Search

Pre-exposure prophylaxis (PrEP) is highly effective at reducing HIV acquisition. We aimed to estimate usage of oral-PrEP, and factors associated with adherence among female sex workers (FSWs) in Nairobi, Kenya, using a novel point-of-care urine tenofovir lateral flow assay (LFA). The Maisha Fiti study randomly selected FSWs from Sex Worker Outreach Program clinics in Nairobi. Data were collected from 1003 FSWs from June-October 2019, including surveys on self-reported oral-PrEP adherence. Adherence was also measured using the LFA for HIV-negative FSWs currently taking oral-PrEP. Informed by a social-ecological theoretical framework, we used hierarchical multivariable logistic regression models to estimate associations between individual, interpersonal/community, and structural/institutional-level factors and either self-reported or LFA-assessed adherence. Overall, 746 HIV-negative FSWs aged 18-40 participated in the study, of whom 180 (24.1%) self-reported currently taking oral-PrEP. Of these, 56 (31.1%) were adherent to oral-PrEP as measured by LFA. In the multivariable analyses, associations with currently taking oral-PrEP included having completed secondary education, high alcohol/substance use, feeling empowered to use PrEP, current intimate partner, no recent intimate partner violence, having support from sex worker organisations, experiencing sex work-related stigma, and seeking healthcare services despite stigma. Associations with oral-PrEP LFA-measured adherence measured included having only primary education, experience of childhood emotional violence, belonging to a higher wealth tertile, and being nulliparous. Oral-PrEP adherence, measured by self-report or objectively, is low among FSWs in Nairobi. Programs to improve oral-PrEP usage among FSWs should work to mitigate social and structural barriers and involve collaboration between FSWs, healthcare providers and policymakers.

BackgroundPre-exposure prophylaxis (PrEP) uptake remains low among people who could benefit, some of whom may prefer alternatives to oral PrEP, such as long-acting injectable pre-exposure prophylaxis (LAI-PrEP). We evaluated the potential for LAI-PrEP provision in pharmacies through a mixed methods study of pharmacists in California, where Senate Bill 159 enables pharmacists to independently provide oral PrEP.MethodsIn 2022-2023, we conducted an online cross-sectional survey of California pharmacists and pharmacy students (n = 919) and in-depth interviews with pharmacists (n = 30), both of which included modules assessing attitudes about PrEP provision. Using log-binomial regression, we estimated prevalence ratios (PRs) comparing survey participants' willingness to provide LAI-PrEP by pharmacy- and individual-level characteristics. Qualitative interview data were analyzed using Rapid Qualitative Analysis to identify factors that may affect pharmacists' provision of LAI-PrEP.ResultsHalf of the survey participants (53%) indicated that they would be willing to administer LAI-PrEP using gluteal injection in their pharmacy. Willingness was higher among participants who worked in pharmacies that provided vaccinations or other injections (56% vs. 46%; PR: 1.2; 95% confidence interval: 1.0-1.4) and/or oral PrEP under Senate Bill 159 (65% vs. 51%; PR: 1.3; 95% confidence interval: 1.1-1.5) than among participants whose pharmacies did not. Interviewed participants reported barriers to LAI-PrEP provision, including the need for increased training and staffing, a private room for gluteal injections, better medication access, and payment for services.ConclusionPharmacies offer a promising setting for increased LAI-PrEP access. However, pharmacists may require additional training, resources, and policy changes to make implementation feasible.

BackgroundLong-acting cabotegravir (CAB-LA) is highly effective for HIV prevention, but delayed HIV diagnoses and integrase strand transfer inhibitor (INSTI) resistance were observed in trials. We report the first case in routine clinical care of HIV infection on CAB-LA with INSTI resistance.MethodsThe SeroPrEP study enrolls individuals in the United States who acquire HIV on pre-exposure prophylaxis modalities to assess diagnostics, antiretroviral (ARV) drug levels, resistance, and treatment outcomes. Resistance mutations in full-length HIV-1 integrase were identified by single-genome sequencing (SGS). Cabotegravir concentrations in plasma and hair segments were measured by liquid chromatography-tandem mass spectrometry.ResultsA 23-year-old gender-nonbinary person, male at birth, restarted CAB-LA 6 months after discontinuation due to losing insurance. Prior to restart, HIV-1 RNA was not detected, but 20 days elapsed before CAB-LA injection. After the second CAB-LA injection, HIV antigen/antibody returned reactive (HIV-1 RNA 451 copies/mL). SGS of plasma HIV-1 RNA identified INSTI mutation Q148R in 2/24 sequences 2 days postdiagnosis; commercial genotype failed amplification. Cabotegravir hair concentration was 0.190 ng/mg 2 weeks prediagnosis; plasma cabotegravir was high (3.37 μg/mL; ∼20× PA-IC90) 14 days postdiagnosis. Viral suppression was maintained for 6 months on darunavir/cobicistat/emtricitabine/tenofovir alafenamide, then switched to doravirine + emtricitabine/tenofovir alafenamide due to nausea.ConclusionsIn this first case of HIV infection on CAB-LA with INSTI resistance in routine care, cabotegravir resistance was detected only with a sensitive research assay. Accelerated pathways to minimize time between HIV testing and CAB-LA initiation are needed to optimize acute HIV detection and mitigate resistance risk. Sustained product access regardless of insurance is imperative to reduce HIV infections on CAB-LA.

Mobile technology growth in Nepal offers promising opportunities for using mobile health (mHealth) interventions to facilitate HIV prevention efforts. However, little is known about access and utilization of communication technology and their willingness to use mHealth for HIV prevention services in Nepal. We conducted a cross-sectional respondent-driven sampling survey of 250 MSM in Kathmandu Valley of Nepal from October to December 2022. We collected information on participant characteristics, HIV risk-related behaviors, ownership, or access to and frequency of use of communication technology (phones, tablets, laptops, and computers), and willingness to use mHealth to access HIV prevention services. Descriptive, bivariate, and multivariate linear regression analyses were performed. Almost all participants had smartphones with the internet (231/250, 92.4%) and accessed the internet daily (219/250, 87.6%) on the smartphone (236/250, 94.4%). The median score for willingness to use mHealth for HIV prevention was 10 (IQR: 3 to 17). Willingness to use mHealth was higher among those participants with a high school or above education (β = 0.223, p = < 0.001), had experienced violence (β = 0.231, p = 0.006), and had moderate to severe depressive symptoms (β = 0.223, p = < 0.001). However, monthly income above NPR 20,000 (USD 150) (β= -0.153, p = 0.008), disclosure of their sexual orientation to anyone (β= -0.159, p = < 0.007), and worry about being negatively judged by health care workers (β= -0.136, p = 0.023) were less willing to use mHealth strategies. The findings from this study suggest that there is a high willingness for utilizing mHealth interventions for HIV prevention in MSM population who are at higher risk of HIV acquisition.

INTRODUCTION: Post-exposure prophylaxis (PEP) is an efficacious prevention method when initiated promptly after an HIV exposure. Yet, PEP has been underutilized, even among healthcare workers (HCWs) with occupational exposure in sites with PEP policies and procedures and access to PEP medications. It is important to understand the dynamics of uneven PEP use in what appears to be an optimal context to better protect the health and wellbeing of HCWs. METHODS: We conducted a scoping review to elucidate factors influencing HCWs use of PEP after occupational exposure. We searched PubMed, PsychInfo and Google Scholar for peer-reviewed literature published in English from 2014 to 2022 using the terms HIV, postexposure/post-exposure prophylaxis, acceptability, healthcare workers, and values and preferences. An inductive narrative review of the resulting 53 studies identified core themes. RESULTS: Nearly all studies (96%) with various HCW types and settings occurred in low- and middle-income countries (LMICs) in Africa and Asia. Identified themes arrayed along a trajectory of PEP use experience: awareness/knowledge; acceptability; availability/access; uptake/use; adherence/completion. Across studies, awareness of PEP for HIV prevention was high, knowledge about drug regimens and healthcare facility policies was moderate to low; acceptability of PEP was moderate to high; PEPs perceived accessibility/availability was inconsistent and varied by geographic location and setting; HCWs uptake of PEP was low, affected by not knowing how to report an exposure and being unaware of PEP availability; and adherence/completion of PEP regimens was moderate to low, impeded by side effects and a belief that completing regimens was unnecessary to avert seroconversion. HCWs consistently expressed concern about HIV stigma. DISCUSSION: Findings are limited by the inconsistent use of constructs across studies and a lack of clarity about reporting exposure events. Multi-level approaches are needed to address the interplay of individual, social and structural barriers that diminish HCWs PEP use. Improved training, incident reporting, 24-hour access to non-stigmatizing PEP services and monitoring of adherence/completion are essential to optimizing HCWs PEP use. CONCLUSIONS: Lessons from HCWs experience in LMICs may inform understanding of PEP under-use among people in these settings with non-occupational exposures.

BACKGROUND: Safer conception services are needed to minimize HIV transmission among HIV sero-discordant couples desiring pregnancy. Few studies have evaluated the choices couples make when they are offered multiple safer conception methods or real-world method acceptability. This paper addresses an important knowledge gap regarding factors that influence the choice of safer conception methods, couples actual experiences using safer conception methods, and why some couples switch safer conception methods. METHODS: Between February and June 2019, we conducted semi-structured in-depth interviews among 14 men and 17 women, representing 17 couples who exited the SAFER study-a pilot safer conception study for HIV sero-discordant couples in Zimbabwe that offered couples a choice of ART with monthly viral load monitoring (ART/VL), oral PrEP, vaginal insemination, and semen washing. All couples in SAFER had used at least two safer conception methods. RESULTS: We found that safer conception method choice often centered around a desire for intimacy, condomless sex, and certainty in the conception process, particularly for men. Method-related attributes such as familiarity, perceived ease of use, side effects, and perceived level of effectiveness in preventing HIV and achieving pregnancy influenced method choice, switching, and satisfaction. Concerns were expressed about each safer conception method and couples were willing to try different methods until they found method(s) that worked for them. The majority of participants reported having positive experiences using safer conception, especially those using ART/VL + PrEP, citing that they were able to attempt pregnancy for the first time with peace of mind and experienced joy and satisfaction from being able to achieve pregnancy safely. CONCLUSIONS: The differences in method preferences and experiences voiced by participants in this study and in other studies from the region point to the importance of having a variety of safer conception options in the service delivery package and addressing concerns about paternity, intimacy, and method-related attributes to enable HIV sero-discordant couples to safely achieve their reproductive goals.

To estimate the effect of neighborhood-level modification on the efficacy of the MyPEEPS Mobile intervention on the reduction of condomless anal sex acts among same-sex attracted adolescent men. A series of generalized linear mixed model was used to examine if the effect of the MyPEEPS Mobile intervention on condomless anal sex acts was moderated by neighborhood-level factors using data from the 2019 American Community Survey US Census Bureau. The magnitudes of intervention were significantly smaller at both 6- and 9-month follow-up among adolescents living in neighborhood with high proportions of Hispanic or Latino residents (IRR6M = 1.02, 95 % CI: 1.01, 1.02; IRR9M = 1.03, 95 % CI: 1.01, 1.05) and high proportions of families with income below the poverty level (IRR6M = 1.07, 95 % CI: 1.01, 1.12; IRR9M = 1.05, 95 % CI: 1.01, 1.10), which indicated that living in communities with a higher concentration of residents living under poverty or of Hispanic/and Latino ethnicity significantly modified the effective of program intervention on condomless sex among adolescent MSM. Understanding how neighborhood characteristics modify the effect of HIV prevention interventions may be useful in better targeting delivery and tailoring content of interventions based on neighborhood level characteristics such as the ones identified in this study.

IntroductionHPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial.MethodsParticipants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non-adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis.ResultsParticipants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules).ConclusionsRespondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non-judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.

BackgroundDespite high rates of HIV transmission among men who have sex with men (MSM) in Lima, Peru, limited data exist on the sexual network characteristics or risk factors for secondary HIV transmission among MSM with uncontrolled HIV infection. We report the frequency of serodiscordant, condomless anal intercourse (CAI) and associated sexual network characteristics among MSM in Lima with detectable HIV viremia and compare to those with undetectable viremia.MethodsThis cross-sectional analysis includes MSM who tested positive for HIV-1 during screening for a trial of partner management and STI control (June 2022-January 2023). Participants were tested for HIV, gonorrhoea, chlamydia, and syphilis, and completed questionnaires on their demographic characteristics, sexual identity and behaviour, sexual network structures and engagement in HIV care.FindingsOf 665 MSM, 153 (23%) had detectable (>200 copies/mL) viremia. 75% (499/662) of men living with HIV were previously diagnosed, with 94% (n = 469/499) reporting that they were on ART, and 93% (n = 436/469) virally suppressed. 96% (n = 147/153) of men with detectable viremia reported serodiscordant CAI with at least one of their last three sexual partners, and 74% (n = 106/144) reported the same with all three of their recent partners. In contrast, 62% (n = 302/489) of men with undetectable viral load reported serodiscordant CAI with all of their last three partners (p

The Microbicide Trials Network 042 study (MTN-042/DELIVER) is a two-arm, randomized, open-label Phase 3b trial that is evaluating the safety, adherence, and acceptability of the monthly ring and daily oral PrEP among HIV-uninfected pregnant people in four African countries. This analysis focuses on acceptability data captured qualitatively from a subset (n = 48) of the 150 people in the first cohort of the trial who were enrolled in late-stage pregnancy at 36 to 38 weeks gestational age and followed until after delivery. Single IDIs were conducted by trained interviewers at each clinic site using a semi-structured guide. Data excerpts of key codes pertaining to acceptability, pregnancy, and maternal health were summarized, reviewed and interpreted by multinational analyst teams. Although the product use period was relatively short, the data suggested several acceptability findings that may directly translate to longer durations of product use in pregnancy. The first was the overarching maternal sentiment that being able to protect both oneself and their baby was highly valued. The second was the importance of counseling support from providers not only because participants used methods that might generate side effects, but because pregnancy itself is a period with its own set of side effects. The third was that, similar to non-pregnant participants in other trials, here study products were generally liked and described as easy to use. Concerns about ring and oral PrEP use could be addressed with provider counseling and support and should form an essential component rollout among pregnant people.

The article discusses the importance of public health expertise in Ecuadorian health leadership, highlighting the need for ministers of health to have advanced degrees in public health to effectively address the nation's health challenges. It analyzes the impact of different health ministers on infant mortality rates in Ecuador from 1998 to 2024, emphasizing the importance of evidence-based leadership in improving public health outcomes. The article also addresses issues of corruption, mismanagement, and the lack of public health expertise during the COVID-19 pandemic, underscoring the need for competent and skilled health leaders to drive sustainable health improvements in Ecuador. [Extracted from the article]

Background: Women involved in the criminal legal system have elevated rates of opioid use disorder, which is treatable, and HIV, which is preventable with pre-exposure prophylaxis (PrEP). There are significant social and structural barriers to integrated delivery of PrEP and medications for opioid use disorder (MOUD), limiting women's ability to access these life-saving interventions. In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD and is tailored to meet the specific needs of women involved in the criminal legal system. Methods: We will recruit and enroll 250 women involved in the criminal legal system with opioid use disorder across two diverse settings (New Haven, CT and Birmingham, AL). Participants will be randomized to (a) the "Athena strategy," which includes a PrEP decision aid and integrated PrEP/MOUD delivery via eHealth; or (b) enhanced standard of care (SOC) that includes a decision aid-only. During 6-month follow-up, we will assess PrEP initiation as the primary clinical outcome and implementation outcomes that include acceptability, adoption, feasibility, fidelity, implementation cost, and sustainability. Discussion: Results could help determine if reducing the social and structural barriers to PrEP and MOUD for women involved in the criminal legal system will facilitate engagement in treatment and prevention services, thus alleviating health disparities. Trial registration: Clinicaltrials.gov (NCT05547048). Registered September 15, 2022. https://clinicaltrials.gov/study/NCT05547048?term=NCT05547048&rank=1. [ABSTRACT FROM AUTHOR]

Background: Female sex workers (FSWs) have the highest HIV prevalence in Uganda. Pre-exposure prophylaxis (PrEP) has been recommended as a key component of the HIV combination prevention strategy. Although patient initiation of PrEP has improved, continuation rates remain low. This study evaluated PrEP continuation among FSWs and explored potential determinants of PrEP adherence within a public referral hospital in urban Uganda. Methods: We conducted an explanatory sequential mixed method study at Kiruddu National referral hospital in Uganda. Secondary data on socio demographic characteristics and follow up outcomes of at least one year was collected for all FSWs who were initiated PrEP between May 2020 and April 2021 and data analyzed on July 15,2023. We used Kaplan–Meier survival analysis to evaluate continuation on PrEP from time of initiation and follow-up period. The capability, opportunity, and motivation to change behaviour model was used to explore perspectives and practices of FSWs (n = 24) and health care providers (n = 8) on continuation on PrEP among FSWs, using semi structured interviews. The qualitative data was deductively coded and analyzed thematically, categorizing the themes related to PrEP continuation as facilitators and barriers. Results: Of the 292 FSWs initiated on PrEP, median age was 26 years (interquartile range, 21–29), 101 (34.6) % were active on PrEP, 137 (46.9%) were lost to follow-up, 45 (15.4%) were no longer eligible to continue PrEP, eight (2.7%) were transferred out and one (0.3%) had died. Median survival time on PrEP was 15 months (Interquartile range IQR, 3–21). The continuation rates on PrEP at six (6) and 12 months were 61.1% and 53.1%, respectively. Facilitators of PrEP continuation included awareness of risk associated with sex work, integration of PrEP with other HIV prevention services, presence of PrEP Peer support and use of Drop-in centers. The barriers included low community awareness about PrEP, high mobility of sex workers, substance abuse, and the unfavorable daytime clinic schedules. However, the quantitative findings from the multivariable Cox Proportional Hazards Model did not align with the reported findings for the qualitative evaluation. Conclusion: Continuation on PrEP remains low among FSWs. Interventions for PrEP continuation should address barriers such as low community awareness of PrEP, substance abuse and restrictive health facility policies for scale of the PrEP program among FSWs in Uganda. Integration of PrEP with other services and scale up of community PrEP delivery structures may improve its continuation. [ABSTRACT FROM AUTHOR]

End-user feedback early in product development is important for optimizing multipurpose prevention technologies for HIV and pregnancy prevention. We evaluated the acceptability of the 90-day dapivirine levonorgestrel ring (DPV-LNG ring) used for 14 days compared to a dapivirine-only ring (DVR-200mg) in MTN-030/IPM 041 (n = 23), and when used for 90 days cyclically or continuously in MTN-044/IPM 053/CCN019 (n = 25). We enrolled healthy, non-pregnant, HIV-negative women aged 18–45 in Pittsburgh, PA and Birmingham, AL (MTN-030 only). Self-reports of vaginal bleeding and adherence (ring removals, expulsions) were collected via daily short message service. Acceptability data were recorded in face-to-face interviews at study exit. We assessed differences in acceptability by product characteristics and adherence; and associations between baseline characteristics/demographics, number of bleeding days, adherence, and overall acceptability. Most (21/23) women in the 14-day MTN-030 study and about half (13/25) in the 90-day MTN-044 study liked their assigned rings. In MTN-030 there were no significant associations between any variables and overall acceptability of either ring. In MTN-044, women who disliked the DPV-LNG ring had a significantly higher incidence of unanticipated vaginal bleeding, and reporting that vaginal bleeding changes were unacceptable than those who liked it. Although we found no overall association between adherence and acceptability, significantly more women who disliked (versus liked) the DPV-LNG ring reported expulsions during toileting. The DPV-LNG ring could meet the needs of women seeking simultaneous protection from HIV and unintended pregnancy. Addressing issues related to vaginal bleeding and expulsions early in product development will likely enhance acceptability of the DPV-LNG ring. Trial registration: Clinical Trial Registration: MTN-030/IPM 041: ClinicalTrials.gov NCT02855346; MTN-044/IPM 053/CCN019: ClinicalTrials.gov NCT03467347. [ABSTRACT FROM AUTHOR]

This study addresses disparities among people with a migration background (PMB) and those in less-urban regions, across the HIV prevention and care continuum (HIVPCC). We conducted a needs assessment and assets assessment to identify gaps between existing initiatives and persisting barriers. The research was conducted in the Euregio Meuse-Rhine (EMR), encompassing bordering regions in Belgium, Germany, and the Netherlands, and involved in-depth interviews with fifteen first-generation PMB, including nine with HIV. Six factors influencing PMB access to the HIVPCC were identified: past experiences with sexually transmitted infections (STIs) or HIV; HIV stigma and social dynamics; confidence and communication with healthcare providers and social workers; healthcare system navigation; precarity; and knowledge and beliefs about HIV/STIs. Existing assets mostly target individual or interpersonal levels, are often inaccessible due to language barriers, inadequately match PMB’s living conditions and culture, and are irregular and hyperlocal. Recommendations include enhancing cultural sensitivity, adopting participatory approaches, tailoring outreach activities to legal situations and cultural context, and fostering cooperation between healthcare and social work institutions. This study underscores the importance of considering societal and institutional dynamics in bridging gaps in the HIVPCC for PMB, advocating for targeted interventions that promote inclusivity and equity. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP) has emerged as a prominent approach for the prevention of HIV infections. While the latest advances have resulted in effective oral and injectable product options, there are still gaps in on-demand, event-driven, topical products for HIV prevention that are safe and effective. Here we describe the formulation development of a dual-compartment topical insert containing tenofovir alafenamide fumarate (TAF) and elvitegravir (EVG) that may be administered when needed, vaginally or rectally, pre- or post-coitus, for flexible HIV prophylaxis. Specifically, we describe the lab-scale formulation development, preclinical mucosal safety and pharmacokinetics (PK) testing in rabbits, long-term stability, and scale-up clinical manufacturing of the lead TAF/EVG (20 mg/16 mg) inserts, which are currently in clinical stages of development. As designed, the inserts are small, discreet and portable, offering a number of promising attributes, such as simple and robust direct-compression manufacturing, fast initial disintegration/dissolution, and suitable mechanical strengths showing low hardness (<8 kg), friability (<1 %), and moisture content (<1 %). The inserts initiated disintegration quickly (∼ ≤ 15 min) providing full in vitro release (>90 %) of TAF and EVG within 60 min of dissolution. The lead insert was selected from formulation prototypes that met the evaluation criteria for manufacturability and characterization, along with a dose-ranging PK study in non-human primates. Successful technology transfer for clinical development of the lead TAF/EVG (20 mg/16 mg) insert was confirmed under current Good Manufacturing Practices (cGMP) conditions. Based on the 12 months (lab-scale) and 24 months (clinical batch) stability data, the TAF/EVG inserts are projected to have a long shelf life of over 2 years, if stored at or below 30 °C/65 % RH. Overall, these newly designed topical inserts have formulation properties that enable stable storage and fast release of the antiretroviral payload from a small, portable and discreet dosage form. They are safe and effective when applied vaginally or rectally, before or after coitus, providing the basis for a new method of flexible on-demand HIV prevention for cisgender and transgender women and men. The TAF/EVG inserts are currently the most clinically advanced on-demand topical product, as attested by their completed and ongoing clinical trials. [Display omitted] • Lab-scale formulation development through technology transfer, scale-up and clinical batch manufacturing of TAF/EVG inserts • TAF/EVG inserts provide fast drug release, allowing for flexible pre- or post-exposure HIV prophylaxis • Repeated vaginal/rectal dosing in rabbits resulted in no safety concerns, high drug tissue levels, and low systemic exposure • The inserts are projected to have a long shelf life of more than two years if stored at or below 30 °C/65 % RH [ABSTRACT FROM AUTHOR]

Background: Increased risk of HIV acquisition during pregnancy and lactation among women is evident, necessitating their inclusion in the evaluation of new HIV prevention interventions. Pregnant and postpartum women specifically face challenges with oral PrEP associated with stigma, and the burden of using other tablets. Long-acting products may address challenges related to oral PrEP, however, there is limited data on product-specific preferences and acceptability among pregnant and lactating women. Methods: We conducted a mixed-method study to assess the preferences and acceptability of long-acting PrEP modalities either under development or already established among pregnant and lactating women. We conducted quantitative surveys (n = 434) and in-depth interviews (n = 80) in central and western Kenya. We used descriptive statistics and categorical variables to summarize frequencies and proportions. Inductive and deductive content analytic approaches were used for in-depth interviews. Results: The median age of respondents was 25 years (IQR 19.3–31.0). Majority were married (263/434, 61%), had completed high school (222/434, 51%), with no condoms use in the prior 3 months (348/434, 80%). The most preferred PrEP formulations were injectable (251/434, 57%) and implantable (175/434, 40%) options. Participants who preferred injectable PrEP had 8.56 times higher odds of considering ease of use as a reason. (aOR = 8.56, 95% CI [3.81–20.48]) and 3.71 odds of choosing perceived discreteness (aOR = 3.71, 95% CI (1.57–9.97)) as their preference reasons. Participants who preferred Implant for HIV prevention had 2.31 odds of considering it due to perceived effectiveness in preventing HIV as a preference reason (aOR = 2.31, 95% CI (1.21—4.66)) and 2.53-fold of considering discreteness as a preference reason (aOR = 2.53, 95% CI (1.46—4.59)). From the in-depth interviews, women reported prospective acceptability due to the perceived convenience of LA products, perceived effectiveness, reduced cost, improved privacy, and reduced stigma. Women had concerns regarding the safety and efficacy of the products during pregnancy and lactation. Conclusion: Acceptability of LA products underscores the importance of considering the unique needs of pregnant and breastfeeding women in the development of future prevention interventions. Aligning preferences and needs would enhance the uptake and adherence outcomes of HIV prevention products. [ABSTRACT FROM AUTHOR]

Background Pre-exposure prophylaxis (PrEP) is effective for human immunodeficiency virus (HIV) prevention in risk groups. We assessed PrEP uptake and 12-month retention among men who have sex with men (MSM) and transgender women (TGW) in Myanmar during the coronavirus disease 2019 pandemic and a political crisis. Methods Using prospectively collected data, we assessed the proportion of persons eligible, initiated and retained 12 months on PrEP. We calculated HIV and syphilis incidence among those initiated on PrEP. Predictors of compliance to scheduled visits were assessed with fractional logistic regression. Results Among 652 persons screened between July and December 2020, 85.3% were eligible and 38.8% initiated PrEP. The daily pill burden was the main reason (86.5%) for refusing PrEP. A history of HIV post-exposure prophylaxis (PEP) and having an HIV-positive partner not on anti-retroviral therapy (ART) was associated with PrEP uptake (p<0.05). The 12-month retention among those initiating PrEP was 43.0%. Age ≥25 y, a history of PEP and having an HIV-positive partner not on ART predicted better compliance with scheduled visits (p<0.05). HIV incidence among PrEP initiators was 3.1 per 100 person-years (95% confidence interval [CI] 1.3 to 7.4) and syphilis incidence was 17.6 per 100 person-years (95% CI 12.3 to 25.1). Conclusions A PrEP program for MSM and TGW in Myanmar was implemented successfully under difficult circumstances. Alternative strategies are needed addressing PrEP uptake and retention. [ABSTRACT FROM AUTHOR]

Although literature regarding HIV prevention among transgender and nonbinary (TNB) people has grown considerably, important gaps remain, particularly in relation to the HIV pre-exposure prophylaxis (PrEP) care cascade. Additional research is needed to understand when and why TNB people exit the PrEP care cascade to inform interventions to better support these populations. Moreover, most studies have focused on transgender women, though transgender men and nonbinary people also experience a disproportionate prevalence of HIV relative to cisgender populations. This study addresses these gaps by exploring engagement in the PrEP care cascade among a statewide convenience sample of 659 transgender women, transgender men, and nonbinary people, and analyzing how gender identity impacts participant likelihood to continue along the cascade. Data come from the 2018 Michigan Trans Health Study and include self-report data on demographics, sexual behavior, and PrEP awareness, information receipt, referral, initiation, and retention. Participants who self-reported vaginal/front hole or anal sex and did not use barriers (n = 318) were considered eligible for PrEP. Only 21.13% of those eligible for PrEP received information about PrEP, 8.18% were referred to PrEP, and 1.57% initiated PrEP use. A significantly greater proportion of transfeminine and participants who identified with multiple/other genders reported receiving PrEP information than those who identified as transmasculine or nonbinary [χ2 (3, n = 311) =11.34, p =.01]. No other significant gender differences were observed. Providers serving TNB individuals must recognize the diversity of individuals who qualify for information on PrEP, provide trans-affirming care when offering PrEP prescriptions, and consider situating PrEP opportunities in TNB serving spaces to reduce access barriers. [ABSTRACT FROM AUTHOR]

Reproductive health significantly contributes to the overall well-being and social welfare of women. Within the spectrum of modern and traditional contraceptive methods in use, condoms have been strongly advocated by numerous HIV programs as a primary means of preventing HIV infection in Sri Lanka. Given the intrinsic relationship between contraceptive utilization and HIV awareness, our study aims to concurrently analyze the patterns of contraceptive usage and HIV knowledge, while accounting for their potential correlation. In this study, we introduced the application of the Gumbel type II distribution to effectively capture the interdependence of these joint probabilities, accounting for various covariates. The outcome of simulation studies demonstrated the superior performance of the integrated joint model, in comparison to the separate univariate models. Our findings highlighted several noteworthy risk factors associated with both contraceptive usage and HIV prevention knowledge. These included variables such as residence, level of education, wealth quintile, husband's education level, number of children, engagement with the newspapers, television viewership, and mobile phone usage. The Result indicates a positive association between the adoption of contraception and the awareness of HIV prevention measures, suggesting that individuals who actively embrace contraception are more likely to possess knowledge about preventing HIV transmission. [ABSTRACT FROM AUTHOR]

New Human Immunodeficiency Virus (HIV) cases continue to disproportionately burden cisgender Black/African American women in the United States due to a confluence of structural and systemic factors. Pre-exposure prophylaxis (PrEP) is a safe and effective HIV prevention option, yet there is a striking gap between PrEP eligibility and uptake among cisgender Black women. The current study evaluates a novel warm handoff process in a hospital emergency department setting linking eligible women to local PrEP clinics within 72 hours of hospital discharge in a large southwestern metropolitan city. Participants received follow-up telephone consultations at 1-month (T1), 3-months (T2), and 6-months (T3) post-enrollment. Of 40 participants, one was successfully linked to their initial PrEP clinic visit. One additional participant reported attending their PrEP visit, but staff were unable to confirm linkage. Twenty-eight percent of participants attended follow-up telephone visits at T1, T2, and T3, while 35% of participants attended a combination of some, and 37% of participants did not engage in any follow-up visits. Findings suggest that culturally tailored linkage interventions are suitable mechanisms for engaging cisgender Black women in PrEP care. Implications for future research include exploring the sustainability and scalability of such interventions are discussed. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP) dramatically reduces HIV transmission risk. PrEP is underutilized among men who have sex with men who use substances (SU-MSM) in the Southern U.S., for whom there is limited research and high PrEP need. Using cross-sectional data from the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) 0082 study, we explored factors associated with PrEP awareness and use among 225 SU-MSM in the Southern U.S. Participants were recruited from community-based sexually transmitted infection clinics, syringe services programs and outpatient substance use treatment programs in eight cities across five Southern states with high HIV incidence. Multinomial logistic regressions examined PrEP awareness and use relative to sociodemographic factors, sexual behaviors and substance use. Results demonstrated overall high awareness, yet limited uptake of PrEP. Younger age, higher education, condomless anal sex and more frequent popper use were associated with greater odds of PrEP awareness. Higher education, condomless anal sex and more frequent popper use were associated with greater odds of PrEP use. Results highlight the need for innovative PrEP outreach to Southern SU-MSM that accounts for age, education and substances used. [ABSTRACT FROM AUTHOR]

HIV PrEP is over 99% effective in preventing HIV when medication adherence is high. Despite this, uptake and retention in PrEP care remains less than optimal. We investigated whether gbMSM with objective risk factors for HIV who were automatically offered PrEP would have higher uptake and retention in PrEP care. For this, gbMSM with clinical evidence of HIV risk received a reflexive offer for PrEP from a nurse. The number of offers, referral acceptance, presentation to the first appointment, initiation and retention at 6 months were examined. Of 1181 gbMSM with objective HIV risk factors who were offered PrEP, only 50% accepted, 28% initiated and 16% remained on PrEP at 6 months. Loss across the cascade was more pronounced for youth. We found a notable disconnect between recent STI diagnosis and acceptance, initiation and retention in PrEP. This notwithstanding, 137 at-risk individuals were retained on PrEP because of an active offer. PrEP delivered by nurses was as effective as that delivered by infectious disease physicians. While active offer PrEP successfully brought at-risk individuals into care, more work is required to understand the perceptions of risk, the benefits and challenges of PrEP use, and how stigma and structural barriers affect retention among diverse groups affected by HIV. [ABSTRACT FROM AUTHOR]

The potential of peers to be effective in delivering HIV interventions is linked at least in part to the degree to which they are perceived as credible sources of HIV-related information. This study aimed to operationalize qualities that would make a LMSM peer implementer credible. We conducted a qualitative analysis of semi-structured interviews with 20 LMSM and focus groups with 11 HIV service implementers. The parent study collected formative data to inform the design of a strategy to enhance the reach of HIV prevention and treatment services to LMSM. The present study examined participant views on qualities necessary for peer implementers to establish credibility among LMSM. We identified five themes regarding peer credibility, including (1) Peers must be trained in HIV prevention and care, (2) Peers should be verified and have a special designation indicating their knowledge and trustworthiness, (3) Peers should convey accurate information and not spread misinformation, (4) Peers should be relatable and interpersonally skilled, and (5) Peers should be engaged with the general LGBTQ + community to generate trust and credibility. Findings can inform the development of acceptable peer strategies for LMSM, peer recruitment, training, and peer supervision. [ABSTRACT FROM AUTHOR]

The high prevalence of trauma among people with HIV (PWH) and its negative impact on HIV outcomes underscore the need for Ryan White-funded HIV clinics (RWCs) to implement trauma-informed care (TIC) inclusive of crisis prevention and response. As part of a mixed-methods study of TIC practices employed by RWCs, we conducted qualitative interviews with 36 administrators, providers, and staff from Southeastern RWCs exploring crisis prevention and response strategies. Interviews were guided by the Substance Abuse and Mental Health Services Administration TIC framework and analyzed using a framework-driven, qualitative thematic approach. Crisis prevention strategies included: using electronic medical records to identify patients at risk for experiencing crisis, peer navigators to help patients bypass clinic public spaces, protocols to ensure perpetrator-victim pairs were not concurrently scheduled, and social workers to help patients identify crisis triggers and develop safety plans, plus dedicating safe spaces for patients with extensive trauma histories. Crisis response included patient referral to onsite and community crisis intake, trauma support, and mental health services and having onsite security personnel and alarm systems. Several participants requested additional training in response protocols. Study findings highlight the need for RW network-wide TIC training and sharing of best practices in crisis prevention and response. [ABSTRACT FROM AUTHOR]

Latino men, especially Latino men who have sex with men (LMSM), experience disparities in HIV prevention. Lack of attention to key barriers to care, such as stigma, result in inequitable access to HIV prevention and care for LMSM. This paper describes how intersectional stigma and related factors act as barriers to HIV prevention among Latino men and proposes strategies to overcome these barriers. Qualitative data were collected via in-depth interviews (n = 15) with Latino men about HIV prevention services, mobile outreach, peer navigation and care coordination, and analyzed using rapid qualitative methods. Three key themes emerged: (1) HIV stigma as a barrier to HIV testing, (2) sexual minority stigma as a barrier to accessing HIV prevention services and (3) strategies for stigma reduction, such as confidentiality, comprehensive education about HIV and prevention, and empathy and warmth from staff/care providers. Identified stigmas were intersectional. Addressing and reducing stigma is critical to engaging Latino men in HIV prevention and care, and requires strategies sensitive to the Latino cultural context and community. [ABSTRACT FROM AUTHOR]

Syndemic theory proposes that co-occurring, mutually reinforcing psychosocial challenges (mental health, substance use, minority stress [discrimination/stigma], abuse, unmet basic needs) drive HIV risk behavior and create barriers to care for marginalized populations. It is thus necessary to address this holistic, complex picture in HIV prevention. Emergency department (ED) visits are a prime opportunity to engage key risk groups, given their low engagement in regular clinic-based care and high utilization of drop-in care via EDs. Yet, EDs are overburdened and under-resourced; mHealth may be a vehicle for intervention delivery in this context. This study aimed to 1) characterize demographics, syndemic profiles, and HIV risk behavior among ED patients and 2) assess the acceptability of addressing syndemic issues, particularly via an mHealth approach, in the ED. A sample of N = 198 ED patients with an indication of HIV risk completed a cross-sectional psychosocial assessment. Descriptive statistics and bivariate correlations between syndemic issues were examined. Patients presenting to the ED reported marginalized identities and complex syndemic profiles including mental health issues (77%), at risk substance use (30%), childhood abuse (35%), adult abuse (31%), minority stress (63%), and unmet basic needs (37%). Over half the sample reported at least three syndemic issues (54%). All syndemic issues were significantly correlated with each other, supporting a synergistic nature. The sample reported indicators of HIV risk including lack of PrEP awareness (33%)/uptake (94%), condomless sex (37%), and not testing for HIV (41%). Majority reported syndemic profiles have never been addressed in the ED (71%), think it would be helpful (88%), and willing to utilize mHealth during an ED visit (76%). The current study provides information to guide next steps for ED-based point-of-care HIV prevention, and more broadly, working towards equitable HIV prevention services reaching those missed by existing interventions. [ABSTRACT FROM AUTHOR]

Long-acting injectable pre-exposure prophylaxis for HIV prevention (LAI-PrEP) was approved for use in the United States in 2021, yet little is known about perceptions of LAI-PrEP among transgender and nonbinary young adults, a group that faces substantial barriers to HIV prevention. We investigated US transgender and nonbinary young adults' perceptions of and attitudes toward LAI-PrEP and how perceived advantages and disadvantages of LAI-PrEP related to the PrEP continuum of care. We conducted semi-structured interviews with 31 transgender and nonbinary young adults who reported oral PrEP use or were PrEP-eligible. We analyzed responses using both a deductive RADaR approach, to identify LAI-PrEP perceptions relevant to the PrEP continuum of care, and an inductive thematic analysis to explore key themes. In this study, all PrEP-experienced and most PrEP-naïve participants indicated an interest in LAI-PrEP, citing advantages over daily oral medication (e.g., fewer adherence challenges). Three key themes emerged: (1) Some participants linked perceived advantages of LAI-PrEP to experiences with gender-affirming care (e.g., familiarity with needles via hormone use). (2) Participants weighed trade-offs and contextual factors that influenced their LAI-PrEP preferences (e.g., interest contingent on whether location for receiving injection was geographically accessible). (3) Participants envisaged alternative delivery methods that could enhance LAI-PrEP acceptability and uptake (e.g., home injection). HIV prevention programs should incorporate the insights of transgender and nonbinary young adults to ensure that emerging HIV prevention technologies are accessible and responsive to the needs and concerns of people of all gender modalities. [ABSTRACT FROM AUTHOR]

Heterosexuals have become the most prevalent group of HIV-1 in Kunming, Yunnan Province. Utilizing the principle of genetic similarity between their gene sequences, we built a molecular transmission network by gathering data from earlier molecular epidemiological studies. This allowed us to analyze the epidemiological features of this group and offer fresh concepts and approaches for the prevention and management of HIV-1 epidemics. Cytoscope was used to visualize and characterize the network following the processing of the sample gene sequences by BioEdit and HyPhy. The number of possible links and the size of the clusters were investigated as influencing factors using a zero-inflated Poisson model and a logistic regression model, respectively. A scikit-learn-based prediction model was developed to account for the dynamic changes in the HIV-1 molecular network. Six noteworthy modular clusters with network scores ranging from 4 to 9 were found from 150 clusters using Molecular Complex Detection analysis at a standard genetic distance threshold of 0.01. The size of the number of possible links and the network's clustering rate were significantly impacted by sampling time, marital status, and CD4+ T lymphocytes (all p < 0.05). The gradient boosting machine (GBM) model had the highest area under the curve value, 0.884 ± 0.051, according to scikit-learn. Though not all cluster subtypes grew equally, the network clusters were relatively specific and aggregated. The largest local transmission-risk group for HIV-1CRF08_BC is now the heterosexual transmission population. The most suitable model for constructing the HIV-1 molecular network dynamics prediction model was found to be the GBM model. [ABSTRACT FROM AUTHOR]

We examined the role of network communication about HIV-related topics in mediating the efficacy of a social network intervention on HIV seroconversion among people who inject drugs (PWID) in Ukraine, where Eastern Europe's second-largest HIV epidemic is concentrated among PWID. We used randomized controlled trial data from 1200 HIV-negative PWID (Ukraine; 2010–2012) in an inverse-odds weighted analysis to examine mediation by network communication. Network communication mediated 24 % (95 % CI= 19.22–29.38) of the intervention's effect. Integrating training to support network communication about additional HIV prevention resources could enhance the impact of social network HIV prevention interventions among PWID. • We assessed a mechanism through which a social network intervention reduced HIV seroconversion among PWID. • Network communication about HIV risk reduction mediated 24 % of the intervention's effect. • Our findings support increasing communication about HIV risk reduction in social networks of PWID. • Leveraging existing social networks could impact HIV harm reduction among PWID. [ABSTRACT FROM AUTHOR]

The availability of several HIV prevention options may allow women to choose a product that suits their lifestyle and preferences. Product attributes and contextual factors influence product acceptability, which affects uptake and effective use. We conducted a systematic review of acceptability and preference for biomedical HIV prevention products among women in sub-Saharan Africa (SSA) to inform the development of novel products. We used a comprehensive strategy to search three databases for peer-reviewed literature from SSA published between January 2015 and December 2023. A two-stage review process assessed references against eligibility criteria. Data were abstracted using a standardized spreadsheet, then organized by constructs from two theoretical frameworks of acceptability. Results were synthesized based on product classes defined by route of administration. We identified 408 unique references; 100 references met eligibility criteria. References assessed oral PrEP (n = 65), vaginal ring (n = 44), long-acting systemic products (injectable, implant, microarray patch) (n = 28), and other vaginal products (film, insert, gel) (n = 20). Over two-thirds reported qualitative or mixed-methods data, primarily from adolescent girls and young women. Frequent dosing, especially noted for daily oral PrEP, and perceived/experienced side effects were notably negative influences. Most end-users preferred long-acting products (systemically or vaginally delivered), though on-demand products offering user control were also valued. Influencing factors, especially partners, shaped end-user perceptions of product attributes and acceptability. All products were linked to at least some barriers to uptake and/or use, highlighting the need to provide end-users with a range of options and assist them in identifying one that best suits their circumstances and needs. Biomedical HIV prevention development should advance products that address gaps in available options while optimizing favorable product attributes to achieve high acceptability that ultimately supports adoption and use. [ABSTRACT FROM AUTHOR]

Progress has been made to scale oral pre-exposure prophylaxis (PrEP) as part of combination HIV prevention, with the WHO recommending differentiated, simplified and demedicalized approaches. This study explored user preferences for components of a PrEP service delivery package, through a discrete choice experiment (DCE) among 307 people accessing primary healthcare services in South Africa between November 2022 and February 2023. Attributes included were: Source of information about HIV prevention and PrEP; Site for PrEP initiation and follow-up; Frequency of follow-up; PrEP pick-up point; HIV testing whilst using PrEP; Contact between appointments. A D-efficient DCE design was created with 16 choice sets in 2 blocks. DCE data were analysed using generalised multinomial logistic models. Compared to printed materials, participants preferred getting information about PrEP online (aOR = 7.73, 95% CI = 5.13–11.66) and through WhatsApp (aOR = 2.23, 95% CI = 0.98–5.55). PrEP initiation at a pharmacy or mobile clinic was valued equally to initiating PrEP at a clinic, but a community pop-up site was less preferred (aOR = 0.46, 95% CI = 0.33–0.64). There was a preference for 6-monthly over 3-monthly follow-up (aOR = 11.88, 95% CI = 5.44–25.94). Participants preferred collecting PrEP from a pharmacy (aOR = 5.02, 95% CI = 3.45–7.31), through home delivery (aOR = 2.18, 95% CI = 1.26–3.78) and from a vending machine (aOR = 1.43, 95% CI = 1.02–1.99) relative to where they initiated PrEP. Participants also preferred HIV self-testing over a healthcare provider test (aOR = 5.57, 95% CI = 3.72, 8.36). WhatsApp or Facebook groups (aOR = 4.12, 95% CI = 3.00–5.67), monthly phone calls (aOR = 2.84, 95% CI = 1.73–4.67) and weekly messages (aOR = 1.47, 95% CI = 1.10–1.97) were preferred contact between appointments, relative to no contact. To meet users' preferences, there is a need to expand decentralised and self-led HIV prevention services. [ABSTRACT FROM AUTHOR]

Copyright of AIDS & Behavior is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Campaigns to scale up Voluntary Medical Male Circumcision (VMMC) for the prevention of HIV transmission has been going on for years in selected Southern African countries, following recommendations from the World Health Organisations. Despite significant strides made in the initiative and its proven benefits, controversies surrounding the strategy have never ceased, and its future remains uncertain especially as some countries near their initial targets. Over the years, as the campaigns unfolded, a lot of insights have been generated in favour of continuing the VMMC campaigns, although some insights portray the impression that the strategy is not worthy of the risks and effort required, or that enough has been done, as the targets have now been achieved. This article proposes a scoping review that aims at synthesizing and consolidating that evidence into a baseline for a further systematic review aimed at developing sound recommendations for the future of the VMMC strategy for HIV prevention. The scoping review will target all scientific literature published on the Web of Science, Cochrane Library, Scopus, Science Direct, PubMed as well as grey literature from Google Scholar and WHO Institutional Repository for Information Sharing (IRIS) from the inception of the campaigns. The review shall be guided by Arksey and O'Malley's (2005) framework for scoping reviews, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist shall be followed. Discussion of the findings is envisioned to yield evidence that can be further analysed to give insights about risk/cost-benefits ratios of the strategy at this point in time as well as best clinical practices for the VMMC procedure, to inform the future of the strategy. This protocol is registered with the Open Science Framework, registration ID https://doi.org/10.17605/OSF.IO/SFZC9. [ABSTRACT FROM AUTHOR]

Background: Individuals who have recently acquired HIV represent a unique population because the time frame since HIV acquisition is relatively short and identification of missed HIV prevention opportunities is, therefore, closer to real time and less subject to recall bias. Identifying prevention measures used and missed opportunities for using them, can help stop further HIV transmission. Objectives: This systematic review aims to synthesise current global evidence on uptake of HIV prevention methods among people with recently acquired HIV from 2007, the year that the concept of ART as a prevention method was first introduced. Methods and analysis: MEDLINE/PubMed, EMBASE, PsycINFO, Cochrane and Web of Science databases, will be searched for articles published January 2007—December 2023. Eligible studies will be those that reported on HIV prevention methods among people with recently acquired HIV. Quality assessment of the studies selected will be undertaken, and reporting of the systematic review will be informed by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: The systematic review is expected to provide comprehensive insights into the uptake, use and adherence to HIV prevention methods among individuals with recently acquired HIV. Analysis anticipates identifying gaps in prevention coverage, missed opportunities for intervention, and variations in access to and use of prevention strategies. Sociodemographic, personal, and behavioural factors influencing prevention uptake and adherence will also be synthesised. Conclusions: The findings will be of key relevance to researchers, healthcare providers including third sector organisations/ community groups and policymakers, as they will offer insight into better understanding of missed or failed HIV prevention efforts and will help ensure future efforts meet the needs of those in need of them. [ABSTRACT FROM AUTHOR]

Background: HIV prevention trials usually require that women of childbearing potential use an effective method of contraception. This is because the effect of most investigational products on unborn babies is unknown. We assessed contraceptive use, prevalence and incidence of pregnancy and associated factors among women in a HIV vaccine preparedness study in Masaka, Uganda. Methods: HIV sero-negative women (18–45 years) at high risk of HIV infection identified through HIV counselling and testing (HCT) were recruited between July 2018 and October 2022. Study procedures included collection of baseline socio-demographics and contraceptive use data, quarterly HCT, counselling on and provision of contraceptive methods onsite/through referral, and 6-monthly urine pregnancy tests. Multivariable Logistic and Poisson regression analyses were conducted to determine factors associated with contraceptive use, prevalence, and incidence of pregnancy. Results: 652 (73%) of 891 women reported contraceptive use at baseline. Contraceptive use was higher in women who were in a relationship/married/cohabiting [adjusted odds ratio (aOR) = 1.60; 95% confidence interval (CI) 1.07–2.40] or divorced/separated/widowed [aOR = 1.86; 95% CI 1.24–2.79] versus those that were single, and among women reporting transactional sex [aOR = 2.10; 95% CI 1.16–3.80] versus those who did not. Baseline pregnancy prevalence was 4% (95% CI 3–6%) and lower in women who reported using long-acting contraceptive methods (aOR = 0.17; 95% CI 0.07–0.39) versus women who did not use these methods. A total of 65 pregnancies over 301.3 person-years of observation (PYO), an incidence rate of 21.6/100 (95% CI 16.9–27.5) PYO, higher among younger women (≤ 24 versus 25 + years, adjusted incidence rate ratio = 1.97; 95% CI 1.15–3.40). Conclusion: We observed a high pregnancy incidence in this cohort. Innovative strategies that promote sustained and consistent use of highly effective contraceptive methods especially for young women will be critical to the success of HIV prevention trials in this and similar populations. Plain Language Summary: HIV prevention trials require that women use contraception because the effect of most investigational products on unborn babies in not known. We assessed contraceptive use, incidence of pregnancy and factors associated with contraceptive use among women in a HIV vaccine preparedness study in Masaka, Uganda. HIV sero-negative women (18–45 years) at high risk of HIV infection identified through HIV counselling and testing (HCT) were recruited into the study between July 2018 and October 2022. Study procedures included collection of baseline socio-demographic and contraceptive use data, quarterly HCT, counselling on and provision of contraceptive methods onsite/through referral, and 6-monthly urine pregnancy tests. Regression analyses were conducted to determine factors associated with contraceptive use, prevalence, and incidence of pregnancy. Of 891 enrolled women, 73% reported contraceptive use at baseline. Contraceptive use was almost twice as high in women who were in a relationship/married/cohabiting or divorced/separated/widowed compared to those that were single. Women reporting transactional sex were twice as likely to use contraceptives than women who did not. 4% of the women were pregnant at the time of recruitment. Women using long-acting contraceptives had fewer pregnancies compared to non-users. Incidence of pregnancy was high, especially among younger women (≤ 24 years). Innovative strategies that promote sustained use of highly effective contraceptive methods especially for younger women will be critical to the success of HIV prevention trials. [ABSTRACT FROM AUTHOR]

Background: Adolescent girls and young women (AGYW) are disproportionately affected by HIV. Globally, in 2022, an estimated 4000 AGYW 15–24 were newly infected with HIV weekly, and nearly 78% of these infections occurred in sub-Saharan Africa. Oral Pre-Exposure Prophylaxis (PrEP) is a key HIV prevention option within an overall HIV combination prevention approach with an efficacy of over 90% when taken correctly. However, uptake of and adherence to PrEP remains low, particularly among AGYW. This scoping review aims to map available evidence on factors that limit PrEP use among AGYW in Eastern, Southern, and Western African countries to inform research, policy, and practice on delivery of PrEP. Our review identified factors that affect PrEP journey among AGYW along the HIV prevention cascade. Methods: Guided by Arksey and O'Malley framework and using the PRISMA extension for scoping reviews, we searched the Web of Science, Global Health, and PubMed databases. Our review focused on oral PrEP, specifically papers reporting on barriers to PrEP experienced by AGYW, and peer-reviewed English-language articles published between 2012 and 2023. Results: Of 1063 papers screened, 25 were included. Over half (60%) of the studies were qualitative; 72% were conducted in Kenya and South Africa. The barriers affecting motivation were, fear of side effects and pill burden, percieved low HIV risk, perceived stigma, PrEP use disapproval from parents and partners. PrEP access was limited by healthcare providers' stigma, isolated clinic setup, and lack of resources. Effective PrEP use was limited by a lack of parental or partner support, stigma, and lifestyle changes. Conclusions: Adolescent girls and young women face multiple and often intersecting barriers to effective PrEP use with stigma being a factor cross-cutting all steps of the prevention cascade. Similarly, lack of social support, reflected through disapproval and judgmental attitudes and low HIV risk perception, also affected two steps of the prevention cascade. Our review identified gaps in available evidence, with most studies conducted in only two countries and few quantitative studies available. Improving PrEP uptake and adherence requires interventions that address barriers across the cascade, with a particular focus on stigma and social support. [ABSTRACT FROM AUTHOR]

Background: In 2023, an estimated 1.3 million people newly acquired HIV. In the same year, 3.5 million individuals received pre-exposure prophylaxis (PrEP), falling short of the UNAIDS target of 21.2 million by 2025. With over 90% of global PrEP programming supported by PEPFAR, a better understanding of disparities in PrEP provision is needed to inform PEPFAR's approach to reach and deliver prevention services and achieve UNAIDS 95-95-95 goals in all populations by 2025. The objective of this paper is to assess unmet PrEP need in PEPFAR-supported countries. Methods: We analyzed FY2023 Monitoring, Evaluation, and Reporting (MER) results from 48 PEPFAR-supported countries to calculate PrEP-to-need ratios (PnR) by geography and population. PnR offers an ecological measure to identify disparities and missed opportunities for PrEP programming. PnR was calculated as the ratio of PrEP users to the number of positive HIV tests. PrEP users are defined through new initiations (PrEP_NEW) and re-initiations or continuation (PrEP_CT). HTS_TST_POS measures the number of positive HIV tests and was used as a proxy for new diagnoses. PnR was also calculated using Naomi-estimated 2023 HIV incidence, where available. A higher PnR indicates more PrEP users relative to PrEP need in a population. Results: In FY23, 1,760,888 people initiated PrEP, and 1,736,144 people tested positive for HIV. PnR ranged from 0.12 (India) to 6.46 (Brazil), and 19 (40%) countries had fewer PrEP users than positive HIV tests (PnR <1.0). By population, people 15–24 years old, people who inject drugs, and transgender populations had the highest median PnR. When examining estimated HIV incidence, Mozambique and South Africa reported lower than average PnR and higher than average HIV incidence. Conclusion: PrEP use relative to population need varied greatly by country and subpopulation across PEPFAR programs, suggesting a need for greater advocacy, inclusivity, accessibility, and integrated prevention programming. PnR may be a useful indicator of population PrEP coverage and unmet need, and can inform effective, data-driven, and person-centered PEPFAR prevention programming and policies. Tailoring PrEP scale-up strategies by age, sex, key population, and geography is crucial to achieving UNAIDS targets and ending the AIDS epidemic as a public health threat for all by 2030. [ABSTRACT FROM AUTHOR]

Background: Long-acting injectable antiretrovirals (LAI-ARVs) for HIV prevention and treatment have been demonstrated in clinical trials to be non-inferior to daily oral medications, providing an additional option to help users overcome the challenges of daily adherence. Approval and implementation of these regimens in low- and middle-income settings have been limited. Method: This study describes the anticipated barriers and facilitators to implementing LAI-ARVs in Vietnam to inform future roll-out. From July to August 2022, we conducted 27 in-depth interviews with healthcare workers and public health stakeholders involved in HIV programs at national, provincial, and clinic levels across four provinces in Vietnam. The interviews followed a semi-structured questionnaire and were audio recorded. Data were analyzed using a rapid thematic analysis approach to identify facilitators and barriers to the adoption of LAI-ARVs. Results: In total, 27 participants from 4 provinces were interviewed including 14 (52%) men and 13 (48%) women. Participants median age was 48 years and they had 11.5 years of experience with HIV services and programs. Perceived user-level facilitators included the greater convenience of injectables in comparison to oral regimens, while barriers included the increased frequency of visits, fear of pain and side effects, and cost. Clinic-level facilitators included existing technical capacity to administer injections and physical storage availability in district health centers, while barriers included lack of space and equipment for administering injections for HIV-related services, concerns about cold chain maintenance for LAI-ART, and workload for healthcare workers. Health system-level facilitators included existing mechanisms for medication distribution, while barriers included regulatory approval processes and concerns about supply chain continuity. Conclusion: Overall, participants were optimistic about the potential impact of LAI-ARVs but highlighted important considerations at multiple levels needed to ensure successful implementation in Vietnam. Clinical trial number: Not applicable. [ABSTRACT FROM AUTHOR]

Since the introduction of oral pre-exposure prophylaxis (PrEP) in 2016, countries have successfully scaled-up PrEP to populations at risk of HIV acquisition, including key populations, serodiscordant couples and pregnant women. Between 2016 and 2023, there were over 5.6 million oral PrEP initiations globally. Of these, over 1.2 million occurred in South Africa, with nearly 700,000 implemented through USAID/South Africa's PEPFAR program. This case study uses WHO's Building Blocks for Health Systems Strengthening to describe USAID's oral PrEP program in South Africa, reporting experiences and lessons learned in 14 districts across 7 provinces. Key lessons include: (i) Substantial donor financial investment was critical for expanding oral PrEP in South Africa, but sustained leadership and investment from government stakeholders, such as the Department of Health and the National Treasury, have been essential for sustainability. Despite fluctuations in USAID funding, annual PrEP initiations have continued to increase in USAID-supported districts largely due to local leadership. (ii) Health information and supply chain systems required agility to monitor oral PrEP introduction and scale-up. When systems lacked agility, temporary solutions like the development of interim reporting tools were necessary. (iii) Integrating community-based and facility-based service delivery supported client-centered care. Nurses and lay health workers contributed to over 80% of the full-time equivalents supporting PrEP under USAID's human resources for health portfolio. (iv) Integrating sexual and reproductive health services with oral PrEP service delivery provided clients with comprehensive, client-centered care. (v) Other client-centered care included differentiated service delivery options, such as mobile and gazebo modalities, and expanded PrEP choice through implementation science activities for new PrEP products. (vi) USAID-supported PrEP initiations have been highest among females of reproductive age in the general population and men who have sex with men among key populations, priority populations in South Africa. As done in this case study, sharing best practices and lessons learned from USAID/South Africa's oral PrEP program can strengthen the implementation evidence base and inform more efficient PrEP service delivery, particularly as new PrEP products become available. [ABSTRACT FROM AUTHOR]

Background: Contingency management (CM), an incentive-based intervention to encourage target behaviors, effectively promotes medication adherence. However, efforts to extend CM to HIV pre-exposure prophylaxis (PrEP) have been lacking. As part of a randomized clinical trial to promote HIV Prevention among people who inject drugs (PWID), we examined the readiness of staff in community-based organizations serving PWID to implement CM for PrEP uptake and adherence in this population. Methods: From April to August 2022, we conducted a survey of staff from four community-based organizations providing HIV testing, harm reduction, and outreach services in the northeastern United States. We assessed knowledge and attitudes regarding PrEP for PWID on five-point Likert scales (e.g., Poor to Excellent, Not at all to Extremely). Using a modified version of the Contingency Management Beliefs Questionnaire, we assessed the degree to which attitudes about CM for HIV prevention influenced interest in its adoption on a scale from "1-No influence at all" to "5-Very strong influence". We explored endorsement patterns, along with average values of individual items and subscale scores. Results: Among 271 staff invitations, 123 (45.4%) responded. The majority (88.6%) of respondents reported prior PrEP awareness, with a mean self-rated knowledge of 2.98 out of 5 (SD = 1.1). Attitudes towards PrEP, including its relevance to and importance for clients (both means = 4.3), efficacy (mean = 4.5), and safety (mean = 4.2), were positive. Items related to practicality and confidence in providing PrEP-related care had relatively lower ratings. Respondents endorsed influential generalized (mean = 2.1) and training-related (mean = 2.5) CM implementation barriers less frequently than positive attitudes towards CM (mean = 3.6). Staff favored adding CM to existing services (mean = 3.8), and highly endorsed it as "useful for targeting HIV prevention with PrEP" (mean = 3.7). Conclusions: Respondents generally supported the use of CM to promote HIV prevention among PWID and favored adding it to their existing services. Though respondents understood the value of both PrEP and CM to support HIV prevention activities, findings corroborate research citing relative lack of knowledge and confidence regarding PrEP management among clients, potentially detracting from implementation readiness. Trial Registration Number: NCT04738825. [ABSTRACT FROM AUTHOR]

Introduction: Despite the need for reliable questionnaires to monitor self-management in chronic disease patients, such tools are lacking in developing countries. This study aims to pilot and assess the construct validity of the HIV-SM LMIC questionnaire. Method: The validation of the HIV-SM LMIC questionnaire involved two cross-sectional studies in Ethiopia. The first round, for exploratory factor analysis (EFA), included 261 patients, while the second round, for confirmatory factor analysis (CFA), included 300 patients. Data was collected using the Kobo Collect electronic data entry template. Result: The sample adequacy test showed a good value of 0.82. In the first round, 6 of the 32 items were not loaded, forming three factors in the EFA. Four of these items were dropped, but two (PSMB2 and PSMB12) were retained for their content. In the second round, CFA on the remaining 28 items led to dropping 8 more items due to conceptual overlap, resulting in a 20-item questionnaire. The final items were structured into three dimensions: awareness and well-being (4 items), self-regulation (6 items), and self-management practices (10 items). Conclusion: The study refined the original 32-item HIV-SM LMIC questionnaire to a validated 20-item, three-dimensional tool with an acceptable goodness of fit. The authors recommend further cross-cultural and predictive validation and adaptation for newly diagnosed HIV patients, those with poor treatment outcomes. [ABSTRACT FROM AUTHOR]

OBJECTIVE: In Lebanon, HIV prevalence among key populations such as men who have sex with men is high at 12%, warranting a need for targeted healthcare efforts. Pre-exposure prophylaxis (PrEP) is an effective prevention measure, yet global challenges persist, including limited awareness of PrEP among healthcare professionals. This study investigates PrEP awareness within the Lebanese medical community. METHODS: A survey targeted 201 participants from the Saint Joseph University of Beirut, Faculty of Medicine, comprising students, residents, and physicians. Analyses, including chi-square tests, mid- P exact test, and point-biserial correlation, assessed PrEP knowledge and perceptions. RESULTS: Significant disparities in PrEP awareness were noted among medical students, residents, and physicians, revealing misconceptions about its purpose, administration, and effectiveness. Positive correlations between age and awareness among medical students suggest evolving awareness during medical education. Residents exhibited higher awareness compared to physicians, emphasizing the impact of recent training. No significant correlation based on specialty was found among physicians, indicating the need for uniform PrEP education across all medical fields. CONCLUSION: Addressing PrEP awareness gaps among medical professionals is crucial for effective HIV prevention in Lebanon, necessitating tailored educational strategies integrated into medical curricula and ongoing professional development. [ABSTRACT FROM AUTHOR]

Background: HIV disproportionately impacts people who experience incarceration. Incarceration represents an opportunity to engage in HIV prevention care for individuals who often experience a number of barriers accessing health services in the community. The development of evidence-based practices promoting pre-exposure prophylaxis for HIV prevention (PrEP) is crucial for ending the HIV epidemic within this highly marginalized population. However, PrEP research within carceral facilities has been limited and is hampered in part by the lack of ethical guidance on conducting HIV prevention research in this unique setting where incarcerated individuals are categorized as a vulnerable population requiring specific protections. This lack of knowledge is particularly striking when considering the lack of input from incarcerated individuals themselves on the responsible conduct of research, which is critical to understanding ways to ensure participant autonomy while avoiding coercive practices in research activities. Methods: In order to gain a better understanding of ethical approaches to the conduct of HIV prevention research among incarcerated individuals, we conducted qualitative interviews with 21 incarcerated men who reported injecting drugs and met clinical criteria for PrEP use. The interview topics included HIV knowledge, PrEP knowledge, stigma, and perceptions related to ethical research practices. Results: Themes identified included how forced abstinence during incarceration can negatively affect research participation, the importance of participant comfort as it relates to ensuring autonomy in decision making, a desire for person centred approaches in research activities, study staff characteristics impacting participant experience, and perceptions of carceral staff as members of research teams. Conclusions: The results of this study indicate that conducting research focused on improving PrEP use in a carceral environment has support among those experiencing incarceration. However, researchers should place the participant experience at the center of research protocol development. [ABSTRACT FROM AUTHOR]

Background: We assessed the willingness of female students at a Ugandan public university to use long-acting Cabotegravir (CAB-LA) for HIV prevention, given their high prevalence of HIV risk behaviours. Methods: Using an online questionnaire, this cross-sectional study surveyed 346 female undergraduate students aged 18–25. Factors influencing their willingness were analysed with modified Poisson regression and robust standard errors. Results: More than half, 56.7% (95% CI: 51.4 to 61.8), were willing to use CAB-LA. Willingness was significantly associated with being sexually active in the past 3 months, using alcohol in the past 6 months, or being in the 4th year of study compared to the 1st year. Conclusion: Educational initiatives on innovative HIV prevention strategies, such as CAB-LA, should be introduced early in university students' studies to increase awareness and acceptance. [ABSTRACT FROM AUTHOR]

Background: Individuals can learn their HIV status through voluntary HIV counseling and testing (VCT), which also serves as a crucial access point for prevention, treatment, care, and support programs. VCT has grown in significance as a component of HIV prevention and care in Ethiopia because of its viability and convenience for the wider community, as well as its ability to provide access to care, treatment, and support for those in need. However, studies on this topic are limited, particularly because the fidelity of Ethiopia's VCT program has not been evaluated or measured. Therefore, this study aimed to assess the current implementation status of VCT services and client satisfaction in public health facilities in Gondar City. Methods: This cross-sectional study was conducted out from June to July 2022. This study involved 130 counselors and 423 VCT users. Information on physical facilities, client satisfaction, and counselor impressions of the services was gathered using a standardized and pre-tested questionnaire, observation checklists, and resource inventory checklists developed from Ethiopian national VCT guidelines, the World Health Organization, United Nations AIDS, and previous literature. In the bivariate and multiple logistic regression models, variables with p values ≤ 0.2 and < 0.05 were chosen as candidate variables and associated variables, respectively. Results: The overall implementation and facility readiness for VCT services was found to be 67%. The overall client satisfaction rate was 71% (95% CI: 69.7%, 72.7%). Age of participants from 25 to 30 years (AOR = 1.11, 95% CI, 1.02–1.21), 31–35 years (AOR = 2.03, 95% CI, 1.88–2.18), higher educational status (AOR = 1.18, 95% CI, 1.03–2.01), and comprehensive knowledge of HIV/AIDS (AOR = 2.42, 95% CI, 1.53,3.32) were positively associated with client satisfaction, whereas fear of confidentiality (AOR = 0.42, 95% CI, 0.20, 0.63) and longer waiting time (AOR = 0.09, 95% CI, 0.04, 0.15) were negatively associated with the outcome variable. Conclusion: The implementation fidelity was evaluated to be low; however, client satisfaction was somewhat good. Based on the descriptive and analytical findings, providers' adherence to standards, strong communication with leaders, and the preservation of client confidentiality and privacy must be ensured by having VCT centers meet the necessary standards as outlined in the HTC guidelines to increase client uptake and satisfaction. To enhance the quality of the program, it is important to address clients' educational levels, improve participants' understanding of VCT, promote youth participation, and provide training to service providers. [ABSTRACT FROM AUTHOR]

Background: Men who have sex with men (MSM) globally face a high risk of HIV infection. Previous studies indicate that customized short message service (SMS) interventions could reduce high-risk behaviors that associated with HIV transmission. This study aims to evaluate the health and economic impacts of such interventions among MSM in China. Methods: A decision tree-Markov model was developed for a simulated cohort of 100,000 MSM of 20 years old. We assessed three intervention strategies: (1) routine strategy with standard health information; (2) SMS strategy with customized messages based on individual high-risk behaviors, with 50.1% efficacy and 50% coverage; (3) LEN-LA (lenacapavir long-acting) strategy as pre-exposure prophylaxis (PrEP), with 100% efficacy lasting for 0.5-year and 50% coverage. The study period was 45 years. Primary outcomes included the number of HIV infections and HIV-related deaths. The cost-effectiveness, cost-utility and cost-benefit analyses were conducted along with sensitivity analyses from the healthcare sector perspective. Results: The SMS strategy was more effective, averting 6,191 (22.0%) HIV infections and 2,100 (38.5%) HIV-related deaths when compared with routine strategy. The average cost-effectiveness ratios (ACERs) were US$6,361 (95% CI: 5,959-6,613) per HIV infection averted and US$18,752 (95% CI: 17,274 − 20,530) per HIV-related death averted. It had incremental cost-effectiveness ratios (ICERs) of US$1,743 (95% CI: 1,673-1,799) per QALY, with a benefit cost ratio (BCR) of 1.98 (95% CI: 1.94–2.02), compared with routine strategy. While the LEN-LA strategy may be the most effective, its high cost, coupled with the highest ICER, currently presents a considerable obstacle to its widespread adoption. The ICERs were most affected by the probability of HIV infection, intervention cost and coverage. Conclusions: SMS strategy for preventing HIV among MSM in China is cost-effective and could be a promising strategy for HIV prevention. These findings may have implications for public health policy and resource allocation in HIV prevention efforts targeting high-risk populations. [ABSTRACT FROM AUTHOR]

Background: Awareness of Human Immunodeficiency Virus (HIV) is limited in Muslim countries, even among high-risk populations. Several factors contribute to the misunderstandings and stigma surrounding HIV, including socio-cultural and religious aspects. This study explored people's experiences and perceptions of HIV awareness campaigns in the Gulf Cooperation Council (GCC) region. Methods: We conducted a qualitative study using semi-structured interviews with participants from the GCC region. The data were analysed using reflexive thematic analysis methods. Results: Twenty-seven participants took part in this study. The data revealed five main themes: The Necessity of HIV/AIDS Awareness, The Contrast Between Traditional and Modern Awareness, Exploring the Balance: Moral vs. Health Messages, HIV/AIDS Awareness in GCC countries, and Key Providers of HIV/AIDS Awareness. All participants emphasised the need to raise awareness about HIV in the GCC, believing that recent societal changes and increased openness justify the need for sexual health education. They stressed the importance of delivering clear and assertive health education to raise awareness while minimising the reliance on fear-based messaging. However, some participants expressed concerns about promoting condom use and HIV treatment, fearing it might encourage extramarital sex. Additionally, the lack of a religious component in the awareness messages raised concerns among some participants, as they believed adhering to religious practices was the best protection against HIV. Conclusions: Muslims in the GCC recognise the importance of spreading awareness about HIV. However, they stress the need to balance religious sensitivity with the delivery of open and transparent health messages. Engaging the target community, including high-risk individuals, in planning health campaigns is crucial for improving the acceptance, reach, inclusivity, and understanding of health awareness programs. [ABSTRACT FROM AUTHOR]