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BackgroundOral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings.MethodsHIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentrations in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies.ResultsAmong 17 274 participants, there were 101 cases with new HIV-1 diagnosis (.77 per 100 person-years; 95% confidence interval [CI]: .63-.94). In 78 cases with resistance data, 18 (23%) had M184I or V, 1 (1.3%) had K65R, and 3 (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of

BackgroundIntimate partner violence (IPV) is associated with increased risk of HIV acquisition and reduced engagement in HIV care. There is limited understanding of the ways in which IPV exposure and other maladaptive relationship dynamics may influence adherence to antiretroviral treatment (ART) and pre-exposure prophylaxis (PrEP) for individuals in committed, HIV serodifferent partnerships.MethodsWe used binomial generalized linear mixed effect regression models to evaluate the association between IPV exposure and ART/PrEP adherence among members of serodifferent couples in Uganda. Secondarily, we assessed the association between relationship powerlessness and ART/PrEP adherence.ResultsWe enrolled and followed both partners in 149 heterosexual serodifferent couples. The partner living with HIV was female in 64% of couples. IPV exposure was associated with low ART adherence (15% vs. 5% in quarters with no IPV, odds ratio [OR]: 4.78, 95% confidence interval [CI] 1.48 - 15.42) but not low PrEP adherence (33% vs. 36%, p=0.69). Among HIV-negative individuals, those reporting moderate relationship powerlessness were less likely to have poor PrEP adherence compared to those with low relationship powerlessness (20% vs. 30%, OR: 0.57, 95% CI 0.36 - 0.90). We observed no association between relationship powerlessness and ART adherence.ConclusionsWe found that IPV exposure was associated with low adherence to ART and that relationship powerlessness was associated with good adherence to PrEP. These findings contribute to the evidence base outlining the influence of IPV and relationship power on ART/PrEP adherence for individuals in HIV serodifferent unions.

Appointment keeping and self-report within 7-day or and 30-days recall periods are non-objective measures of antiretroviral treatment (ART) adherence. We assessed incidence of virological failure (VF), predictive performance and associations of these adherence measures with VF among adults on long-term ART. Data for persons initiated on ART between April 2004 and April 2005, enrolled in a long-term ART cohort at 10-years on ART (baseline) and followed until December 2021 was analyzed. VF was defined as two consecutives viral loads ≥1000 copies/ml at least within 3-months after enhanced adherence counselling. We estimated VF incidence using Kaplan-Meier and Cox-proportional hazards regression for associations between each adherence measure (analyzed as time-dependent annual values) and VF. The predictive performance of appointment keeping and self-reporting for identifying VF was assessed using receiver operating characteristic curves and reported as area under the curve (AUC). We included 900 of 1,000 participants without VF at baseline: median age was 47 years (Interquartile range: 41-51), 60% were women and 88% were virally suppressed. ART adherence was ≥95% for all three adherence measures. Twenty-one VF cases were observed with an incidence rate of 4.37 per 1000 person-years and incidence risk of 2.4% (95% CI: 1.6%-3.7%) over the 5-years of follow-up. Only 30-day self-report measure was associated with lower risk of VF, adjusted hazard ratio (aHR) = 0.14, 95% CI:0.05-0.37). Baseline CD4 count ≥200cells/ml was associated with lower VF for all adherence measures. The 30-day self-report measure demonstrated the highest predictive performance for VF (AUC = 0.751) compared to appointment keeping (AUC = 0.674), and 7-day self-report (AUC = 0.687). The incidence of virological failure in this study cohort was low. Whilst 30- day self-report was predictive, appointment keeping and 7-day self-reported adherence measures had low predictive performance in identifying VF. Viral load monitoring remains the gold standard for adherence monitoring and confirming HIV treatment response.

“When elephants fight, it is the grass that suffers”—African proverb The Uganda Anti‐Homosexuality Act 2023 (AHA) has had a detrimental impact on vulnerable Ugandans. Since its enactment, the AHA has [...]

: Introduction: Adherence counselling with point‐of‐care (POC) drug‐level feedback using a novel tenofovir assay may support pre‐exposure prophylaxis (PrEP) adherence; however, perceptions of urine testing and its impact on adherence are not well studied. We qualitatively examined how POC tenofovir testing was experienced by transgender women (TGW) in Uganda. Methods: Within a cluster randomized trial of peer‐delivered HIV self‐testing, self‐sampling for sexually transmitted infections and PrEP among HIV‐negative TGW showing overall low PrEP prevention‐effective adherence (NCT04328025), we conducted a nested qualitative sub‐study of the urine POC assay among a random sample of 30 TGW (August 2021−February 2022). TGW interviews explored: (1) experiences with POC urine tenofovir testing and (2) perceptions of PrEP adherence counselling with drug‐level feedback. We used an inductive content analytic approach for analysis. Results: Median age was 21 years (interquartile range 20–24), and 70% engaged in sex work. Four content categories describe how TGW experienced POC urine tenofovir testing: (1) Urine tenofovir testing was initially met with scepticism: Testing urine to detect PrEP initially induced anxiety, with some perceptions of being intrusive and unwarranted. With counselling, however, participants found POC testing acceptable and beneficial. (2) Alignment of urine test results and adherence behaviours: Drug‐level feedback aligned with what TGW knew about their adherence. Concurrence between pill taking and tenofovir detection in urine reinforced confidence in test accuracy. (3) Interpretation of urine tenofovir results: TGW familiar with the interpretation of oral‐fluid HIV self‐tests knew that two lines on the test device signified positivity (presence of HIV). However, two lines on the urine test strip indicated a positive result for non‐adherence (absence of tenofovir), causing confusion. Research nurses explained the difference in test interpretation to participants’ satisfaction. (4) White coat dosing: Some TGW deliberately chose not to attend scheduled clinic appointments to avoid detecting their PrEP non‐adherence during urine testing. They restarted PrEP before returning to clinic, a behaviour called “white coat dosing.” Conclusions: Incorporating POC urine testing into routine PrEP adherence counselling was acceptable and potentially beneficial for TGW but required attention to context. Additional research is needed to identify effective strategies for optimizing adherence monitoring and counselling for this population., INTRODUCTION Transgender women (TGW), who are biologically assigned male at birth but identify as female, face a significant burden of HIV in East and Southern Africa. The reported prevalence of [...]

New tools are needed to support PrEP adherence for individuals at risk for HIV, including those that enable provision of real-time feedback. In a large, completed PrEP trial, adequate urine tenofovir levels measured by a novel immunoassay predicted HIV protection and showed good sensitivity and specificity for detectable plasma tenofovir.

Introduction: Distribution of HIV self-testing (HIVST) kits through MSM peer networks is a novel and effective strategy to increase HIV testing coverage in this high-risk population. No study has evaluated the cost or cost effectiveness of peer distribution of HIVST strategies among MSM in sub-Saharan Africa. Methods: From June to August 2018, we conducted a pilot study of secondary MSM peer HIVST kit distribution at The AIDS Support Organization at Entebbe and Masaka. We used an ingredients approach to estimate the cost of MSM peer HIVST kit distribution relative to standard-of-care (SOC) hotspot testing using programme expenditure data reported in US dollars. The provider perspective was used to estimate incremental cost-effective ratios per HIV infection averted using the difference in HIV annual transmission rates between MSM with HIV who knew their status and were not virologically suppressed and MSM with HIV who did not know their status. Results: We enrolled 297 participants of whom 150 received MSM peer HIVST kit distribution (intervention group) and 147 received TASO standard of care HIV testing (control group). Provider cost for the intervention was $2,276 compared with $1,827 for SOC during the 3-month study period. Overall, the intervention resulted in higher HIV positivity yield (4.9 vs. 1.4%) and averted more HIV infections per quarter (0.364 vs. 0.104) compared with SOC. The cost per person tested was higher for the intervention compared to SOC ($15.90 vs. $12.40). Importantly, the cost per new HIV diagnosis ($325 vs. $914) and cost per transmission averted ($6,253 vs. $ 17,567) were lower for the intervention approach relative to SOC. The incremental cost per HIV transmission averted by the self-testing program was $1,727. The incremental cost to providers per additional HIV-positive person identified by the intervention was $147.30. Conclusion: The intervention strategy was cost-effective, and identified more undiagnosed HIV infections than SOC hotspot testing at a cost-effectiveness threshold of US $2,129. Secondary distribution of HIVST kits through peers should further be evaluated with longer duration aimed at diagnosing 95% of all persons with HIV by 2030; the first UNAIDS 95-95-95 target.

Pregnancy is a high-risk period for HIV acquisition in African women, and pregnant women who become acutely infected with HIV account for up to a third of vertical HIV transmission cases in African settings. To protect women and eliminate vertical transmission, WHO recommends offering oral pre-exposure prophylaxis (PrEP) based on tenofovir to HIV-negative pregnant and post-partum women with a substantial risk of HIV acquisition. PrEP implementation for pregnant and post-partum women lags behind implementation for other high-risk populations. Unique considerations for PrEP implementation arise during pregnancy and post partum, including the integration of provider training with clinical delivery and monitoring of PrEP exposure and outcomes within existing maternal health systems, yet scarce implementation data are available to generate evidence in this context.

: Introduction: Peer delivery is a client‐centred approach that could maximize the coverage and impact of HIV services for transgender women (TGW). We conducted qualitative interviews to examine how peer‐delivered HIV self‐testing (HIVST), sexually transmitted infection self‐sampling (STISS) and oral pre‐exposure prophylaxis (PrEP) influenced prevention choices among TGW and their intimate partners in Uganda. Methods: Within a cluster randomized trial of peer‐delivered HIVST, STISS and PrEP among HIV‐negative TGW (NCT04328025), we conducted 55 qualitative interviews with 30 TGW, 15 intimate partners and 10 TGW peers (August 2021–February 2022). TGW interviews explored: (1) HIV self‐test and PrEP experiences; (2) HIVST with intimate partners; and (3) descriptions of self‐sampling for STI testing. Partner interviews covered: (1) experiences with HIVST; (2) disclosure of HIV status to intimate partner; and (3) descriptions of sexual behaviours after testing. Peer interview topics included: (1) intervention delivery experiences; and (2) recommendations for peer‐delivered HIV prevention services to TGW, including psychological support and coping strategies. Qualitative data were analysed using an inductive content analytic approach. Results: Peer‐delivered combination prevention was valued by this group of TGW and their partners. (1) Peer services extended beyond delivering HIV/STI kits and PrEP refills to caring for individual health and wellbeing by providing stigma coping strategies. Peer psychosocial support empowered research participants to become “HIVST ambassadors,” teach non‐study TGW about self‐testing and PrEP, and encourage linkage to care. (2) HIVST with intimate partners and mutual disclosure of HIV status strengthened partnered relationships. PrEP use after both partners tested HIV negative implied infidelity. (3) Self‐sampling enabled TGW to take control of their STI testing and avoid the embarrassment of exposing their bodies. Privacy and confidentiality motivated the uptake of STI testing and treatment. Conclusions: In this sample of TGW from Uganda, peer delivery of HIVST, STISS and PrEP refills benefitted individual prevention efforts and extended to a new linkage of TGW not engaged in care. Integrating peer services into differentiated PrEP delivery could increase HIV/STI test coverage and PrEP use in this vulnerable population., INTRODUCTION Globally, transgender women (TGW; people who are assigned male sex at birth but identify as female) are 14 times as likely to be living with HIV as other women [...]

IntroductionOne-in-three men who have sex with men (MSM) in Uganda have never tested for HIV. Peer-driven HIV testing strategies could increase testing coverage among non-testers. We evaluated the yield of peer distributed HIV self-test kits compared with standard-of-care testing approaches in identifying undiagnosed HIV infection.MethodsFrom June to August 2018, we conducted a pilot study of secondary distribution of HIV self-testing (HIVST) through MSM peer networks at The AIDS Support Organization (TASO) centres in Entebbe and Masaka. Peers were trained in HIVST use and basic HIV counselling. Each peer distributed 10 HIVST kits in one wave to MSM who had not tested in the previous six months. Participants who tested positive were linked by peers to HIV care. The primary outcome was the proportion of undiagnosed HIV infections. Data were analysed descriptively.ResultsA total of 297 participants were included in the analysis, of whom 150 received HIVST (intervention). The median age of HIVST recipients was 25 years (interquartile range [IQR], 22-28) compared to 28 years IQR (25-35) for 147 MSM tested using standard-of-care (SOC) strategies. One hundred forty-three MSM (95%) completed HIVST, of which 32% had never tested for HIV. A total of 12 participants were newly diagnosed with HIV infection: 8 in the peer HIVST group and 4 in the SOC group [5.6% vs 2.7%, respectively; P = 0.02]. All participants newly diagnosed with HIV infection received confirmatory HIV testing and were initiated on antiretroviral therapy.ConclusionPeer distribution of HIVST through MSM networks is feasible and effective and could diagnose more new HIV infections than SOC approaches. Public health programs should consider scaling up peer-delivered HIVST for MSM.

IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.

IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.

: Introduction: Secondary distribution of HIV self‐tests (HIVST) by HIV‐negative pregnant women to male partners increases men's testing rates. We examined whether this strategy promotes male partner testing for pregnant women living with HIV (PWLHIV). Methods: We conducted an open‐label individually randomized trial in Kampala, Uganda, in which PWLHIV ≥18 years who reported a partner of unknown HIV status were randomized 2:1 to secondary distribution of HIVST for male partner(s) or standard‐of‐care (SOC; invitation letter to male partner for fast‐track testing). Women were followed until 12 months post‐partum. Male partners were offered confirmatory HIV testing and facilitated linkage to antiretroviral treatment (ART) or oral pre‐exposure prophylaxis (PrEP). Using intention‐to‐treat analysis, primary outcomes were male partner testing at the clinic and initiation on PrEP or ART evaluated through 12 months post‐partum (ClinicalTrials.gov, NCT03484533). Results: From November 2018 to March 2020, 500 PWLHIV were enrolled with a median age of 27 years (interquartile range [IQR] 23–30); 332 were randomized to HIVST and 168 to SOC with 437 PWLHIV (87.4%) completing 12 months follow‐up post‐partum. Of 236 male partners who tested at the clinic and enrolled (47.2%), their median age was 31 years (IQR 27–36), 45 (88.3%) men with HIV started ART and 113 (61.1%) HIV‐negative men started PrEP. There was no intervention effect on male partner testing (hazard ratio [HR] 1.04; 95% confidence interval [CI]: 0.79–1.37) or time to ART or PrEP initiation (HR 0.96; 95% CI: 0.69–1.33). Two male partners and two infants acquired HIV for an incidence of 0.99 per 100 person‐years (95% CI: 0.12–3.58) and 1.46 per 100 person‐years (95% CI: 0.18%–5.28%), respectively. Social harms related to study participation were experienced by six women (HIVST = 5, SOC = 1). Conclusions: Almost half of the partners of Ugandan PWLHIV tested for HIV with similar HIV testing rates and linkage to ART or PrEP among the secondary distribution of HIVST and SOC arms. Although half of men became aware of their HIV serostatus and linked to services, additional strategies to reach male partners of women in antenatal care are needed to increase HIV testing and linkage to services among men., INTRODUCTION Pregnant women living with HIV (PWLHIV) are more likely to achieve viral suppression (VS) and complete the prevention of mother‐to‐child HIV transmission (PMTCT) cascade when their partners are tested [...]

Introduction: HIV self-testing (HIVST) and oral pre-exposure prophylaxis (PrEP) are complementary, evidence-based, self-controlled HIV prevention tools that may be particularly appealing to sex workers. Understanding how HIVST and PrEP are perceived and used by sex workers and their intimate partners could inform prevention delivery for this population. We conducted qualitative interviews to examine ways in which HIVST and PrEP use influence prevention choices among sex workers in Uganda. Methods: Within a randomized trialof HIVST and PrEP among 110 HIV-negative cisgender women, cisgender men and trans-gender women sex workers (NCT03426670), we conducted 40 qualitative interviews with 30 sex workers and 10 intimate partners (June 2018 to January 2020). Sex worker interviews explored (a) experiences of using HIVST kits; (b) how HIVST was performed with sexualpartners; (c) impact of HIVST on PrEP pilltaking; and (d) sexualrisk behaviours after HIVST Partner interviews covered (i) introduction of HIVST; (ii) experiences of using HIVST; (iii) HIV status disclosure; and (iv) HIVST's effect on sexualbehaviours. Data were analysed using an inductive content analytic approach centering on descriptive category development. Together, these categories detailthe meaning of HIVST and PrEP for these qualitative participants. Results: Using HIVST and PrEP was empowering for this group of sex workers and their partners. Three types of empowerment were observed: (a) economic; (b) relational; and (c) sexualhealth. (i) Using HIVST and PrEP made sex without condoms safer. Sex workers could charge more for condomless sex, which was empowering economically. (ii) Self-testing restored trust in partners' fidelity upon being reunited after a separation. This trust, in combination with condomless sex made possible by PrEP use, restored intimacy, empowering partnered relationships. (iii) HIVST and PrEP enabled sex workers to take control of their HIV prevention efforts and avoid the stigma of public clinic visits. In this way they were empowered to protect their sexualhealth. Conclusions: In this sample, sex workers' use of HIVST and PrEP benefitted not only prevention efforts, but also economic and relational empowerment. Understanding these larger benefits and communicating them to stakeholders could strengthen uptake and use of combination prevention interventions in this marginalized population. Keywords: Africa; empowerment; HIV prevention; HIV self-testing; pre-exposure prophylaxis; sex workers, 1 | INTRODUCTION Worldwide, transgender and female sex workers (SW) are 48.8 and 13.5 times more likely to be living with HIV than other women of reproductive age, respectively [1,2]. [...]

Introduction: Training in care for sexual and gender minority (SGM) populations is critical for ending the HIV epidemic. SGM people, particularly men who have sex with men (MSM) and transgender women, experience disproportionate HIV infection across the globe. The objective of this commentary was to synthesize facilitators of and barriers to SGM health training efforts for healthcare workers in Uganda, in order to help inform potential priorities, strategies and next steps to advance culturally responsive HIV-related care for SGM communities across Uganda and sub-Saharan Africa. Discussion: SGM health training often includes education on: foundational concepts and language; stigma, discrimination and SGM health disparities; understanding and addressing implicit bias; sensitive and effective communication and building SGM-inclusive and welcoming healthcare environments. Clinicians' education includes sexual and gender histories, sex-positive HIV counselling, sexually transmitted infections, HIV pre-exposure prophylaxis and gender-affirming hormone therapy. SGM communities in sub-Saharan Africa have often experienced discrimination, persecution, incarceration and physical violence, and they encounter unique barriers to engagement in sexual health services and HIV prevention and treatment. SGM health training efforts in Uganda reveal challenges to and opportunities for advancing equity for SGM communities in sexual health and HIV medical care across the region. In Uganda, SGM community advocacy, as well as policies and programmes of the Ministry of Health and US President's Emergency Plan for AIDS Relief, have increased readiness and need for scaling up training and skills-sharing in SGM-focused HIV and sexual healthcare, including Ugandan-led and international initiatives. Conclusions: Numerous challenges exist to widespread culturally responsive HIV and sexual healthcare for SGM communities in sub-Saharan Africa. Lessons learned from healthcare worker training efforts in Uganda may inform future replication, adaptation and dissemination initiatives to meet the needs of more SGM communities in the region. Evaluation of SGM health training programmes to determine the impact on HIV virological suppression and sexual health outcomes will be critical for identifying best practices and strategies that may support advancing HIV epidemic control for SGM communities in Uganda and across sub-Saharan Africa. Keywords: sexual and gender minorities; HIV; education; training; sub-Saharan Africa; Uganda; PEPFAR, 1 | INTRODUCTION Sexual and gender minority (SGM) people are often stigmatized and mistreated based on their sexual orientation, gender identity or gender expression. Training healthcare workers on serving SGM [...]

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]

BackgroundIntimate partner violence (IPV) is associated with higher HIV incidence, reduced condom use, and poor adherence to antiretroviral therapy and other medications. IPV may also affect adherence to pre-exposure prophylaxis (PrEP).MethodsWe analyzed data from 1785 HIV-uninfected women enrolled in a clinical trial of PrEP among African HIV serodiscordant couples. Experience of verbal, physical, or economic IPV was assessed at monthly visits by face-to-face interviews. Low PrEP adherence was defined as clinic-based pill count coverage

BackgroundIntimate partner violence (IPV) is associated with higher HIV incidence, reduced condom use, and poor adherence to antiretroviral therapy and other medications. IPV may also affect adherence to pre-exposure prophylaxis (PrEP).MethodsWe analyzed data from 1785 HIV-uninfected women enrolled in a clinical trial of PrEP among African HIV serodiscordant couples. Experience of verbal, physical, or economic IPV was assessed at monthly visits by face-to-face interviews. Low PrEP adherence was defined as clinic-based pill count coverage

BackgroundImmune reconstitution inflammatory syndrome (IRIS) in human immunodeficiency virus (HIV)-infected persons beginning antiretroviral therapy (ART) has been incompletely characterized for herpes simplex virus type 2 (HSV-2).MethodsWe evaluated genital ulcer disease (GUD) and HSV-2-associated GUD at quarterly visits or when spontaneously reported at monthly visits in 3381 HIV/HSV-2-coinfected individuals in a placebo-controlled trial of suppressive acyclovir therapy to prevent HIV transmission, 349 of whom initiated ART during the study. Incidence was calculated for months before and after ART initiation, and incidence rate ratios (IRRs) were calculated.ResultsGUD incidence increased from 15.0 episodes per 100 person-years before ART to 26.9 episodes per 100 person-years in the first full quarter after ART initiation (IRR, 1.83;P= .03), and the incidence of HSV-2-associated GUD increased from 8.1 to 19.0 episodes per 100 person-years (IRR, 2.20;P= .02). Subsequently, the incidence of GUD was similar to that before ART, although the numbers were small. Persons receiving suppressive acyclovir had fewer GUD episodes, but the IRR after beginning ART was similar in the acyclovir and placebo groups.ConclusionsInitiation of ART in HIV/HSV-2-coinfected persons is associated with a transient increase in GUD and HSV-2 GUD. Acyclovir reduces the incidence of GUD but does not prevent an increase in GUD incidence during the first quarter following initiation of ART.

: Introduction: Increased HIV testing by men in sub‐Saharan Africa is key to meeting UNAIDS 2025 testing targets. Secondary distribution of HIV self‐testing (HIVST) kits by pregnant women attending antenatal care to male partners has been shown to increase testing among African men. A detailed understanding of how women and male partners manage the distribution and use of HIVST and subsequent linkage to clinic‐based follow‐up can inform implementation and scale‐up efforts. Methods: We use qualitative data from the Obumu Study, a randomized trial of secondary distribution of HIVST by pregnant women living with HIV to male partners in Kampala, Uganda, to unpack the HIVST delivery process. The protocol included a clinic visit by male partners to confirm HIVST results. Individual interviews eliciting data on experiences of delivering and using HIVST and of subsequent linkage to clinic‐based testing were conducted with a purposefully selected sample of 45 women and 45 male partner Obumu Study participants from November 2018 to March 2021. Interview data from 59 participants (29 women and 30 men) in the HIVST arm were analysed through coding and category construction. Results: Women living with HIV were apprehensive about delivering HIVST to their partners, especially if they had not disclosed their HIV status. They invested effort in developing strategies for introducing HIVST. Male partners described a range of responses to receiving the self‐testing kit, especially fear of a positive test result. Women reported leading the self‐testing process, often conducting the test themselves. Most women confidently interpreted HIVST results. However, they tended to defer to healthcare workers rather than report positive results directly to partners. Women told their partners the testing process required a clinic follow‐up visit, often without explaining the visit's purpose. Many partners delayed the visit as a result. Women again responded by strategizing to persuade their partners to link to follow‐up care. Conclusions: Secondary distribution of HIVST by pregnant women living with HIV to male partners can be challenging, especially when women have not disclosed their HIV status. Additional support may alleviate the burden; outreach to male partners may facilitate linkage to confirmatory testing and HIV care or prevention., INTRODUCTION Increasing rates of HIV testing by men in sub‐Saharan Africa is key to meeting the UNAIDS 2025 target calling for 95% of individuals living with HIV to know their [...]

BackgroundThe efficacy of condoms for protection against transmission of herpes simplex virus type 2 (HSV-2) has been examined in a variety of populations with different effect measures. Often the efficacy has been assessed as change in hazard of transmission with consistent vs inconsistent use, independent of the number of acts. Condom efficacy has not previously measured on a per-act basis.MethodsWe examined the per-act HSV-2 transmission rates with and without condom use among 911 African HSV-2 and human immunodeficiency virus type 1 (HIV-1) serodiscordant couples followed for an average of 18 months in an HIV prevention study. Infectivity models were used to associate the log10 probability of HSV-2 transmission over monthly risk periods with reported numbers of protected and unprotected sex acts. Condom efficacy was computed as the proportionate reduction in transmission risk for protected relative to unprotected sex acts.ResultsTransmission of HSV-2 occurred in 68 couples, including 17 with susceptible women and 51 with susceptible men. The highest rate of transmission was from men to women: 28.5 transmissions per 1000 unprotected sex acts. We found that condoms were differentially protective against HSV-2 transmission by sex; condom use reduced per-act risk of transmission from men to women by 96% (P < .001) and marginally from women to men by 65% (P = .060).ConclusionsCondoms are recommended as an effective preventive method for heterosexual transmission of HSV-2.