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.

Despite established efficacy for oral pre-exposure prophylaxis (PrEP) in reducing HIV incidence, multi-level barriers within the health system, clinics, and the processes that shape practice have hindered service delivery and subsequent population-level effects. We applied the Consolidated Framework for Implementation Research (CFIR) to assess the context of PrEP delivery for adolescent girls and young women (AGYW) in rural South Africa and identify the factors supporting and impeding PrEP implementation to develop strategies to improve PrEP delivery. Between 2021 and 2022, we conducted in-depth interviews with five young women with PrEP use experience and 11 healthcare providers as well as four key informant stakeholder interviews. Tailored interviews organized around the CFIR domains provided multiple perspectives on the inter-connected processes, gaps, and opportunities between health systems, clinics, communities, and PrEP services. Shifts in PrEP policies, funding pressures, and inconsistent communications from the National Department of Health spurred fragmented planning, engagement, execution, and monitoring of PrEP delivery processes within clinics already struggling to address multiple population health needs. Resulting challenges included: conflicting priorities within clinics and across NGO partners, unclear goals and targets, staffing and space constraints, and insufficient community engagement. Individual clinics' implementation climate and readiness to deliver PrEP varied in terms of operational plans and delivery models. Interviewees reported complexity of initiation procedures and support for PrEP maintenance, with opportunities to improve systems communications and processes to facilitate integrated services and more user-friendly experiences. Applying CFIR identified opportunities to strengthen PrEP delivery across levels within this complex service delivery setting.

BackgroundThere are few data on tenofovir-diphosphate (TFV-DP) concentrations in pregnant and postpartum women on Tenofovir Disoproxil Fumarate-Emtricitabine (TDF-FTC) or Tenofovir Alafenamide-Emtricitabine (TAF-FTC).MethodsEligible pregnant women were randomized to TDF-FTC or TAF-FTC and followed for 16 weeks (8-weeks pregnant, 8-weeks postpartum) with weekly collection of dried blood spot (DBS) and 4-weekly peripheral blood mononuclear cells (PBMC). PrEP dosing was observed daily via asynchronous videos sent via cell phone. We report geometric means (GM) and their ratios (GMR) with 95% confidence intervals (CIs) for TFV-DP in PBMC and DBS from pregnancy and postpartum.ResultsWe enrolled N = 39 participants (n = 19 TDF-FTC, n = 20 TAF-FTC): median age was 28 years (IQR:25-34); median gestational age was 24-weeks (IQR:21-28). For TDF-FTC, TFV-DP DBS concentrations at 8-weeks did not differ significantly between pregnancy (GM: 675; 95%CI:537-849) and postpartum (GM: 583; 95%CI:471-722; GMR-TDF = 1.16; 95%CI:0.74-1.80). For TAF-FTC, TFV-DP DBS concentrations at 8-weeks were 44% higher in postpartum (GM: 1199; 95%CI:929-1549) versus pregnancy (GM: 832; 95%CI:751-922; GMR-TAF = 1.44; 95% CI: 1.01-2.06). In PBMC analysis of TDF-FTC, 8-week median TFV-DP (pmol/10^6 cell) was 71 (IQR 44-112) in pregnancy and 73 (IQR 50-102) in postpartum (GMR = 1.04; 95%CI:0.44-2.44). In TAF-FTC, median PBMC at 8-weeks was 580 (IQR:341-985) in pregnancy and 666 (IQR:396-1123) in postpartum (GMR = 1.15; 95%CI:0.30-2.49).ConclusionTFV-DP concentrations were overall lower during pregnancy than postpartum for TAF-FTC. We found high concentrations of TFV-DP in PBMC in pregnancy and postpartum on TAF-FTC, suggesting PrEP efficacy is maintained. Efficacy and safety studies are warranted to evaluate TAF-FTC for PrEP in pregnant and postpartum women.

Decision-making on childbearing and safer conception use in HIV sero-different couples involves an intricate balance of individual desires and perceived HIV acquisition risk. This paper addresses an important knowledge gap regarding HIV sero-different couples considerations and the relationship and power dynamics involved when deciding to use a safer conception method. 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 study assessing the feasibility, acceptability and cost-effectiveness of a safer conception programme for HIV sero-different couples in Zimbabwe. All couples in SAFER were provided with a choice of safer conception methods and were followed for up to 12 months of pregnancy attempts and 3 months following pregnancy. While couples generally perceived their safer conception discussions to be easy and consensus-driven, the decision-making process also involved complex gender dynamics and trade-offs in relationship power, which resulted in differing interpretations of what constituted a joint or shared couple decision. Participants regarded effective couple communication as an essential component of and precursor to good safer conception conversations and requested additional training in couple communication. Couples relied on information from healthcare providers to kickstart their safer conception discussions. Safer conception programmes should address relationship power imbalances, promote effective couple communication and offer healthcare provider support to enable HIV sero-different couples to make informed choices about conception in a manner that upholds their safety and reproductive autonomy.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) for HIV-1 infection is over 99% effective in protecting against HIV acquisition when used consistently and appropriately. However, PrEP uptake and persistent use remains suboptimal, with a substantial gap in utilization among key populations who could most benefit from PrEP. In Latin America specifically, there is poor understanding of barriers to PrEP uptake and persistence among transgender (trans) women. METHODS: In April-May 2018, we conducted qualitative interviews lasting 25-45 min as part of an end-of-project evaluation of TransPrEP, a pilot RCT that examined the impact of a social network-based peer support intervention on PrEP adherence among trans women in Lima, Peru. Participants in the qualitative evaluation, all adult trans women, included individuals who either (1) screened eligible to participate in the TransPrEP pilot, but opted not to enroll (n = 8), (2) enrolled, but later withdrew (n = 6), (3) were still actively enrolled at the time of interview and/or successfully completed the study (n = 16), or (4) were study staff (n = 4). Interviews were audio recorded and transcribed verbatim. Codebook development followed an immersion/crystallization approach, and coding was completed using Dedoose. RESULTS: Evaluation participants had a mean age of 28.2 years (range 19-47). When describing experiences taking PrEP, participant narratives highlighted side effects that spanned three domains: physical side effects, such as prolonged symptoms of gastrointestinal distress or somnolence; economic challenges, including lost income due to inability to work; and social concerns, including interpersonal conflicts due to HIV-related stigma. Participants described PrEP use within a broader context of social and economic marginalization, with a focus on daily survival, and how PrEP side effects negatively contributed to these stressors. Persistence was, in some cases, supported through the interventions educational workshops. CONCLUSION: This research highlights the ways that physical, economic, and social side effects of PrEP can impact acceptability and persistence among trans women in Peru, amplifying and layering onto existing stressors including economic precarity. Understanding the unique experiences of trans women taking PrEP is crucial to informing tailored interventions to improve uptake and persistence.

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.

In the pursuit of ending the HIV epidemic, U.S. emergency departments (EDs) have emerged as a valuable setting to increase HIV testing and linkage to care. There is limited data available, however, describing the incorporation of HIV prevention initiatives in U.S. EDs. Over the last decade, HIV pre-exposure prophylaxis (PrEP) has significantly changed the HIV prevention landscape globally and very little is known about the provision of PrEP in U.S. EDs. To address this gap in the literature, we conducted a systematic review of peer-reviewed quantitative studies and conference abstracts spanning July 2012 - October 2022. Of 433 citations, 11 articles and 13 abstracts meet our inclusion criteria, representing 18 unique studies addressing PrEP screening, prescribing, and/or linkage to PrEP care.Most studies describe screening processes to identify PrEP-eligible patients (n = 17); most studies leveraged a patients STI history as initial PrEP eligibility screening criteria. Fewer studies describe PrEP prescribing (n = 2) and/or linkage to PrEP care (n = 8).Findings from this systematic review highlight the potential for U.S. EDs to increase PrEP uptake among individuals at risk for HIV infection. Despite a growing number of studies exploring processes for incorporating PrEP into the ED setting, such studies are small-scale and time limited. Models providing prescribing PrEP in the ED show higher initiation rates than post-discharge engagement models. Electronic health record (EHR)-based HIV screening is valuable, but post-ED linkage rates are low. Our findings emphasize the need to establish best practices for initiating and supporting prevention effective PrEP use in the ED setting.

BackgroundPregnant and postpartum women in Sub-Saharan Africa are at high risk of HIV acquisition. We evaluated a person-centered dynamic choice intervention for HIV prevention (DCP) among women attending antenatal and postnatal care.SettingRural Kenya and Uganda.MethodsWomen (aged 15 years or older) at risk of HIV acquisition seen at antenatal and postnatal care clinics were individually randomized to DCP vs. standard of care (SEARCH; NCT04810650). The DCP intervention included structured client choice of product (daily oral pre-exposure prophylaxis or postexposure prophylaxis), service location (clinic or out of facility), and HIV testing modality (self-test or provider-administered), with option to switch over time and person-centered care (phone access to clinician, structured barrier assessment and counseling, and provider training). The primary outcome was biomedical prevention coverage-proportion of 48-week follow-up with self-reported pre-exposure prophylaxis or postexposure prophylaxis use, compared between arms using targeted maximum likelihood estimation.ResultsBetween April and July 2021, we enrolled 400 women (203 intervention and 197 control); 38% were pregnant, 52% were aged 15-24 years, and 94% reported no pre-exposure prophylaxis or postexposure prophylaxis use for ≥6 months before baseline. Among 384/400 participants (96%) with outcome ascertained, DCP increased biomedical prevention coverage 40% (95% CI: 34% to 47%; P < 0.001); the coverage was 70% in intervention vs. 29% in control. DCP also increased coverage during months at risk of HIV (81% in intervention, 43% in control; 38% absolute increase; 95% CI: 31% to 45%; P < 0.001).ConclusionA person-centered dynamic choice intervention that provided flexibility in product, testing, and service location more than doubled biomedical HIV prevention coverage in a high-risk population already routinely offered access to biomedical prevention options.

BackgroundPrEP, a biomedical HIV prevention option, continues to be underutilized among transgender women who could benefit from sustained use, especially women of color and those who identify as Latina and/or reside in the southeastern US.ObjectiveWe explored the barriers and facilitators experienced by transgender women who live in Florida regarding accessing, using, and/or staying on PrEP.MethodsIn-depth interviews and focus groups were conducted in either Spanish or English with adult transgender women living in Florida (N = 22). The interviews were audio-recorded, transcribed, and coded in ATLAS.ti using thematic analyses.ResultsThe mean age of the participants was 42.2 years. Among the participants, 73% were Hispanic/Latina, 59% were foreign-born, and approximately one-third were living with HIV (but had past experience with PrEP). Transgender women cited the following barriers to accessing or considering PrEP: (1) costs and benefits of PrEP use; (2) under-representation in clinical trials resulting in unknown or misinformation regarding PrEP side effects; (3) chronic poverty; and (4) trauma and discrimination. Other stressors, such as behavioral healthcare needs, were identified.ConclusionsOur analysis revealed interlocking systems of oppression like transphobia, discrimination, and misgendering, which were common barriers experienced by our participants. These synergistically epidemic (i.e., syndemic) barriers contributed to their feelings of being systematically excluded in social spaces, research, public health planning and policies, laws, and social programs related to PrEP. These structural barriers are impediments to HIV preventive care but also act as a source of stress that contributes to mental health problems, financial vulnerability, substance abuse, and other deleterious health outcomes.

Polygamy is the practice of marriage to multiple partners. Approximately 6-11% of households in Uganda and 4-11% of households in Kenya are polygamous. The complex families produced by polygamous marriage customs give rise to additional considerations for healthcare providers and public health messaging around HIV care. Using 27 in-depth, semi-structured qualitative interviews with participants in two studies in rural Kenya and Uganda, we analysed challenges and opportunities that polygamous families presented in the diagnosis, treatment and prevention of HIV, and provider roles in improving HIV outcomes in these families. Overall, prevention methods seemed more justifiable to families where co-wives live far apart than when all members live in the same household. In treatment, diagnosis of one member did not always lead to disclosure to other members, creating an adverse home environment; but sometimes diagnosis of one wife led not only to diagnosis of the other, but also to greater household support.

Transgender women (TW) face inequities in HIV and unique barriers to PrEP, an effective biomedical intervention to prevent HIV acquisition. To improve PrEP retention among TW, we examined factors related to retention using a two-phase, sequential explanatory mixed methods approach. In Phase I, we used data from a trial of 170 TW who were provided oral PrEP to examine predictors of 24-week retention. In Phase II, we conducted 15 in-depth interviews with PrEP-experienced TW and used thematic analysis to explain Phase I findings. In Phase I, more participants who were not retained at 24 weeks reported sex work engagement (18% versus 7%) and substantial/severe drug use (18% versus 8%). In Phase II, participants reported drug use as a barrier to PrEP, often in the context of sex work, and we identified two subcategories of sex work. TW engaged in "non-survival sex work" had little difficulty staying on PrEP, while those engaged in "survival sex work" struggled to stay on PrEP. In Phase I, fewer participants not retained at 24 weeks reported gender-affirming hormone therapy (GAHT) use (56% versus 71%). In Phase II, participants prioritized medical gender affirmation services over PrEP but also described the bidirectional benefits of accessing GAHT and PrEP. TW who engaged in "survival sex work" experience barriers to PrEP retention (e.g., unstable housing, drug use) and may require additional support to stay in PrEP care.

Intimate partner violence (IPV) occurs at alarmingly high rates towards pregnant women in South Africa. Experiences of emotional, physical, and sexual IPV in pregnancy can adversely impact the health and safety of mother and fetus. Furthermore, IPV is associated with increased risk of HIV, exacerbating the public health impact of violence among pregnant women in this HIV endemic setting. In-depth understanding of cultural and contextual drivers of experiences of IPV is a critical precursor to development of interventions effectively addressing this issue among pregnant women in South Africa. The present study examines factors contributing to IPV among pregnant women to identify potential points of intervention. We conducted twenty in-depth interviews with postpartum women who used oral pre-exposure prophylaxis (PrEP) in pregnancy and reported recent experiences of IPV and/or ongoing alcohol use in a township near Cape Town, South Africa that experiences a heavy burden of both HIV and IPV. Interpretive thematic analysis was used. Several patterns of IPV during pregnancy were identified and violence was frequently described as co-occurring with male partner alcohol use. A majority of women referenced oral PrEP as their preferred method for HIV prevention, highlighting the agency and discretion it provided as beneficial attributes for women experiencing IPV. Fear of judgement from peers for remaining with an abusive partner and a lack of clear community messaging around IPV were identified as barriers to disclosure and support-seeking. Addressing the lack of social support received by women experiencing IPV during pregnancy in South Africa is essential to comprehensive IPV programming.

Introduction: Pregnant and breastfeeding women at substantial risk for HIV infection in sub-Saharan Africa can benefit from biomedical interventions such as pre-exposure prophylaxis (PrEP). We estimated the benefit that pregnant and breastfeeding women may derive from PrEP service delivery in order to guide PrEP roll-out in the target population in Zambia. Methods: Between September and December 2021, we conducted a discrete choice experiment (DCE) among a convenient sample of 389 pregnant and breastfeeding women not living with HIV in Lusaka, Zambia. Women aged 18 years or older, with a documented negative HIV result in their antenatal card responded to a structured questionnaire containing 12 choice sets on service delivery attributes of PrEP: waiting time at the facility, travel time to the facility dispensing PrEP, location for PrEP pick-up, health care provider attitude and PrEP supply at each refill. Mixed logit regression analysis was used to determine the participant's willingness to trade off one attribute of PrEP for the other at a 5% significance level. Willingness to wait (WTW) was used to determine the relative utility derived from each attribute against waiting time. Results: Waiting time at the facility, travel time to the facility, health care provider attitude and amount of PrEP supply at each refill were important attributes of PrEP service delivery (all p < 0.01). Participants preferred less waiting time at the facility (β = −0.27, p < 0.01). Women demonstrated a strong preference for a 3-months' supply of PrEP (β = 1.69, p < 0.01). They were willing to wait for 5 h at the facility, walk for more than an hour to a facility dispensing PrEP, encounter a health care provider with a negative attitude in order to receive PrEP enough for 3 months. Conclusion: Patient-centered approaches can help to inform the design and implementation of PrEP services among pregnant and breastfeeding women. In this study, we found that a reduction in clinic visits—including through multi-month dispensing of PrEP—could improve uptake of services in antenatal and postnatal settings. [ABSTRACT FROM AUTHOR]

AbstractObjectiveParticipantsMethodsResultsConclusionA mixed-methods study exploring PrEP (Pre-exposure Prophylaxis) access, services, and acceptance among Black college students at Historically Black Colleges and Universities (HBCUs) and Minority Serving Institutions MSIs in Georgia was conducted.This study included faculty, administrators, and staff and Black students aged (18 – 24) from three HBCUs and one MSI.The research utilized key informant interviews (n = 17), focus groups (n = 7) a student survey (n = 163).Key findings revealed that the main barriers to PrEP uptake are cost, lack of education, insufficient personnel, and inconsistent partnerships with community providers. More than 60% of students were sexually active, with nearly 48% engaging in unprotected sex. Approximately one-third of students were aware of PrEP in either the pill or injectable form.This study highlights the need for increased education and access to PrEP at HBCUs and MSIs. [ABSTRACT FROM AUTHOR]

The world is not on track to reach the majority of the UNAIDS 2025 targets, and people who inject drugs (PWID) continue to be left behind, hindered by counterproductive law enforcement practices, punitive laws, economic distress, and social stigma and discrimination. Poor access to HIV pre-exposure prophylaxis (PrEP) among PWID is nested within the limited access to broader harm reduction services, including needle and syringe programs, opioid overdose management, opioid agonist therapy (also known as medication-assisted treatment), and condoms. Among PWID, women who inject drugs are disproportionately affected and face additional gender-based barriers. Intersections between PWID and other key and priority population groups also exist. Although the prioritization of PWID for new PrEP products like the dapivirine vaginal ring and injectable cabotegravir has lagged in research, studies have shown that PWID find injectable and long-acting options acceptable and preferrable, including among women who inject drugs. While new PrEP products introduce new opportunities, equity in access must be assured for optimized impact toward achieving epidemic control. Programming for services must engage and empower PWID community leadership to address the structural barriers to services, implement community-led, differentiated, and integrated service modalities, and offer the choice of all harm reduction options to close the equity gaps in health outcomes. While waiting for necessary evidence and approvals, programs should work together with the PWID community to prioritize, expand, and facilitate efforts and investments toward increased access to and integration of PrEP and all recommended harm reduction services for PWID. [ABSTRACT FROM AUTHOR]

In clinical trials, once-daily oral tenofovir-based pre-exposure prophylaxis (PrEP) significantly reduced HIV-1 acquisition risk; however, this was highly dependent on medication adherence and persistence. We report clinical characteristics, PrEP usage patterns, first evidence of HIV-1, and associated risk factors among adults with commercial insurance using oral PrEP in the United States using health plan claims from the IQVIA PharMetrics® Plus database between January 1, 2015, and March 31, 2020, from individuals who newly initiated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or FTC/tenofovir alafenamide (TAF) for daily PrEP. Overall, 25,419 individuals were included (FTC/TDF, n = 24,232; FTC/TAF, n = 1187), with generally similar characteristics reported during the 6-month baseline period across cohorts. Mean follow-up length was 504 and 77 days for FTC/TDF and FTC/TAF, respectively, corresponding with the 2019 approval of FTC/TAF for PrEP. Similarly, mean PrEP use duration was 354 and 68 days for FTC/TDF and FTC/TAF, respectively. PrEP breaks (>90-day gap) were observed in 11.1% of individuals using FTC/TDF, with a mean break duration of 249 days; 20.0% of individuals using FTC/TDF and 7.3% using FTC/TAF had ≥1 sexually transmitted infection diagnosis during follow-up. From 6 to 12 months of follow-up, mean FTC/TDF proportion of days covered (PDC; 0.74 vs. 0.67) and persistence (70.2% vs. 57.4%) decreased; real-world PDC and persistence were lower than reported in globally conducted clinical trials. First evidence of HIV-1 was infrequent among individuals using FTC/TDF (0.6%), though 60.3% had PrEP on hand when HIV-1 definition was met; high-risk sexual behavior, syphilis, and gonorrhea were the most important risk factors. [ABSTRACT FROM AUTHOR]

Background: The social distancing measures associated with the COVID-19 pandemic had far reaching effects on sexual behavior worldwide. However, it remains unclear whether sexual contact with non-steady partners was a contributor to the spread of SARS-CoV-2. The aim of this study was to (i) describe risk factors for SARS-CoV-2 seropositivity after the first pandemic wave among people using HIV Pre-Exposure Prophylaxis (PrEP) in Zurich, Switzerland, including sexual contact with non-steady partners, and (ii) assess whether the SARS-CoV-2 seropositivity among PrEP users in this time period differed from that of a demographic matched population level comparison group. Methods: The study was conducted between July 2020 and October 2020 as a nested cross-sectional study within two ongoing cohort studies, SwissPrEPared (all eligible PrEP users in Switzerland ≥ 18 years old) and Corona Immunitas (a series of cross-sectional and longitudinal studies measuring the SARS-CoV-2 seroprevalence across Switzerland, beginning in April 2020). All SwissPrEPared participants were recruited from Checkpoint Zurich (the main PrEP clinic in Zurich) and were men having sex with men or transgender women. Data were collected on participants' SARS-CoV-2 antibody status, social characteristics and behavioral data after the first wave of the pandemic in Switzerland, and seroprevalence was compared with a propensity score-matched sample from the general Zurich population. Results: Of the 218 participants enrolled, 8.7% (n = 19, 95% CI: 5.5–13.5%) were seropositive for SARS-CoV-2 during the first pandemic wave, higher than that of the general male population in Zurich aged 20–65 (5.5%, 95% CI: 3.8–8.2%). Participants on average reduced their social outings, but the seronegative were more socially active before, during, and after the first lockdown period. In a logistic model, increasing mean sexual partner count was not associated with seropositivity (OR: 1.02, 95% CI: 0.95, 1.07). The estimated risk ratio for seropositivity for the participants compared to the general Zurich population after propensity score matching was 1.46 (95% CI: 0.53, 3.99). Conclusions: Our study suggests that SARS-CoV-2 seropositivity was slightly elevated among people taking PrEP in Zurich during the first wave of the pandemic, but that socializing and sexual activity were less important than other factors in contributing to risk. [ABSTRACT FROM AUTHOR]

Adherence drives efficacy in PrEP clinical trials. We compared drug concentrations and self-reported adherence in HPTN069/ACTG5305, a double-blinded, randomized trial of the safety and tolerability of candidate PrEP regimens that included maraviroc (MVC), tenofovir (TDF), and emtricitabine (FTC). Plasma drug concentrations and self-reported adherence by computer-assisted self-interview (CASI) were assessed at study weeks 24 and 48. Descriptive statistics and a generalized linear model were used to assess the association between selected demographic factors, self-report of daily medication adherence and plasma drug concentrations consistent with daily adherence. Among 718 paired observations from 370 participants, 43% (306/718) reported daily adherence by CASI, 65% (467/718) had drug concentrations consistent with daily adherence and 11% (81/718) had CASI responses that reported daily adherence despite having drug concentrations consistent with less-than-daily adherence. In adjusted analyses, participants who were assigned male at birth (aOR 1.42 [95% CI 1.02, 1.97]), older (5-year increments aOR 1.10 [95% CI 1.09, 1.11]), White (aOR 2.2 [95% CI 1.88, 2.56]), had advanced education (aOR 3.89 [95% CI 2.97, 5.09]), were employed (aOR 1.89 [95% CI 1.50, 2.40]), or partnered/married (aOR 2 [95% CI 1.72, 2.32]) were more likely to have drug concentrations consistent with daily adherence. Participants who were not employed (aOR 2.7 [95% CI 1.31, 5.55]) or who were single/not partnered (aOR 2.33 [CI 95% 1.25, 4.34]) were more likely to have drug concentrations that did not reflect daily adherence despite self-reported PrEP adherence. These findings support the need for ongoing adherence counseling in clinical trials of new PrEP regimens. [ABSTRACT FROM AUTHOR]

During the 2022 mpox outbreak, our study conducted 30 interviews with a recruited sample of Chicago gay men (age 18+) during June-September to investigate their experiences of mpox, HIV/AIDS, and COVID-19. Participants were interviewed with a semi-structured guide about gay sexual identity and social experiences; HIV/AIDS, ART, and PrEP; and COVID-19 behaviors and vaccination. All 30 interview respondents had been fully vaccinated for COVID-19 and expressed minimal COVID-19 vaccine hesitancy. All the men living with HIV in our study were on ART with HIV well controlled. A majority of HIV- participants (70%) were on PrEP, with participants universally aware of PrEP benefits. Additionally, most participants had already received at least one shot of the Jynneos mpox vaccine, with many interviewees enduring long lines, sometimes at multiple locations, before vaccination in primarily gay social spaces. These Chicago gay men demonstrated widespread enthusiasm for mpox vaccination as a disease prevention strategy and most of them had already been vaccinated despite significant barriers. The enthusiasm of the participants in our study emerged within a medical landscape shaped by both COVID-19 vaccination and HIV/AIDS-related health interventions including ART and PrEP, which may have helped instill increased medical trust among this population. Our study suggests that out urban gay men may comprise a distinctive minority population with increased medical trust due to specific social, sexual, and historical experiences. [ABSTRACT FROM AUTHOR]

There is a dearth of HIV prevention behavioral interventions for transgender Latinas, despite this population's HIV risk. ChiCAS (Chicas Creando Acceso a la Salud) is an intervention to increase PrEP, condom, and gender-affirming hormone therapy (GAHT) use among transgender Latinas. To inform future work, semistructured interviews were conducted postintervention with 28 ChiCAS participants. Thematic analysis with inductive coding was used. Six themes emerged: (1) health-related priorities include sexual health and avoiding discrimination; (2) safe and collaborative community is of high importance; (3) interactive education with time for sharing stories and discussion was valued; (4) PrEP uptake was facilitated through awareness and health care navigation; (5) accessing GAHT depends on cost, clinic location, and individual goals; (6) ChiCAS could be improved with more PrEP/GAHT details and social connection. Interventions with goals similar to those of ChiCAS should prioritize building community, PrEP and GAHT education tailored to participants' needs, and emphasize health care options available locally. [ABSTRACT FROM AUTHOR]

A growing proportion of the global population engages in alternative sexual behaviors and relationships, which are commonly grouped and known as kink or BDSM (bondage-discipline, dominance-submission, sadism-masochism). Mainstream stigma and provider pathologizing of these behaviors and relationships may make kink-involved populations reticent to seek health care treatment. Moreover, some kink activities appear to expose kink-involved people to higher risks for HIV infection. To date, no studies have explored HIV risk prevention interventions for kink-involved people. The proposed study seeks to address the absence by describing a study designed to address HIV risk prevention with PrEP for this understudied and neglected population by testing an educational-entertainment intervention designed to focus on kink specifically. Using a repeated-measures randomized experimental methodology, this study proposes to include data collection and exposure to intervention materials at 3-month intervals over 12 months. [ABSTRACT FROM AUTHOR]

Despite its efficacy, pre-exposure prophylaxis (PrEP) for HIV has a low uptake, with many disparities remaining. This study aimed to assess the impact of Medicaid expansion and social determinants of health (SDOH) on PrEP prevalence and PrEP-to-need ratio (PnR) using county-level data from 2012 to 2022. Differences-in-differences regressions indicated that Medicaid expansion is associated with increased PnR but not PrEP prevalence. Linear regressions were conducted to evaluate the impact of county-level SDOH on PrEP outcomes. Rurality was associated with lower PnR and PrEP prevalence. Racial disparities were present, with areas with greater concentrations of non-Hispanic Black populations having lower PrEP prevalence and PnR. Greater concentrations of Hispanic populations were associated with lower PnR. Income inequality, socioeconomic status vulnerability, and primary care physician concentration were all associated with higher PnR. Medicaid expansion supports increasing PrEP use in the areas of greatest need. Efforts should be made to improve PrEP access, particularly in areas with high SDOH vulnerabilities. [ABSTRACT FROM AUTHOR]

This study explored the feasibility and acceptability of Entre Herman@s, a novel sibling-based intervention designed to engage siblings to increase PrEP utilization among Latino men who have sex with men (LMSM). Siblings were trained in rudimentary motivational interviewing skills to uncover, evoke, and strengthen their brother's motivation to use PrEP, using the constructs of the Information-Motivation-Behavioral Skills (IMB) model for health behavior change. This pilot demonstrated high feasibility, meeting recruitment, retention, and intervention completion targets. Of the 23 LMSM enrolled, 16 (70%) commenced PrEP, with 12 (75%) continuing at the 3-month follow-up. Initially, 15 participants (65%) were open to PrEP, with 9 (39%) ready to start within the next month. Those who began PrEP use reported a significantly higher degree of closeness to their siblings (p =.019) than those who did not. All LMSMs affirmed that their decision to use PrEP was influenced to some degree by their sibling. [ABSTRACT FROM AUTHOR]

Background: HIV Pre‐Exposure Prophylaxis (PrEP) has been available in Wales since 2017. The coronavirus disease (COVID‐19) pandemic impacted UK sexual health services, leading to a reduction in service provision. There is a lack of research on the experiences of PrEP users during this time. Objective: We aimed to explore the experiences of PrEP users in Wales following the introduction of COVID‐19 pandemic measures. Methods: We conducted a secondary data analysis of two prior interview studies (DO‐PrEP and UPrEP). Data collection was undertaken between May 2020 and February 2021 using remote interviewing. Semi‐structured interviews were conducted. Participants were ≥18 years of age, residents of Wales, current or previous PrEP users, and men who have sex with men (MSM). Reflexive thematic analysis was conducted. Results: A total of 32 interviews were included in the analysis. Themes include the following: (1) PrEP use during COVID‐19, (2) sexual behaviour and relationship changes following COVID‐19 restrictions, (3) NHS service provision during the COVID‐19 pandemic, and (4) wider contextual effects of the pandemic. Participants reported a change in PrEP use (pausing or switching to event‐based PrEP). Participants reported reduced access to clinics and appointments. Support for changing to event‐based PrEP was varied. Social isolation resulted in varied responses to lockdown rules, especially in later lockdowns. Conclusion: This study provides patient perspectives on the challenges the COVID‐19 pandemic posed to PrEP use and access. It offers insights into the broader support needs around PrEP use when an individual's circumstances change. Flexible models of PrEP provision, which can be adapted to the patient's needs, will be essential as PrEP delivery extends into the wider community. Patient and Public Contribution: Both the DO‐PrEP and UPrEP studies received input from various stakeholders in the design of the topic guides for the study; these included public lay members, PrEP users, PrEP providers, and individuals involved with HIV advocacy and policy. [ABSTRACT FROM AUTHOR]

Background: Peer-delivered HIV self-testing (HIVST) and sexually transmitted infection self-sampling (STISS) may promote adherence to oral pre-exposure prophylaxis (PrEP), but no studies have analyzed this approach among transgender women (TGW) in sub-Saharan Africa. Setting: The Peer study was a cluster randomized trial in Uganda (October 2020–July 2022; NCT04328025). Methods: Ten TGW peer groups, each with 1 TGW peer and 8 TGW, were randomized 1:1 to receive quarterly in-clinic HIV testing with PrEP refills as standard-of-care (SOC) or SOC plus monthly peer delivery of oral-fluid HIVST, STISS, and PrEP refills (intervention). Participants were followed for 12 months. The primary outcome was PrEP adherence. Results: We screened 85 TGW and enrolled 82 (41 per arm). The median age was 22 years (interquartile range [IQR] 20–24). Twelvemonth retention was 88% (72/82). At the 3, 6, 9, and 12-month clinic visits, 10%, 5%, 5%, and 0% of TGW in the intervention arm had TFV-DP levels $700 fmol/punch, versus 7%, 15%, 7%, and 2% in the SOC arm, respectively (P = 0.18). At all visits, any detectable TFV-DP levels were significantly higher in SOC than the peer delivery group (P, 0.04). PrEP adherence was associated with sex work (incidence rate ratio 6.93; 95% CI: 2.33 to 20.60) and .10 years of schooling (incidence rate ratio 2.35; 95% CI: 1.14 to 4.84). There was a strong correlation between tenofovir detection in dried blood spots and urine (P, 0.001). No HIV seroconversions occurred. Conclusions: Peer-delivered HIVST and STISS did not increase low levels of oral PrEP adherence among TGW in Uganda. Longacting PrEP formulations should be considered for this population. [ABSTRACT FROM AUTHOR]

Introduction: Barriers to pre‐exposure prophylaxis (PrEP) access have limited its reach to priority populations. Community‐based mobile clinics have potential to broaden PrEP engagement. We evaluated reach and persistence for fixed and mobile clinic cohorts in Miami‐Dade County, Florida. Methods: This observational cohort study analysed data from 1896 clients engaged through our fixed or mobile clinic from August 2018 to March 2023. Services were offered at no cost to clients. The same staff and package of barrier‐lowering strategies was deployed across fixed and mobile clinic sites. Chi‐square and Fisher's exact test or the Kruskal–Wallis test were used to test for differences in characteristics across sites as well as across services sought. Kaplan–Meier curves were generated to evaluate persistence on PrEP and in care, defined as completion of at least one clinic visit (including PrEP prescribing, for PrEP persistence, or for any reason, for persistence in care) within 24 weeks of the prior visit. Cox proportional hazards models were used to evaluate risk factors for discontinuation of PrEP or clinic care by 48 weeks by gender, race, ethnicity, insurance status and site. Results: The fixed and mobile clinics reached 781 and 1109 clients, respectively, during the study period. The median client age was 35 years; the majority (70.4%) of clients were cisgender men, identified as Hispanic/Latino (62.5%) and were men who have sex with men (54.5%). The mobile clinic extended reach to a higher proportion of cisgender women (32.1% mobile vs. 12.9% for fixed clinic), Black clients (34.5% vs. 13.1%) and older clients (median 37 vs. 33 years) compared with the fixed setting. Uninsured individuals, men and those who initiated services in the mobile clinic were more likely to continue PrEP to 48 weeks (HR: 1.20, p = 0.01; HR: 2.02, p<0.01; HR: 1.68, p<0.01, respectively). Persistence did not differ by race or ethnicity. Conclusions: A mobile clinic strategy for PrEP engagement can increase reach to key populations underrepresented in HIV prevention care including cisgender women and Black clients. Persistence in PrEP was increased for the mobile clinic cohort, suggesting an additional benefit to this modality beyond other barrier‐lowering strategies employed in our fixed and mobile clinics. [ABSTRACT FROM AUTHOR]

Introduction: Oral pre‐exposure prophylaxis (PrEP) is highly effective, but coverage remains low in high HIV prevalence settings. Initiating and continuing PrEP remotely via online pharmacies is a promising strategy to expand PrEP uptake, but little is known about potential users' preferences. Methods: We conducted a discrete choice experiment (DCE) to assess preferences for online pharmacy PrEP services. We partnered with MYDAWA, an online pharmacy in Nairobi, Kenya. Eligibility criteria were: ≥18 years, not known HIV positive, interested in PrEP. The DCE contained four attributes: PrEP eligibility assessment (online self‐assessed, guided), HIV test type (provider administered, oral HIV self‐test [HIVST], blood‐based HIVST), clinical consultation (remote, in‐person) and user support options (text messages, phone/video call, email). Additionally, participants indicated whether they were willing to uptake their selected service. The survey was advertised on MYDAWA's website; interested participants met staff in‐person at a convenient location to complete the survey from 1 June to 20 November 2022. We used conditional logit modelling with an interaction by current PrEP use to estimate overall preferences and latent class analysis (LCA) to assess preference heterogeneity. Results: Overall, 772 participants completed the DCE; the mean age was 25 years and 54% were female. Most participants indicated a willingness to acquire online PrEP services, with particularly high demand among PrEP‐naive individuals. Overall, participants preferred remote clinical consultation, HIV self‐testing, online self‐assessment and phone call user support. The LCA identified three subgroups: the "prefer online PrEP with remote components" group (60.3% of the sample) whose preferences aligned with the main analysis, the "prefer online PrEP with in‐person components" group (20.7%), who preferred in‐person consultation, provider‐administered HIV testing, and guided assessment, and the "prefer remote PrEP (18.9%)" group who preferred online PrEP services only if they were remote. Conclusions: Online pharmacy PrEP is highly acceptable and may expand PrEP coverage to those interested in PrEP but not accessing services. Most participants valued privacy and autonomy, preferring HIVST and remote provider interactions. However, when needing support for questions regarding PrEP, participants preferred phone/SMS contact with a provider. One‐fifth of participants preferred online PrEP with in‐person components, suggesting that providing multiple options can increase uptake. [ABSTRACT FROM AUTHOR]

Although it is an effective HIV prevention method, pre-exposure prophylaxis (PrEP) is underutilized in the Southern US. Many people who use drugs (PWUD) have increased susceptibility to HIV which could be lessened by using PrEP. Potential barriers to PrEP use include lack of awareness of PrEP, low knowledge about HIV prevention, low self-efficacy for HIV prevention, inaccurate risk perceptions, and anticipated stigma. The current study examined predisposing, enabling, and reinforcing factors that may predict interest in PrEP. The purpose of the current study was to explore factors associated with interest in and willingness to use daily oral and long acting injectable PrEP among sexually active adult PWUD. The data were collected from adult participants (n = 270) residing in Harris County, TX, who self-reported problematic substance use and who reported oral, anal, or vaginal sex in the six months prior to completing the survey. The survey was distributed and completed online via Qualtrics Panels in March of 2022 and included measures of PrEP and HIV knowledge, PrEP stigma, sexual health self-efficacy, experiences of discrimination, health literacy, and medical mistrust. The majority of participants reported circumstances or behaviors that increased their susceptibility to HIV. Findings indicated that PrEP user stereotypes and PrEP anticipated disapproval by others were associated with interest in using daily oral PrEP and willingness to use long acting injectable PrEP. These results provide insight into reasons for low PrEP uptake among PWUD who live in a high HIV prevalence jurisdiction. Implications for HIV prevention intervention are discussed. [ABSTRACT FROM AUTHOR]

National responses should be improved and accelerated to meet the target of ending the Acquired ImmunoDeficiency Syndrome (AIDS) epidemic by 2030. In the Republic of Cyprus, Men who have Sex with Men (MSM) are disproportionately affected by Human Immunodeficiency Virus (HIV), accounting approximately for half of all annual HIV diagnoses. This study assesses the evolution of HIV incidence in MSM in Cyprus until 2030 using a model calibrated to Cypriot epidemiological data. Four scenarios were examined: status quo, two scenarios focusing on introducing Pre-Exposure Prophylaxis (PrEP), and a 90% HIV incidence reduction scenario. Reaching only the 95-95-95 HIV cascade of care targets among MSM would reduce HIV incidence by 48.6% by 2030 compared to 2015. Initiating a PrEP intervention only for high risk MSM would cause a modest further reduction in HIV incidence. To meet the 90% reduction target, PrEP should be expanded to both high and medium risk MSM and, after 2025, behavioral interventions should be implemented so as high-risk MSM gradually move to the medium-risk category. Cyprus will not reach the HIV incidence reduction target by 2030 unless PrEP is gradually promoted and delivered to all high and medium risk MSM along with awareness and behavioral interventions. [ABSTRACT FROM AUTHOR]

Background. Mouthwash is a commonly used product with the potential to prevent STIs. This study aimed to determine the association between mouthwash use frequency with sexual behaviours and STIs among Chinese men who have sex with men (MSM). Methods. A cross-sectional study was conducted among MSM in Xi'an, China, from January to September 2022. Participants were categorised into non-mouthwash users, occasional (used it less than once every week) and frequent (used it more than once every week) mouthwash users. Multinomial logistic regression was performed to identify the association between mouthwash use frequency with sexual behaviours. Results. Of 838 MSM included in the analysis, 621 (74.11%) reported never using mouthwash, whereas 47 (5.60%) used it occasionally and 170 (20.29%) used it frequently. Frequent mouthwash users had a lower prevalence of chlamydia compared with occasional users (8.33% vs 23.93%, P < 0.05). In comparison with participants who consistently used condoms, those who used condoms occasionally and never used condoms were 1.8 (adjusted odds ratio (aOR) 1.838, 95% confidence interval (CI) 1.011-3.375) and 4.5 (aOR 4.538, 95% CI 1.259-16.362) times more likely to be frequent mouthwash users, respectively. Participants with more sexual partners who engaged in kissing (aOR 1.060, 95% CI 1.019-1.103), receptive oral sex (aOR 1.065, 95% CI 1.024-1.108), insertive oral sex (aOR 1.043, 95% CI 1.014-1.072) and receptive anal sex (aOR 1.076, 95% CI 1.027-1.127) were more likely to be frequent mouthwash users. Conclusion. MSM with more sexual partners or lower condom use frequency were more likely to be frequent mouthwash users. However, frequent mouthwash users had a lower chlamydia prevalence. [ABSTRACT FROM AUTHOR]

To improve current and future use of existing (oral, injectable) and potential future (implants, douches) pre-exposure prophylaxis (PrEP) products, we must understand product preferences relative to one another, among gay and bisexual men (GBM), and physicians who prescribe PrEP. We completed an online discrete choice experiment (DCE) with separate groups of GBM and/or physicians from the United States, South Africa, Spain, and Thailand. Participants were presented information on PrEP products, including daily pills, event-driven pills (2-1-1 regimen), injections, subdermal implants (dissolvable, removable), and rectal douches. Next, they completed a choice exercise in which they were shown 10 screens, each presenting 3 of the aforementioned products at a time with 11 attributes for physicians and 10 attributes for GBM. For the attributes that were not constant, one level was shown per screen for each product. Participants selected the product they preferred most and rated their likelihood to select (GBM) or recommend (physicians) that product. Data were modeled using hierarchical Bayes estimation; resulting model coefficients were used to develop attribute importance measures and product preferences. For GBM across all countries, if all aforementioned PrEP products were on the market at the same time, over 90% of GBM would use some form of PrEP; 100% of physicians would recommend at least one of the PrEP products. There were variations in product preference by country. GBM in the United States and Thailand preferred the injection (21.7%, 22.9%, respectively), while the dissolvable implant was preferred in South Africa and Spain (19.9%, 19.8%, respectively). In the United States, South Africa, and Spain (where physician data were available), physicians were most likely to recommend the dissolvable implant (37.2%, 40.6%, 38.3%, respectively). [ABSTRACT FROM AUTHOR]

Daily oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, though efficacy depends on adherence. Digital pill systems (DPS) can enable direct, real-time adherence measurement. HIV-negative men who have sex with men (MSM) with substance use (excluding alcohol) utilized a DPS over 90 days and completed weekly surveys reporting sexual activity, condom use, and substance use. Responses indicating (1) any sexual activity and substance use or (2) condomless anal intercourse (CAI) in the prior week were categorized as high risk for HIV acquisition. PrEP adherence data for the 7-day period preceding each response was dichotomized as ≤ 3 and ≥ 4 doses/week, indicating prevention-effective adherence, and compared by HIV risk level. Thirteen MSM were analyzed (median age: 32). Of 113 surveys, 48.7% indicated high HIV risk, with 12.4% reporting CAI alone, 16.8% any sexual activity and substance use, and 19.5% both CAI and substance use. Weekly mean PrEP adherence was 90.3% (6.3 of 7 doses/week), with ≥ 4 doses/week recorded during 92.0% of weeks. The proportion of participants with ≥ 4 recorded doses/week was 88.9% during weeks with CAI alone, 89.5% during weeks with any sexual activity and substance use, 92.0% during weeks with both CAI and substance use, and 92.8% during lower risk weeks. Participants ingested ≥ 4 doses/week during 89.1% of all high-risk weeks and 94.8% of low-risk weeks. Overall, participants maintained high levels of PrEP adherence while engaging in HIV risk behaviors. DPS can be deployed concurrently with data collection tools to assess ingestion patterns during periods of elevated risk. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP), including daily oral, on-demand, and long-acting injectable (LAI), is a promising HIV prevention intervention for men who have sex with men (MSM). We conducted a systematic review on engagement with the PrEP continuum among MSM in China. A total of 756 studies were initially identified and 36 studies were included (N = 26,021). In the 20 studies (N = 13,886) examining PrEP awareness, 32.4% (95% CI: 25.1–40.7) of MSM were aware of PrEP. In the 25 studies (N = 18,587) examining willingness, 54.5% (95% CI: 41.9–66.5) MSM indicated they were willing to use PrEP. The pooled prevalence of PrEP uptake from 9 studies (N = 6,575) was 4.9% (95% CI: 1.4–15.8%), while pooled estimates of adequate adherence from five studies (N = 2,344) among MSM on PrEP was 40.7% (95% CI: 20.0-65.2%). Subgroup analyses suggested studies conducted after 2015 (versus before) tended to report higher awareness and uptake. Awareness was highest for daily oral PrEP, followed by on-demand, and LAI PrEP; willingness to use was highest for LAI PrEP. The operationalization of willingness and adherence constructs varied across studies and complicated the interpretation of pooled estimates. This review revealed gaps in the PrEP care continuum among MSM in China, with relatively low awareness and uptake (in contrast to willingness and adherence) as the major potential barriers to widespread implementation and the need for a unified approach to defining and measuring PrEP outcomes. [ABSTRACT FROM AUTHOR]

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

We evaluated hair tenofovir (TFV) concentrations as an adherence metric for HIV preexposure prophylaxis during pregnancy and postpartum and compared hair levels with TFV-diphosphate levels in dried blood spots (DBSs). Overall 152 hair samples from 102 women and 36 hair-DBS paired samples from 29 women were collected from a subset of women in a cluster-randomized trial. Having a partner with HIV was associated with higher hair TFV levels (P <.001). Hair TFV concentrations were strongly correlated with DBS TFV-diphosphate levels (r = 0.76, P <.001), indicating hair as a promising cumulative adherence metric for perinatal preexposure prophylaxis assessment. [ABSTRACT FROM AUTHOR]

Background: The 2022 mpox outbreak continues, and while progress has been made in prevention strategies and potential treatment options, data on late sequelae following mpox are scarce. Objective: This analysis aimed to assess the incidence of scar formation in individuals affected by the 2022 mpox outbreak. Methods: All individuals diagnosed with mpox at the Department of Dermatology at the Medical University of Vienna in 2022 were included in this analysis. Follow‐up data were collected throughout November 2023. 'Scar formation' was defined as having at least one scar at the former active mpox lesions. Results: At our clinic, 28 cases of mpox presented between June 2022 and October 2022 and exclusively occurred in men who have sex with men (100%, 28/28), of whom 46% (13/28) were living with HIV, and 32% (9/28) were using pre‐exposure prophylaxis (PrEP). Secondary bacterial infection of mpox lesions was suspected in six individuals, and all received systemic antibiotics. Overall, 26 were followed up in November 2023 after a median time of 15 months, and scar formations were found in 43% of cases. Conclusions: Our data provide insights into the late yet cumulating disease burden caused by the 2022 mpox outbreak. Highly effective prevention strategies are warranted to overcome the mpox epidemic and its potential late sequelae. [ABSTRACT FROM AUTHOR]

PURPOSE HIV pre-exposure prophylaxis (PrEP) may increase rates of bacterial sexually transmitted infections (STIs) among gay, bisexual, and other men who have sex with men (GBM) through risk compensation (eg, an increase in condomless sex or number of partners); however, longitudinal studies exploring the time-dependent nature of PrEP uptake and bacterial STIs are limited. We used marginal structural models to estimate the effect of PrEP uptake on STI incidence. METHODS We analyzed data from the iCruise study, an online longitudinal study of 535 Ontarian GBM from July 2017 to April 2018, to estimate the effects of PrEP uptake on incidence of self-reported bacterial STIs (chlamydia, gonorrhea, and syphilis) collected with 12 weekly diaries. The incidence rate was calculated as the number of infections per 100 person-months, with evaluation of the STIs overall and individually. We used marginal structural models to account for time-varying confounding and quantitative bias analysis to evaluate the sensitivity of estimates to nondifferential outcome misclassification. RESULTS Participating GBM were followed up for a total of 1,623.5 person-months. Overall, 70 participants (13.1%) took PrEP during the study period. Relative to no uptake, PrEP uptake was associated with an increased incidence rate of gonorrhea (incidence rate ratio = 4.00; 95% CI, 1.67-9.58), but not of chlamydia or syphilis, and not of any bacterial STI overall. Accounting for misclassification, the median incidence rate ratio for gonorrhea was 2.36 (95% simulation interval, 1.08-5.06). CONCLUSIONS We observed an increased incidence rate of gonorrhea associated with PrEP uptake among Ontarian GBM that was robust to misclassification. Although our findings support current guidelines for integrating gonorrhea screening with PrEP services, additional research should consider the long-term impact of PrEP among this population. [ABSTRACT FROM AUTHOR]

Although perception of stigma (PS) has been dubbed as a key barrier to the optimal uptake of PrEP, research on PS is sparse. More specifically, no scholarly work has explored factors associated with the expression of PS toward PrEP use. This study addresses the literature gap by investigating factors associated with PS toward PrEP use. Data were drawn from the baseline survey (2017–2019) of the "Keeping It LITE Study", involving a large cohort (n = 3330) of young sexual minority men, transgender men and women, and non-binary individuals in the US. Participants' ages ranged from 13 to 34 years, with the majority (87%) assigned male at birth. The racial composition of the sample was diverse, with 53.9% identifying as white, 19.8% as Latinx, 10.7% as Black or African American, and smaller proportions as Asian, American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, and another race/ethnicity. Logistic regression models were utilized to examine two common measures of PS in PrEP use: (1) the perception that PrEP users are seen as promiscuous and (2) the perception that PrEP users are assumed to be HIV-positive. Two sets of models were developed to account for the correlation between gender identity and sex assigned at birth. The results suggest strong PS among current PrEP users, which can explain the weak PrEP adherence reported among this group. The findings underscore the need for targeted interventions to mitigate PS and enhance PrEP uptake and adherence in vulnerable populations. Social and practical implications of the results and directions for future research are discussed. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP) is a highly effective tool to prevent HIV, yet it is underutilized among women. The current study aims to evaluate the awareness, attitudes, and perceptions of PrEP among a large survey sample of Black and Latina women in New York City (NYC). Interviewer-administered surveys were conducted in high HIV incidence neighborhoods in NYC among Black, Latina, and Afro-Latina women who reported recent sex with a man in 2017 (n = 398) and 2018 (n = 405). About 40% of participants were aware of PrEP, whereas 30.4% indicated interest in using it. The top reason for not utilizing it was low HIV risk perception. However, most participants supported the idea that using PrEP meant asserting control over their health (94.1%). Primary care providers and obstetricians/gynecologists were participants' preferred sources for PrEP (91.6%). Across survey cycles, compared to non-Black Latina participants, Black participants had significantly higher PrEP awareness (44.4% vs. 29.1%). PrEP awareness was also significantly higher among survey participants in 2018 (45.2%) than in 2017 (34.3%). Less than half of the participants were aware of PrEP, but those who were aware expressed largely positive attitudes toward the medication. Our findings may inform future PrEP implementation strategies to optimize awareness and access to PrEP among women disproportionately affected by HIV, like focusing on personal empowerment instead of risk-based messaging and training women's sexual health care providers in PrEP provision. [ABSTRACT FROM AUTHOR]

Sexual minority men (SMM) who experience intimate partner violence (IPV) may also be at increased risk for HIV; however, little is known about the relationship between these experiences and the utilization of pre-exposure prophylaxis (PrEP) for HIV prevention. This systematic review aimed to synthesize available literature to examine the complex interplay between IPV experiences and engagement in the PrEP care continuum among SMM. A comprehensive search following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines in Embase, PubMed, PsycINFO, Web of Science, Medline, and CINAHL identified only 13 relevant articles, most of which were conducted in the United States (n = 9) and only two in low- and middle-income countries (LMICs). Nearly all studies (n = 12, 92.3%) were quantitative in design and used cross-sectional data. The findings of this review identified critical gaps in measuring IPV and PrEP outcomes and revealed mixed findings regarding the complex interplay between IPV and PrEP care engagement in the context of syndemics experienced by SMM. The results highlight the critical need for future research to understand the impact of IPV on PrEP uptake and adherence and its underlying mechanisms. This includes investigating the effects of different types of IPV (e.g., emotional, physical, sexual) on PrEP utilization and how these experiences influence PrEP preferences, such as daily PrEP versus on-demand PrEP or long-acting injectable PrEP. The implications of this review call for comprehensive public health policies and integrated health care practices that provide tailored interventions for IPV screening in PrEP care settings to deliver IPV services and promote engagement in the PrEP care continuum among SMM, as well as further investigation in LMICs. [ABSTRACT FROM AUTHOR]

Long-acting injectable cabotegravir (CAB-LA) was US Food and Drug Administration--approved in 2021. However, little is known about providers' CAB-LA knowledge, attitudes, challenges, and prescribing preferences for transgender women patients. Understanding this is critical to developing new pre-exposure prophylaxis (PrEP) interventions tailored to transgender women. We conducted 45-min, in-depth Zoom interviews (IDIs) with United States--based health care providers who prescribe PrEP to transgender women. IDIs focused on providers' CAB-LA knowledge/acceptability, willingness to prescribe CAB-LA to transgender women, potential challenges, and solutions to mitigate challenges. Providers (N517) had a mean age of 43 years, and 35.4% (n56) identified as people of color. Most (n = 12) had basic knowledge of CAB-LA but wanted additional training. All participants found CAB-LA acceptable and were willing to prescribe. Most (n = 11) anticipated minimal challenges to implementation. Others (n = 4) reported potential issues, including logistical/scheduling concerns that impede CAB-LA integration and staffing concerns. Many providers expressed support for self-injection (n = 13) and injections at "drop-in" clinics (n = 8) to overcome challenges. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP) availability through the Pharmaceutical Benefits Scheme provides real potential for the elimination of HIV transmission in Australia, as evidenced by a rapid decline in HIV incidence among gay and bisexual men (GBM). However, HIV elimination will not be possible without also extending PrEP to other populations, including cisgender women. We conducted a scoping review to examine the extent to which PrEP access for cisgender women has been considered in Australia. A comprehensive search across five databases, grey literature, and hand search of references was conducted. A single reviewer conducted title and abstract screening and two reviewers completed full-text screening and data extraction. Nineteen documents were included in the final review and included both peer-reviewed journal articles and guidelines and strategies. Focused discussion of cisgender women's use of PrEP was largely missing from the literature and, although their use of PrEP is supported in some relevant guidelines, little has been done to actively develop strategies to inform cisgender women about PrEP as a precursor to prescribing for HIV prevention. Healthcare providers' narrow view of PrEP as being the domain of GBM further limits cisgender women's potential access. If HIV elimination in Australia is to be a reality, we need to develop mechanisms to specifically engage with cisgender women about PrEP. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission, but uptake and adherence among young men who have sex with men (YMSM) remains suboptimal. New PrEP formulations may enhance PrEP use, but little is known about their acceptability. We enrolled 39 cis- and transgender YMSM (age 18–34) from Boston, MA; Jackson, MS; Birmingham, AL; and New Orleans, LA, who participated in video-based focus groups (n = 30) or in-depth interviews (n = 9) to examine how new PrEP products (e.g., injections, monthly pills, implants) are perceived and might be improved for YMSM. Focus groups were transcribed, coded, and analyzed using grounded theory and content analysis. Nearly half (46%) of participants were Black; 11% identified as Hispanic. Seventy-nine percent were PrEP experienced. Product preference was driven by the desire for flexible, safe, effective, and affordable PrEP options. A majority of participants preferred subcutaneous injections every 6 months or monthly pills dispersed in 3 or 4 doses. Subcutaneous injections and batched monthly pills were favored by those with demanding schedules and those who desired fewer provider visits; monthly pills were more appealing for those who feared needles. Despite broad preferences for longer-acting products for convenience, participants raised concerns regarding side effects and waning protection after missed doses. Participants felt that more education about safety and efficacy profiles of new products could influence their attitudes. These findings suggest that it is important to prioritize YMSM's dynamic lifestyles during product development, and that product safety and efficacy information should be accessible in youth-friendly language. [ABSTRACT FROM AUTHOR]

Latino sexual minority men (SMM) are a highly vulnerable population to HIV, and while pre-exposure prophylaxis (PrEP) has emerged as a promising biomedical tool for HIV prevention among them, its utilization remains disproportionately low in this community despite its potential. Understanding the barriers along the PrEP continuum of care, known as the "PrEP cascade," is crucial for effectively implementing PrEP interventions. Therefore, the objective of our study was twofold: first, to explore the stage of Latino SMM in the PrEP cascade by examining disparities in demographics, social factors, and healthcare aspects; second, to gain insights from healthcare providers who have direct clinical experience with our population regarding the challenges faced by Latino SMM in accessing and adhering to PrEP. Based on the study findings, the majority of participants (n = 74; 49%) were in the contemplation stage, and only one in ten Latino SMM (10.6%) were currently adherent to PrEP. Compared to those who were at least second-generation, first-generation status had a positive association (B = 0.699, SE = 0.208, β = 0.351, p <.001) with engagement along the PrEP Contemplation Ladder. Conversely, having at least one parent who did not have legal residency, relative to those whose parents were both U.S. citizens or held legal residency documentation, was found to have a negative association (B = − 0.689, SE = 0.245, β = 0.245, p =.006) with engagement along the PrEP Contemplation Ladder. Additionally, discussing PrEP with a healthcare provider had a positive association (B = 0.374, SE = 0.179, β = 0.185, p =.038) with engagement along the PrEP Contemplation Ladder. Qualitative results from our study suggest that some Latinos who initially agreed to start using PrEP ended up getting lost in the care pipeline and failed to attend their scheduled appointments. Providers also noted that many patients lacked access to a pharmacy where they felt comfortable obtaining their PrEP prescription, leading them to discontinue use after only a few months. These findings emphasize the importance of considering the unique needs, culture, and background of Latinos, including care delivery and provider attitudes that can facilitate progress through the PrEP cascade. [ABSTRACT FROM AUTHOR]

Abstract Background The social distancing measures associated with the COVID-19 pandemic had far reaching effects on sexual behavior worldwide. However, it remains unclear whether sexual contact with non-steady partners was a contributor to the spread of SARS-CoV-2. The aim of this study was to (i) describe risk factors for SARS-CoV-2 seropositivity after the first pandemic wave among people using HIV Pre-Exposure Prophylaxis (PrEP) in Zurich, Switzerland, including sexual contact with non-steady partners, and (ii) assess whether the SARS-CoV-2 seropositivity among PrEP users in this time period differed from that of a demographic matched population level comparison group. Methods The study was conducted between July 2020 and October 2020 as a nested cross-sectional study within two ongoing cohort studies, SwissPrEPared (all eligible PrEP users in Switzerland ≥ 18 years old) and Corona Immunitas (a series of cross-sectional and longitudinal studies measuring the SARS-CoV-2 seroprevalence across Switzerland, beginning in April 2020). All SwissPrEPared participants were recruited from Checkpoint Zurich (the main PrEP clinic in Zurich) and were men having sex with men or transgender women. Data were collected on participants’ SARS-CoV-2 antibody status, social characteristics and behavioral data after the first wave of the pandemic in Switzerland, and seroprevalence was compared with a propensity score-matched sample from the general Zurich population. Results Of the 218 participants enrolled, 8.7% (n = 19, 95% CI: 5.5–13.5%) were seropositive for SARS-CoV-2 during the first pandemic wave, higher than that of the general male population in Zurich aged 20–65 (5.5%, 95% CI: 3.8–8.2%). Participants on average reduced their social outings, but the seronegative were more socially active before, during, and after the first lockdown period. In a logistic model, increasing mean sexual partner count was not associated with seropositivity (OR: 1.02, 95% CI: 0.95, 1.07). The estimated risk ratio for seropositivity for the participants compared to the general Zurich population after propensity score matching was 1.46 (95% CI: 0.53, 3.99). Conclusions Our study suggests that SARS-CoV-2 seropositivity was slightly elevated among people taking PrEP in Zurich during the first wave of the pandemic, but that socializing and sexual activity were less important than other factors in contributing to risk.

Abstract Background In Africa, dispensing oral HIV pre-exposure prophylaxis (PrEP) within already strained public health facilities has led to prolonged waiting periods and suboptimal experiences for clients. We sought to explore the acceptability of dispensing PrEP semiannually with interim HIV self-testing (HIVST) versus quarterly PrEP dispensing with clinic-based HIV testing to optimize clinic-delivered PrEP services. Methods We conducted a qualitative study within a non-inferiority individual-level randomized controlled trial testing the effect of six-monthly PrEP dispensing with HIVST compared to the standard-of-care three-monthly PrEP dispensing on PrEP clinical outcomes in Kenya (ClinicalTrials.gov: NCT03593629). Eligible participants were ≥ 18 years, refilling PrEP for the first time, and either in an HIV serodifferent relationship (men and women) or singly enrolled (women only). A subset of participants in the intervention group completed serial in-depth interviews (IDIs) at enrollment, six months, and 12 months. We utilized stratified purposive sampling to ensure representation across participant groups. We analyzed our qualitative data thematically using a combination of inductive and deductive approaches, the latter guided by the Theoretical Framework of Acceptability (TFA). Results Between May 2018 and June 2021, we conducted 120 serial IDIs with 55 participants; 64% (35/55) were in a serodifferent relationship, 64% (35/55) were women, and the median age was 32 years (IQR 27–40). Overall, participants found this novel PrEP delivery model highly acceptable; it was well-liked, private (TFA construct: affective attitude), and less burdensome (TFA construct: burden) compared to standard PrEP delivery. Additionally, participants were confident in their ability to participate in the intervention (TFA construct: self-efficacy). Some participants, however, highlighted model disadvantages, including fewer opportunities for in-person counseling and potentially less accurate HIV testing (TFA construct: opportunity costs). Ultimately, most participants reported that the intervention allowed them to achieve their HIV prevention goals (TFA construct: perceived effectiveness) and that their confidence in at-home HIVST and PrEP continuation increased following each semiannual clinic visit. Conclusions Semiannual PrEP clinic visits supported with six-monthly drug dispensing and interim HIVST was acceptable among PrEP users who experienced the intervention in Kenya. More comprehensive pre-intervention counseling and training on HIVST may help alleviate the client concerns presented, which were often resolved over time with intervention experience.

Abstract During the 2022 mpox outbreak, our study conducted 30 interviews with a recruited sample of Chicago gay men (age 18+) during June-September to investigate their experiences of mpox, HIV/AIDS, and COVID-19. Participants were interviewed with a semi-structured guide about gay sexual identity and social experiences; HIV/AIDS, ART, and PrEP; and COVID-19 behaviors and vaccination. All 30 interview respondents had been fully vaccinated for COVID-19 and expressed minimal COVID-19 vaccine hesitancy. All the men living with HIV in our study were on ART with HIV well controlled. A majority of HIV- participants (70%) were on PrEP, with participants universally aware of PrEP benefits. Additionally, most participants had already received at least one shot of the Jynneos mpox vaccine, with many interviewees enduring long lines, sometimes at multiple locations, before vaccination in primarily gay social spaces. These Chicago gay men demonstrated widespread enthusiasm for mpox vaccination as a disease prevention strategy and most of them had already been vaccinated despite significant barriers. The enthusiasm of the participants in our study emerged within a medical landscape shaped by both COVID-19 vaccination and HIV/AIDS-related health interventions including ART and PrEP, which may have helped instill increased medical trust among this population. Our study suggests that out urban gay men may comprise a distinctive minority population with increased medical trust due to specific social, sexual, and historical experiences.

HIV pre-exposure prophylaxis (PrEP) use is limited among male sex workers, who are at exceptionally high-risk for HIV infection. We developed a theory-informed, two-pronged intervention (PrEPare-for-Work) to optimize PrEP initiation and adherence among male sex workers, which was preliminarily evaluated in a two-stage pilot randomized controlled trial of 110 male sex workers in the US Northeast. Individuals randomized to the Stage 1 PrEPare-for-Work Case Management arm were three times as likely as those in the standard of care (SOC) arm to initiate PrEP (RR = 2.95, 95% CI = 1.57-5.57). Participants who initiated PrEP and were randomized to the Stage 2 PrEPare-for-Work Adherence Counseling arm had higher rates of prevention-effective adherence (measured via tenofovir in hair) compared to those in the SOC arm (RR = 1.7, 95% CI 0.64-4.77; 55.6% vs. 28.6%, respectively); though not statistically significant. Given the need and the promise of this pilot RCT, further efficacy testing is warranted and should be prioritized.

Supplemental Digital Content is Available in the Text. Background: Little is known about the efficacy of preexposure prophylaxis (PrEP) or what biologic factors may influence HIV transmission in transgender men (TGM). In this study, we sought to explore the effect of testosterone on the vaginal microbiome, cervicovaginal fluid (CVF) tenofovir concentrations, and levels of CVF inflammatory markers in TGM on PrEP. Methods: Cervicovaginal fluid was collected from 13 TGM (7 using testosterone) and 32 cisgender women (CGW) on PrEP. The vaginal microbiome, CVF tenofovir concentrations, and CVF inflammatory markers were determined and compared. Results: The proportion of CVF Lactobacillus was significantly higher in CGW than in TGM (78% vs 24%, P < 0.001). Among TGM, the proportion of CVF Lactobacillus was lower, though not statistically significant, in those taking testosterone than in those not taking testosterone (14% vs 35%, P -value = 0.3). Interestingly, mean CVF tenofovir concentrations were the lowest in TGM on testosterone at 884 ng/mL compared with 3150 ng/mL in TGM not on testosterone and 1932 ng/mL in CGW; however, this difference was not statistically significant. There was no statistically significant difference in any of the genital inflammatory markers between groups and no correlation between inflammation and tenofovir levels. Conclusions: Our findings suggest a potential correlation between testosterone use, Lactobacillus dominance, and lower TFV concentrations in CVF, which may have implications on HIV acquisition from vaginal sex in TGMT. Future studies with larger sample sizes are needed to further investigate these relationships. [ABSTRACT FROM AUTHOR]

Background: We assessed access to pre-exposure prophylaxis (PrEP) and interest in integration of PrEP with gender-affirmative care in a global sample of transmasculine persons. Methods: Transmasculine persons (N = 590) aged 18 years and above from 57 countries completed a brief online survey from April to July 2022 about sexual behavior, knowledge, and interest in PrEP, current access to PrEP and gender-affirmative care, and preferred context for accessing PrEP. Descriptive analyses were stratified by country income group. Results: Most participants (54.4%) lived near a health center offering care to trans people. Overall, 1.9% of respondents reported ever receiving a positive HIV test result. Among those who had not (n = 579), more than a third reported engaging in receptive sex in the past year (35.2%) or anticipated doing so in the next year (41.5%), 86.9% had never received information about HIV prevention specific to transmasculine people, and 76.3% had heard of PrEP. Among those who had heard of PrEP (n = 440), only 18.9% had discussed or been offered it by a provider, and only 3.6% were currently taking it—yet 67.9% who had heard of it but were not using it would "definitely" (28.5%) or "maybe" (39.4%) be interested in taking it were it available for free. Out of these participants, the majority (60.5%) preferred the idea of accessing PrEP from the same clinic where they received gender-affirming care. Conclusions: Interventions are needed to improve PrEP access for transmasculine people globally. Clinics already providing gender-affirming care to trans people are acceptable clinical contexts to integrate such interventions. [ABSTRACT FROM AUTHOR]