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.

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.

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.