Urine tenofovir testing for real-time PrEP adherence feedback: a qualitative study involving transgender women in Uganda.

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.

"I felt special!": a qualitative study of peer-delivered HIV self-tests, STI self-sampling kits and PrEP for transgender women in Uganda.

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.

Partner testing with HIV self-test distribution by Ugandan pregnant women living with HIV: a randomized trial.

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.

Depression and PrEP uptake, interruption, and adherence among young women in Uganda.

Depression is a common cause of morbidity globally and can impact adherence to medications, posing challenges to medication-based HIV prevention. The objectives of this work are to describe the frequency of depression symptoms in a cohort of 499 young women in Kampala, Uganda and to determine the association of depression symptoms with use of HIV pre-exposure prophylaxis (PrEP). Mild or greater depression, assessed by the patient health questionnaire (PHQ-9), was experienced by 34% of participants at enrollment. Participants with mild depression symptoms tended to uptake PrEP, request PrEP refills, and adhere to PrEP with similar frequency to women with no/minimal signs of depression. These findings highlight opportunities to leverage existing HIV prevention programs to identify women who may benefit from mental health services and may not otherwise be screened.Trial registration: ClinicalTrials.gov identifier: NCT03464266..

Pregnant women and male partner perspectives of secondary distribution of HIV self-testing kits in Uganda: A qualitative study.

BACKGROUND: HIV self-testing (HIVST) is a promising strategy to increase awareness of HIV status among sub-Saharan African (SSA) men. Understanding user perspectives on HIVST secondary distribution from pregnant women attending antenatal care (ANC) to their male partners is crucial to optimizing delivery strategies. METHODS: We sampled pregnant women attending ANC without their partners and purposively oversampled pregnant women living with HIV (PWHIV) to understand their unique views. We recruited male partners after obtaining contact information from women. We conducted 14 focus group discussions and 10 in-depth interviews with men and pregnant women. We assessed acceptability of HIVST secondary distribution, barriers, facilitators, and interventions to increase HIVST uptake. RESULTS: Participants felt that HIVST secondary distribution was acceptable, particularly for women in stable relationships. However, many expressed concerns about accusations of mistrust, relationship dissolution, fear of discovering serodifference, and lack of counseling associated with HIVST. PWHIV reported hesitation about secondary distribution, citing fears of unintended HIV status disclosure and abandonment resulting in financial hardship for themselves and their infant. Some participants preferred that providers contact men directly to offer HIVST kits instead of distribution via women. Participants reported that community sensitization, availability of phone-based counseling, male clinic staff, extended clinic hours, and financial incentives could increase men's HIVST use and linkage to care. CONCLUSION: Participants expressed high interest in using HIVST, but secondary distribution was not universally preferred. We identified potential strategies to increase HIVST acceptability, particularly among PWHIV and those in unstable partnerships which can inform strategies to optimize HIVST distribution.

How pregnant women living with HIV and their male partners manage men's HIV self-testing: qualitative analysis of an HIVST secondary distribution process in Kampala, Uganda.

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.

"Him Leaving Me - That is My Fear Now": A Mixed Methods Analysis of Relationship Dissolution Between Ugandan Pregnant and Postpartum Women Living with HIV and Their Male Partners.

High rates of relationship dissolution among pregnant women living with HIV (PWLHIV) and their male partners might increase mothers' and children's vulnerability to financial hardship and poor health outcomes. This mixed methods analysis identified factors associated with separation between PWLHIV and their male partners. We utilized data from a randomized controlled trial ( www.ClinicalTrials.gov NCT03484533) of 500 PWLHIV attending antenatal care in Uganda and 237 male partners between 2018 and 2020 and followed until 12 months postpartum. Multivariate regression models estimated the impact of relationship factors on the adjusted relative risk of separation during follow up, and we conducted in-depth interviews with 45 women and 45 men enrolled in the trial. Overall, 23% of PWLHIV reported separation during the study period. HIV serodifferent status, financial burdens and gender expectations were sources of relationship conflict. Significant factors associated with separation included unmarried, non-cohabitating, shorter, polygamous relationships, as well as HIV non-disclosure and verbal abuse. Participants discussed potential positive and negative consequences of separation, including impact on their mental health, treatment continuation, financial security, and safety. Addressing relationship dynamics is essential to improve counseling messaging and support PWLHIV who are experiencing relationship conflict.

"It Soothes Your Heart": A Multimethod Study Exploring Acceptability of Point-of-Care Viral Load Testing among Ugandan Pregnant and Postpartum Women Living with HIV.

BACKGROUND: High adherence to antiretroviral therapy (ART) is critical for achieving viral suppression and preventing onward HIV transmission. ART continuation can be challenging for pregnant women living with HIV (PWLHIV), which has critical implications for risk of vertical HIV transmission. Point-of-care viral load (POC VL) testing has been associated with improved treatment and retention outcomes. We sought to explore acceptability of POC VL testing among Ugandan PWLHIV during pregnancy and postpartum. METHODS: This multimethod analysis drew on quantitative and qualitative data collected between February and December 2021. Quantitatively, we used an intent-to-treat analysis to assess whether randomization to clinic-based POC VL testing during pregnancy and infant testing at delivery was associated with improved viral suppression (≤50 copies/mL) by 3 months postpartum compared to standard-of-care (SOC) VL testing through a central laboratory, adjusting for factorial randomization for the male partner testing strategy. Additionally, a subset of 22 PWLHIV in the POC VL arm participated in in-depth qualitative interviews. We inductively analyzed transcripts to develop categories representing concepts that characterized women's perceptions of POC VL testing during pregnancy and at delivery and ways that POC VL testing may have impacted their ART adherence and viral suppression. Key themes around women's perceptions of POC VL testing were then organized into main categories. RESULTS: Overall, 151 PWLHIV were enrolled into the study, 77 (51%) of whom were randomized to receive POC VL testing during pregnancy and at delivery. Women reported in qualitative interviews that POC VL testing had (1) motivated their ART adherence during pregnancy and postpartum and that they felt this testing method had (2) helped them protect their infants from acquiring HIV and (3) improved their emotional wellbeing. CONCLUSIONS: POC VL testing was highly acceptable among Ugandan PWLHIV and was viewed as an important tool that women believed improved their ART adherence, gave them information necessary to protect their infants from vertical HIV acquisition, and improved their emotional wellbeing. These findings support the global scale-up of POC VL testing in settings with high HIV burden, especially for PWLHIV who may be at risk of treatment disruptions or loss to follow-up.

Health Care Worker Perspectives of HIV Pre-exposure Prophylaxis Service Delivery in Central Uganda.

Background: Scale-up of HIV pre-exposure prophylaxis (PrEP) services in Uganda is ongoing. However, health care workers (HCWs) may not be aware of PrEP nor what offering this service entails. We explored the impact of standardized HCW training on the knowledge and perspectives of PrEP service delivery in Uganda. Methods: We recruited HCWs from facilities that offered HIV-related services in Central Uganda. Using the Uganda Ministry of Health curriculum, we trained HCWs on PrEP services. We collected data about PrEP knowledge, preparedness, and willingness to deliver PrEP to multiple key populations before the training, immediately after the training, and >6 months later (exit). We additionally conducted 15 qualitative interviews after the exit survey. Quantitative data were analyzed by Fisher exact test, while qualitative interview data were analyzed inductively. Results: We recruited 80 HCWs from 35 facilities in urban (N = 24, 30%), peri-urban (N = 30, 37%), and rural (N = 26, 33%) areas. Most HCWs were nurse counselors (N = 52, 65%) or medical/clinical officers (N = 15, 18%). Surveys indicated that awareness of PrEP increased after the training and remained high. Knowledge of PrEP (i.e., as an effective, short-term antiretroviral medication to use before HIV exposure for people at high risk) generally increased with training, but significant gaps remained, and knowledge decreased with time. Most HCWs recommended PrEP for female sex workers and HIV serodifferent couples, as well as other key populations. We observed increases in the number of HCW who felt their facility was prepared to cater for HIV prevention and provide PrEP, but this view was not universal. HCWs believed in PrEP effectiveness and embraced it as an additional HIV prevention method. Concerns included patient adherence and behavioral risk compensation. HCWs noted challenges in PrEP delivery in terms of inadequate clinic preparedness, infrastructure, staff capacity, and poor attitudes toward key populations by untrained health workers. They felt further training was needed to ensure a smooth scale-up of services without stigmatization. Conclusions: Standardized training improved knowledge, willingness, and preparedness to offer PrEP services among most HCWs in Central Uganda. Ongoing training will be needed to optimize PrEP delivery services and expand delivery to levels needed for population-level impact.

Effect of HIV Self-Testing on PrEP Adherence Among Gender-Diverse Sex Workers in Uganda: A Randomized Trial.

BACKGROUND: HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP) are complementary tools that could empower sex workers to control their HIV protection, but few studies have jointly evaluated PrEP and HIVST in any setting. METHODS: The Empower Study was an open-label randomized trial in Uganda. Sex workers were offered F/tenofovir disoproxil fumarate and randomized 1:1 to monthly HIVST and quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing alone (standard of care) and followed up for 12 months. PrEP adherence was measured using electronic adherence monitoring and tenofovir diphosphate (TFV-DP) levels in dried blood spots. Adherence outcomes and sexual behaviors were compared by arm using generalized estimating equation models. RESULTS: We enrolled 110 sex workers: 84 cisgender women, 14 transgender women, 10 men who have sex with men, and 2 transgender men. The median age was 23 years. The 12-month retention was 75%. Nearly all (99.4%) used ≥1 HIVST kit. The proportion with TFV-DP levels ≥700 fmol/punch in the HIVST and standard of care arms at the 3-, 6-, 9-, and 12-month visits was 2.4%, 2.3%, 0%, and 0% and 7.9%, 0%, 0%, and 0%, respectively, with no differences by randomization arm (P > 0.2). Self-reported condomless sex acts with paying partners was similar by arm [adjusted incidence rate ratio 0.70; 95% confidence interval (CI): 0.42 to 1.17; P = 0.18]. One seroconversion occurred (HIV incidence, 0.9/100 person-years); TFV-DP was not detected at any visit. CONCLUSIONS: A gender-diverse sample of sex workers in Uganda used HIVST but not daily oral PrEP for HIV protection. Alternate approaches to promote PrEP use, including long-acting formulations, should be considered in this population.

"You are not a man": a multi-method study of trans stigma and risk of HIV and sexually transmitted infections among trans men in Uganda.

INTRODUCTION: Transgender (trans) men in sub-Saharan Africa are a hidden and vulnerable population who may engage in sex work due to socio-economic exclusion and lack of alternative employment opportunities. Little is known about HIV and sexually transmitted infection (STI) risk among trans men in this setting. We conducted a multi-method study to characterize HIV/STI risk among trans men in Uganda. METHODS: Between January and October 2020, we enrolled 50 trans men into a cross-sectional study through snowball sampling. Data were collected on socio-demographic characteristics, sexual practices and depression. We conducted 20 qualitative interviews to explore: (1) descriptions of sexual practices that could increase HIV/STI exposure; (2) experiences of accessing public healthcare facilities; (3) perceptions of HIV or STI testing; (4) HIV and STI service delivery; and (5) drug and alcohol use. We used an inductive content analytic approach centring on descriptive category development to analyse the data. RESULTS: The median age was 25 years (interquartile range 23-28). The prevalence of HIV, syphilis and hepatitis B was 4%, 6% and 8%, respectively. We observed multiple levels of intersecting individual, interpersonal and structural stigmas. (1) Trans men reported transphobic rape motivated by interpersonal stigma that was psychologically traumatizing to the survivor. The resultant stigma and shame hindered healthcare access. (2) Structural stigma and economic vulnerability led to sex work, which increased the risk of HIV and other STIs. Sex work stigma further compounded vulnerability. (3) Individualized stigma led to fear of disclosure of gender identity and HIV status. Concealment was used as a form of stigma management. (4) Multiple levels of stigma hampered access to healthcare services. Preference for trans-friendly care was motivated by stigma avoidance in public facilities. Overall, the lived experiences of trans men highlight the intertwined relationship between stigma and sexual health. CONCLUSIONS: In this sample from Uganda, trans men experienced stigma at multiple levels, highlighting the need for gender-sensitive healthcare delivery. Stigma reduction interventions, including provider training, non-discrimination policies, support groups and stigma counselling, could strengthen uptake and utilization of prevention services by this marginalized population.

HIV self-testing and oral pre-exposure prophylaxis are empowering for sex workers and their intimate partners: a qualitative study in Uganda.

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 trial of HIVST and PrEP among 110 HIV-negative cisgender women, cisgender men and transgender 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 sexual partners; (c) impact of HIVST on PrEP pill taking; and (d) sexual risk 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 sexual behaviours. Data were analysed using an inductive content analytic approach centering on descriptive category development. Together, these categories detail the 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) sexual health. (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 sexual health. 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.

Correlates of HIV Status Nondisclosure by Pregnant Women Living With HIV to Their Male Partners in Uganda: A Cross-Sectional Study.

BACKGROUND: HIV status disclosure by pregnant women living with HIV (PWLHIV) to their male partners is associated with improved maternal and infant outcomes. Understanding relationship factors associated with nondisclosure of HIV status by PWLHIV to their partners can inform the design of interventions to facilitate disclosure. METHODS: We conducted a cross-sectional study using enrollment data from 500 PWLHIV unaware of their male partners' HIV status and participating in a randomized clinical trial assessing secondary distribution of HIV self-testing kits in Kampala, Uganda. The primary outcome was women's HIV status nondisclosure to their partners. We conducted univariate and multivariate binomial regressions to assess the association between baseline sociodemographic, HIV history, and relationship characteristics with HIV status nondisclosure. RESULTS: 68.2% of the 500 PWLHIV had not disclosed their HIV status to their partner(s). Factors associated with higher likelihood of nondisclosure included relationship duration <1 year [adjusted prevalence ratio (aPR = 1.25); 95% confidence interval (CI): 1.02 to 1.54], being in a polygamous relationship (aPR = 1.21; 95% CI: 1.07 to 1.36), unmarried (aPR = 1.20; 95% CI: 1.07 to 1.35), uncertainty about whether their partner had ever tested for HIV (aPR = 1.55; 95% CI: 1.28 to 1.88), and a lack of social support from people aware of their status (aPR = 1.32; 95% CI: 1.18 to 1.49). CONCLUSION: Relationship factors, including shorter-term, unmarried, and polygamous relationships and uncertainty about partner's HIV testing history, were associated with higher likelihood of pregnant women's nondisclosure of HIV status to their partner. Interventions that facilitate couples' HIV testing and disclosure, provide counseling to reduce relationship dissolution in serodiscordant couples, and offer peer support for women may increase disclosure. CLINICALTRIALSREGISTRATION: Clinicaltrials.gov ID number: NCT03484533.

Knowledge and barriers of PrEP delivery among diverse groups of potential PrEP users in Central Uganda.

BACKGROUND: Scale-up of oral pre-exposure prophylaxis (PrEP) for HIV prevention in Uganda began with serodiscordant couples (SDC) and has expanded to other most at-risk populations (MARPs). We explored knowledge, acceptability, barriers and facilitators of PrEP use among potential PrEP users in four MARPs (SDC; men who have sex with men [MSM]; female sex workers [FSW], and fisher folk). METHODS: We administered quantitative surveys to potential PrEP users in multiple settings in Central Uganda at baseline and approximately 9 months after healthcare worker (HCW) training on PrEP. RESULTS: The survey was completed by 250 potential PrEP users at baseline and 125 after HCW training; 55 completed both surveys. For these 250 participants, mean age was 28.5 years (SD 6.9), 47% were male and 6% were transgender women, with approximately even distribution across MARPs and recruitment locations (urban, peri-urban, and rural). Most (65%) had not heard about PrEP. After HCW training, 24% of those sampled were aware of PrEP, and the proportion of those who accurately described PrEP as "antiretrovirals to be used before HIV exposure" increased from 54% in the baseline survey to 74% in the second survey (p<0.001). The proportion of participants who reported HCW as a source of PrEP information increased after training (59% vs 91%, p<0.001). In both surveys, nearly all participants indicated they were willing to take PrEP if offered. The most common anticipated barriers to PrEP were stigma, transportation, accessibility, busy schedules, and forgetfulness. Closeness to home was a common facilitator for all participant categories. CONCLUSIONS: Initial awareness of PrEP was low, but PrEP knowledge and interest increased among diverse MARPs after HCW training. Demand creation and HCW training will be critical for increasing PrEP awareness among key populations, with support to overcome barriers to PrEP use. These findings should encourage the acceleration of PrEP rollout in Uganda.

Costs of Providing HIV Self-Test Kits to Pregnant Women Living with HIV for Secondary Distribution to Male Partners in Uganda.

BACKGROUND: Secondary distribution of HIV self-testing kits (HIVST) to pregnant women attending antenatal care (ANC) clinics to give to their male partners is a promising strategy to increase testing coverage among men, but its costs are unknown. METHODS: We conducted micro-costing of a trial evaluating secondary distribution of HIVST on pregnant women living with HIV (PWLHIV) in an ANC in Kampala, Uganda. Costs (2019 USD) were collected from program budgets, expenditure records, time and motion observations, and staff interviews and estimated for three scenarios: as-studied, reflecting full costs of the research intervention, Ministry of Health (MOH) implementation, reflecting the research intervention if implemented by the MOH, and MOH roll-out, the current strategy being used to roll out HIVST distribution. RESULTS: In the as-studied scenario, cost of HIVST provision was $13.96/PWLHIV reached, and $11.89 and $10.55 per HIV-positive and HIV-negative male partner, respectively, who linked to a clinic for facility-based testing. In the MOH implementation scenario, costs were $9.45/PWLHIV, and $7.87 and $6.99, respectively, per HIV-positive and HIV-negative male partner linking to the clinic. In the MOH roll-out scenario, the cost of HIVST provision to pregnant women regardless of HIV status was $3.70/woman, and $6.65/HIV-positive male partner. CONCLUSION: Secondary distribution of HIVST from pregnant women can be implemented at reasonable cost to increase testing among men in Uganda and similar settings in Africa.

Counseling Framework for HIV-Serodiscordant Couples on the Integrated Use of Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention.

BACKGROUND: For HIV-serodiscordant couples, integrated delivery of antiretroviral therapy (ART) for HIV-positive partners and time-limited pre-exposure prophylaxis (PrEP) for negative partners virtually eliminates HIV transmission. Standardized messaging, sensitive to the barriers and motivators to HIV treatment and prevention, is needed for widespread scale-up of this approach. METHODS: Within the Partners Demonstration Project, a prospective interventional project among 1013 serodiscordant couples in Kenya and Uganda, we offered ART to eligible HIV-positive partners and PrEP to HIV-negative partners before ART initiation and through the HIV-positive partner's first 6 months of ART use. We conducted individual and group discussions with counseling staff to elicit the health communication framework and key messages about ART and PrEP that were delivered to couples. RESULTS: Counseling sessions for serodiscordant couples about PrEP and ART included discussions of HIV serodiscordance, PrEP and ART initiation and integrated use, and PrEP discontinuation. ART messages emphasized daily, lifelong use for treatment and prevention, adherence, viral suppression, resistance, side effects, and safety of ART during pregnancy. PrEP messages emphasized daily dosing, time-limited PrEP use until the HIV-positive partner sustained 6 months of high adherence to ART, adherence, safety during conception, side effects, and other risks for HIV. CONCLUSIONS: Counseling messages for HIV-serodiscordant couples are integral to the delivery of time-limited PrEP as a "bridge" to ART-driven viral suppression. Their incorporation into programmatic scale-up will maximize intervention impact on the global epidemic.