risks were likely to undermine sustained PrEP use. Findings demonstrate the need for tailored implementation strategies to increase PrEP acceptability, including targeted education and anti-stigma interventions to increase awareness about HIV transmission. Interventions should also target structural inequities in order to fully address HIV risk and PrEP ambivalence.

HIV and gender-based violence (GBV) are syndemic in sub-Saharan Africa and provision of support for participants who disclose GBV constitutes part of comprehensive care. Consequently, a process was undertaken to develop, implement, and evaluate standard operating procedures (SOPs) in MTN-025/HOPE, a study of the dapivirine vaginal ring for HIV prevention. The SOP was developed using needs assessment surveys in addition to World Health Organization (WHO) guidelines and other literature. Sites tailored and implemented the SOP through HOPE implementation. At study end, staff reported increased training 32/35 (91.43%); improved confidence (18/26; 69.23%); and improved vicarious trauma prevention onsite (17/28; 60.71%). Leadership reported increased staff competence in GBV response. Obstacles included limited referral organizations and time for follow-up, continued training needs, and cultural norms. Development and implementation of an SOP is a feasible strategy to build a GBV response to improve health systems and support sustained effective use of HIV prevention products., (© 2022. The Author(s).)

Aim: In the context of the continued overdose epidemic, recent population estimates of opioid use in highly affected groups, such as people at risk for or people living with HIV (PLWH), are essential for service planning and provision. Although nonmedical opioid use is associated with HIV transmission and with lowered adherence and care engagement, most studies rely on clinic-based samples and focus on medical use of opioids only. We examine associations between opioid-related outcomes by HIV status in a community-based nationally representative sample., Methods: The 2015-2019 National Survey on Drug Use and Health included 213,203 individuals aged 18 and older. Respondents self-reported whether a health care professional ever told them they had HIV/AIDS (i.e., HIV-positive/PLWH, HIV-negative, HIV-unknown). Opioid-related outcomes included past-year medical opioid use and past-year nonmedical (i.e., prescription opioid and heroin) use. Multinomial logistic regression estimated adjusted relative risk ratios between past-year opioid-related outcomes and HIV status, controlling for age, gender, race/ethnicity, income, population density, and year., Results: In 2015-2019, 0.2 % of respondents were PLWH and 0.3 % self-reported an HIV-unknown status. Past-year medical opioid use was 37.3 % among PLWH, 30.4 % among HIV-negative and 21.9 % among HIV-unknown individuals. Past-year nonmedical use was 11.1 % among PLWH, 4.2 % among HIV-negative and 7.2 % among HIV-unknown individuals. Compared to HIV-negative individuals, PLWH had 3.21 times higher risk of past-year nonmedical use vs. no use (95 % CI:2.02-5.08) and 2.02 times higher risk of past-year nonmedical vs. medical opioid use only (95 % CI:1.24-2.65)., Conclusion: Nonmedical opioid use prevalence was almost three times higher among PLWH than HIV-negative individuals. Because opioid use and its related harms disproportionately burden PLWH, integrating HIV and substance use prevention and treatment services may improve both HIV-related and opioid-related outcomes, including overdose., Competing Interests: Conflicts of interest None., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The continuous supply of affordable and quality HIV self-test (HIVST) is a key pillar toward achieving the global HIV 95-95-95 target in Nigeria. This was a descriptive qualitative study that explored private sector stakeholders' perceptions of the enablers and barriers of the HIVST market in Nigeria., Methods: A total of 29 In-depth interviews (IDIs) were conducted with HIVST supply chain stakeholders and private sector providers (PPMVs and Community Pharmacies). Responses were analyzed using Nvivo software and we systematically developed a total market approach analysis for supply chain stakeholders and archetypes for community Pharmacies and PPMVs based on insights gathered from their journey map., Results: Challenges to the supply side dynamics include forecasting, point of care service delivery, the availability of free and subsidized HIVST kits in the market, neglect of private sector providers (Community Pharmacists and PPMVs) in the healthcare delivery system, limited demand for HIVST, and regulatory bottlenecks influences the overall market dynamics. High cost of the HIVST kit, which triggers low availability, accessibility and affordability from the demand side, depicts the need to understand the market dynamics. Addressing the barriers and optimizing the enablers of the three-model pharmacist and PPMV's will change the market dynamic and service delivery to generate demand., Conclusion: To address challenges which already exist, the government need to revise the process guidelines for introducing new HIVST products in the Nigerian market, developing contingency plans to ensure the supply of HIVST remains sufficient when experiencing economic shocks, and create a sustainable roadmap toward optimizing the market for HIVST kits., (© 2023. The Author(s).)

Using the incidence of bacterial sexually transmitted infection (STI) as a surrogate for condomless sexual behavior, we assessed the association between STI and uncontrolled HIV replication among in-care persons with HIV (PWH) enrolled in a longitudinal HIV cohort study in the District of Columbia (the DC Cohort). Although STI occurrence initially correlated with higher HIV viral load (VL), this difference became more attenuated over time (2012-2016). This was true overall and among those with the greatest number of STIs [age 18-34, men who have sex with men (MSM)]. This likely reflects gains in population-wide virologic control through improved antiretroviral therapy and access to care, which helps mitigate the risk of HIV transmission., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The dapivirine vaginal ring ("the ring") reduced HIV acquisition by about 35% in phase III trials, with modeling from open-label extension trials estimating 50% HIV protection with consistent use. The ring may be used without male partner knowledge. The Assessment of ASPIRE and HOPE Adherence (AHA) substudy aimed to understand the impact of sociocontextual issues on ring adherence. This subanalysis provides insight into disclosure and male partner influence on ring acceptability., Methods: Data were collected using 4 focus group discussions with 18 male partners of phase III trial participants at 2 sites in KwaZulu-Natal, South Africa. Qualitative data were coded, summarized by urban vs. rural location, and analyzed thematically., Results: Male partners aged 23-49 years wanted to be informed about the ring use to maintain the trust in their relationships. Their initial response to the ring was characterized by fear due to perceived impact of the ring on their female partner's reproductive system, their penile safety, and that the ring would encourage women to engage in unprotected sex and infidelity. Over time and with information and experience with having a partner who had used the vaginal ring, this fear transformed to support for women to have their own HIV prevention option., Conclusion: Male partners supported the ring as an HIV prevention method for women but wanted to be informed about its use. Engaging male partners on female-initiated HIV prevention methods and increased education among rural men may contribute to improved partner support and facilitate women's consistent use., Competing Interests: The authors have no conflict of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

The Ending the HIV Epidemic initiative aims to decrease new HIV infections and promote test-and-treat strategies. Our aims were to establish a baseline of HIV outcomes among newly diagnosed PWH in Washington, DC (DC), a 'hotspot' for the HIV epidemic. We also examined sociodemographic and clinical factors associated with retention in care (RIC), antiretroviral therapy (ART) initiation and viral suppression ( VS ) among newly diagnosed PWH in the DC Cohort from 2011-2016. Among 455 newly diagnosed participants, 92% were RIC at 12 months, ART was initiated in 65% at 3 months and 91% at 12 months, VS in at least 17% at 3 months and 82% at 12 months and 55% of those with VS at 12 months had sustained VS for an additional 12 months. AIDS diagnosis was associated with RIC (aOR 2.99; 1.13-2.28), ART initiation by 3 months (aOR 2.58; 1.61-4.12) and VS by 12 months (aOR4.87; 1.69-14.03). This analysis contributes to our understanding of the HIV treatment dynamics of persons with recently diagnosed HIV infection in a city with a severe HIV epidemic.

The HIV Prevention Ambassador Training Package for Adolescent Girls and Young Women was created in collaboration with adolescent girls and young women (AGYW) to improve skills, knowledge, and attitudes about oral pre-exposure prophylaxis (PrEP) among peer "ambassadors". It was field tested with 17 ambassadors in Mazowe District, Zimbabwe and changes in ambassadors' knowledge and attitudes about oral PrEP, as well as changes in oral PrEP uptake among AGYW in the district, were assessed. The training package improved oral PrEP knowledge among trained ambassadors and built AGYW's skills to advocate for oral PrEP awareness and rollout. Use of the training package correlated with a 59% increase in oral PrEP uptake among AGYW in Mazowe District in the seven months following the training. The ambassador training package could help support oral PrEP introduction and scale up in countries with high HIV incidence by engaging AGYW in oral PrEP rollout in their communities.

Prostate cancer treatments disrupt receptive anal intercourse (RAI) for gay and bisexual men (GBM). Sexual dysfunction following prostate cancer treatment may include severe pain in the anorectum during RAI (i.e., anodyspareunia). The purpose of this study was to explore the impact of prostate cancer and its treatments on RAI among GBM. Data were from a cross-sectional online survey of 100 GBM prostate cancer survivors who reported pleasurable RAI prior to treatment. Approximately 47% of the sample reported recent RAI, which was more common among GBM in long-term relationships. RAI was also associated with engagement in other sexual behaviors (e.g., oral and insertive anal sex). Anodyspareunia was reported by 23% of the men who had attempted recent RAI. Anodyspareunia was negatively associated with mental health, performing oral sex on a partner, and bowel function. The overwhelming majority received no information from their healthcare providers about loss of RAI function prior to prostate cancer treatment. Culturally responsive cancer survivorship care may need to address the loss of RAI function for GBM prostate cancer survivors.

While infectious diseases (ID) are a well-documented public health issue in carceral settings, research on ID screening and treatment in jails is lacking. A survey was sent to 1,126 jails in the United States to identify the prevalence of health screenings at intake and characteristics of care for ID; 371 surveys were completed correctly and analyzed. Despite conflicting Centers for Disease Control (CDC) guidance, only seven percent of surveyed jails test individuals for HIV at admission. In 46% of jails, non-healthcare personnel perform ID screenings. Jails in less urban areas were more likely to report healthcare screenings performed by correctional officers. Survey findings indicate that HIV, HCV and TB testing during jail admissions and access to PrEP are severely lacking in less urban jails in particular. Recommendations are provided to improve ID surveillance and address the burden of ID in correctional facilities., Competing Interests: The authors have declared that no competing interests exist.

People who inject drugs (PWID) have extraordinarily low uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) despite high levels of need. Long-acting PrEP modalities hold promise for HIV prevention among PWID, but product preferences remain poorly understood. From September to November 2021, we conducted qualitative interviews with 28 HIV-negative, adult (≥18 years) PWID in San Diego County, CA, to explore their perspectives on daily oral PrEP pills and long-acting PrEP modalities (i.e., injections, implants, intravaginal rings, and broadly neutralizing antibodies), which we explained using standard scripts. Thematic analysis identified variations in PrEP modality interest and acceptability. We identified three key factors across the 28 interviews that appeared to influence PrEP modality preferences: perceived convenience of use, invasiveness, and familiarity (based on past experience). Overall, most participants preferred injectable PrEP over other modalities because they viewed injectable medications as convenient, noninvasive, and familiar. While injectable PrEP was recently approved for use in the United States and was most the acceptable PrEP modality in this sample, our findings suggest that intervention and implementation research is urgently needed to improve our understanding of strategies that could support access, uptake, and sustained adherence to longer-acting PrEP for PWID.

Ultra-long-acting integrase strand transfer inhibitors were created by screening a library of monomeric and dimeric dolutegravir (DTG) prodrug nanoformulations. This led to an 18-carbon chain modified ester prodrug nanocrystal (coined NM2DTG) with the potential to sustain yearly dosing. Here, we show that the physiochemical and pharmacokinetic (PK) formulation properties facilitate slow drug release from tissue macrophage depot stores at the muscle injection site and adjacent lymphoid tissues following single parenteral injection. Significant plasma drug levels are recorded up to a year following injection. Tissue sites for prodrug hydrolysis are dependent on nanocrystal dissolution and prodrug release, drug-depot volume, perfusion, and cell-tissue pH. Each affect an extended NM2DTG apparent half-life recorded by PK parameters. The NM2DTG product can impact therapeutic adherence, tolerability, and access of a widely used integrase inhibitor in both resource limited and rich settings to reduce HIV-1 transmission and achieve optimal treatment outcomes., (© 2022. The Author(s).)

Women account for a disproportionate percentage of new HIV infections in sub-Saharan Africa indicating a need for female-initiated HIV prevention options congruent with their lifestyles. The dapivirine vaginal ring for HIV prevention is one such option. We explored the interest of women, who used this ring during the Microbicide Trials Network's ASPIRE and HOPE studies, in using the ring post-licensure and what they perceived as important considerations for future use. We also explored perspectives of HOPE participants' male partners on their involvement in their partners' future ring use. Women appeared keen to use the ring in the future and expressed desires for easy access, support for both ongoing and new users and intense community engagement. In parallel, male partners indicated high levels of interest in supporting their partners' ring use and being involved in ring use decision making. These data offer important insights for ring rollout planning and engagement activities., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: Fat redistribution from subcutaneous adipose tissue (SAT) to the abdominal viscera, pericardium, liver, and skeletal muscle contributes to the rising burden of cardiometabolic disease among persons with HIV (PWH). Previous studies found SAT inflammation in PWH impairs lipid storage and persists despite plasma viral suppression on antiretroviral therapy (ART). In this study, we identified SAT immune-related genes associated with ectopic fat deposition in PWH on long-term ART., Design and Methods: A total of 92 PWH with well-controlled viremia underwent computed tomography imaging and abdominal SAT biopsy for gene expression analysis. SAT gene expression was measured using a NanoString panel of 255 immune-related genes. Associations between gene expression and computed tomography measurements of the volume and attenuation (radiodensity) of metabolically relevant ectopic fat depots were assessed using multivariable linear regression and network analysis., Results: Greater SAT volume was associated with higher visceral and pericardial adipose tissue volume, but lower skeletal muscle attenuation. Lower SAT attenuation, a measure of lipid content, was associated with lower visceral adipose tissue attenuation. Hierarchical clustering identified a subset of macrophage-related genes in SAT, including CCL2, CCL22, CCL13, CCR1, CD86, CD163, IL-6, IL-10, MRC1, and TREM2, which were associated with an increased lipid deposition in multiple ectopic depots., Conclusion: Altered expression of macrophage-related genes in SAT is associated with differences in ectopic fat depot morphometrics among PWH on long-term ART, including in the pericardial and visceral compartments. These findings provide basis for future studies to assess host, virus, and treatment factors shaping the SAT immune environment and its effects on morphometric changes and metabolic comorbidities in PWH., Competing Interests: J.R.K. has served as a consultant to Gilead Sciences, Merck, ViiV Healthcare, Janssen, and Theratechnologies and has received research support from Gilead Sciences and Merck. C.N.W. has served as a consultant to ViiV Healthcare. J.A.K. has served as a consultant for Boehringer Ingelheim, Janssen, and APIE Therapeutics, received grant support from Boehringer Ingelheim and Bristol-Meyers-Squibb, and other study support from Genentech. S.N., J.G.T., and J.J.C. receive grant support from Theratechnologies and IBM Watson. The remaining authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: A nutritious diet is critical to minimizing disease progression of human immunodeficiency virus (HIV) and maximizing treatment efficacy. In low resource settings, meeting the food preference needs of people living with the HIV (PLHIV) can be achieved with a supportive food environment when HIV status is disclosed. However, less is known about family-level strategies related to building a supportive food environment. The Diet, Environment, and Choices of positive living (DECIDE), a mixed-methods observational study conducted in peri-urban Dar es Salaam, Tanzania, explored food preferences as influenced by the personal, family, and external food domains., Methods: We completed a qualitative analysis of data generated from 40 interviews (n = 20 PLHIV and n = 20 family members) aimed at exploring the dynamics of food choice for using a family perspective. We expanded on Turner's food environment framework and drew on Giddens' structuration theory to guide our data collection and analysis. Interviews were audio recorded, transcribed, translated from Kiswahili to English, coded, and organized into themes., Results: We found PLHIV personal food preferences were influenced by organoleptic properties, medications, disease stage, and gender norms. Family members were knowledgeable about the importance of nutritious food for HIV treatment and prioritized these needs to avoid HIV-related stigma and fulfill family obligations. With high prices of nutritious foods (animal source foods, fruits), family members strategized to secure preferred foods for the PLHIV by, 1) forgoing their own food preferences; 2) reallocating food within the household; 3)making food substitutions; and 4) leveraging external networks. These strategies were increasingly employed as the disease progressed., Conclusion: The use of this expanded framework that included a family perspective on PLHIV food choice illuminated the various households decision-making dynamics that took place in this low resource community. Family members of PLHIV tried to buffer the limitations imposed by the external food environment, especially as the disease progressed. In the context of HIV status disclosure, integrating a family perspective into HIV nutrition interventions and programs has the potential to influence health outcomes and slow disease progression., (© 2022. The Author(s).)

As demonstrated by the Phase III clinical trial, MTN-020/ASPIRE, the monthly dapivirine vaginal ring is well tolerated and reduces the risk of HIV-1 as a woman-initiated prevention option. This analysis uses data from the follow-on MTN-032/Assessment of ASPIRE and HOPE Adherence (AHA) qualitative study to understand how perceptions (or misperceptions) of ring efficacy may have influenced behavior during ASPIRE, and affected intention to use the ring in future ring projects, specifically HOPE, the planned open-label extension study. Single in-depth interviews (n = 98) and 12 focus group discussions (n = 89) were conducted with women at seven sites in Malawi, South Africa, Uganda and Zimbabwe. Eligibility included participation in the ASPIRE active arm, and ring use for ≥ 3 months or at least 1 month if seroconversion occurred. Interviews were audio-recorded, transcribed into English, coded in Dedoose and thematically analyzed. Demographic and behavioral questionnaire data were summarized in Stata. Most AHA participants perceived the ring to be effective, and described simply trusting it or having confidence in it because they, or other participants in risky situations, remained HIV-uninfected. Participants described ring efficacy after receiving ASPIRE results as a binary assessment: the ring worked or not. Many did not remember exact efficacy percentages because of lack of comprehension or memory but recalled key details about age differences. The majority expressed interest in future ring use. There is a need to investigate improved ways of explaining placebo-controlled trials and efficacy to women in Sub-Saharan Africa. Now that ring efficacy, is known, these benefits must be well communicated, and understood by end-users and key stakeholders. Engagement with end-users to construct effective messages and to develop tools to measure understanding of partial efficacy will be essential., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Given sub-optimal HIV care outcomes for people living with HIV (PLWH) post-release from incarceration, we systematically searched peer-reviewed literature (2010-2021) describing controlled trial interventions aimed at improving Antiretroviral Therapy (ART) adherence and care linkage following release from correctional facilities for PLWH. Of 392 studies, 16 (4%) met the inclusion criteria. All studies were conducted in the United States and involved some form of intensive case management. Trials that scored highest in terms of study quality provided cell phones for engagement, reported sustained viral load suppression as a measurable outcome to infer ART adherence, and measured longitudinal data collected for at least 3-to-6 months following release. The two trials that demonstrated improved HIV viral load suppression involved Peer Navigators, and incentivized undetectable viral load, respectively. Facilitating support for addictions and addressing other social and structural barriers to achieving optimal health is also of vital importance in bridging care gaps for PLWH., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Long-acting injectable (LAI) modalities have been developed for ART and PrEP. Women face unique barriers to LAI use yet little research has examined women's perceptions of potential LAI HIV therapy candidates. We conducted 89 in-depth interviews at six Women's Interagency HIV Study (WIHS) sites with women living with HIV (n = 59) and HIV-negative women (n = 30) from 2017 to 2018. Interviews were recorded, transcribed, and analyzed using thematic content analysis. Participants identified specific sub-populations who could most benefit from LAI over daily pills: (1) young people; (2) women with childcare responsibilities; (3) people with adherence-related psychological distress; (4) individuals with multiple sex partners; and (5) people facing structural insecurities such as homelessness. Women are underserved by current HIV care options and their perspectives are imperative to ensure a successful scale-up of LAI PrEP and LAI ART that prioritizes equitable access and benefit for all individuals., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To examine whether type 2 diabetes mellitus (T2DM) is more common among women with HIV (WWH) than men with HIV (MWH)., Design: A cross-sectional analysis of a demographically heterogenous population-based sample of more than 64 million patients in the United States., Methods: Using the Explorys (IBM) database, compare the prevalence of T2DM among men and women without HIV and influence of HIV on T2DM by sex controlling for confounding factors., Results: From 19 182 775 persons included in the study, 39 485 were with HIV. Rates of obesity was higher among WWH than MWH (58 vs. 35%). Prevalence of T2DM among WWH was 23% compared with 16% among MWH (P < 0.001). In sex-stratified adjusted analysis, WWH had 1.31 [95% confidence interval (CI), 1.24-1.38] times the odds of having T2DM than women without HIV. Women with HIV was associated with T2DM across all demographic subgroups. In contrast, no association between HIV and T2DM was observed among men (OR 1.01; 95% CI 0.98-1.05)., Conclusion: These data suggest that HIV confers a sex-specific increase in odds of T2DM among women but not men., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose of Review: This paper provides a critical review of recent therapeutic advances in long-acting (LA) modalities for human immunodeficiency virus (HIV) treatment and prevention., Recent Findings: LA injectable antiretroviral therapy (ART) has been approved in the United States, Canada and Europe; the United States also has approved LA injectable preexposure prophylaxis (PrEP) and the World Health Organization has recommended the vaginal PrEP ring. Current LA PrEP modalities in clinical trials include injections, films, rings, and implants; LA ART modalities in trials include subcutaneous injections and long-term oral pills. Although LA modalities hold incredible promise, global availability is inhibited by long-standing multilevel perils including declining multilateral funding, patent protections and lack of political will. Once available, access and uptake are limited by factors such as insurance coverage, clinic access, labor markets, stigma, and structural racism and sexism. These must be addressed to facilitate equitable access for all., Summary: There have been tremendous recent advances in the efficacy of LA ART and PrEP modalities, providing renewed hope that 'ending the HIV epidemic' is within reach. However, pervasive socio-structural inequities limit the promise of LA modalities, highlighting the need for cautious optimism in light of the embedded inequities in the trajectory of research, development, and population-level implementation., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

The emergence of dual therapy for antiretroviral (ARV)-experienced persons living with HIV (PWH) offers the opportunity to reduce lifetime exposure to unnecessary ARV drugs while maintaining viral suppression and reducing the cost of care. Our objective, using retrospective analysis of a quality care initiative, was to examine in routine clinical practice the clinical impact of switching PWH stable on a three-drug to a two-drug single-tablet formulation (STF) ARV regimen. We also examined the cost implications of this STF adjustment. Between January 1, 2020 and January 1, 2021 eligible patients (i.e., virally suppressed, no active hepatitis B infection, no documented nucleoside reverse transcriptase inhibitors/integrase strand transfer inhibitor resistance) were offered, on a convenience basis and as part of routine care, the opportunity to adjust their current three-drug STF to a two-drug STF (dolutegarvair/lamivudine). The acceptance, clinical efficacy, safety, tolerability, and cost of treatment were measured for patients who switched in 2020. Of 989 eligible PWH, 408 were approached and 391 (39.5%) switched to two-drug regimen; 99% remained on the two-drug STF at year's end (median 240 days follow-up). Only 2/391 patients who switched lost viral control. The total ARV drug cost for all 989 patients decreased by 10.3% generating an actual savings of $1,596,666 among patients approached and switched in 2020. Patient interest and uptake in switching to two-drug STF was substantial and resulted in few discontinuations for any reason. It provided significant and immediate cost savings within the first year. Our results bring clarity to discussions on whether using two-drug regimens would be practical and acceptable in nonclinical trial settings.