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.

Oral PrEP uptake, adherence, and persistence during periconception periods among women in South Africa: an intervention study.

OBJECTIVE: We developed the Healthy Families-PrEP intervention to support HIV-prevention during periconception and pregnancy. We evaluated preexposure prophylaxis (PrEP) use with three objective measures. DESIGN: This single-arm intervention study enrolled women in KwaZulu-Natal, South Africa, who were HIV-uninfected, not pregnant, in a relationship with a partner with HIV or unknown-serostatus, and with pregnancy plans. PrEP was offered as part of a comprehensive HIV prevention intervention. Participants were followed for 12#$##x0200A;months. METHODS: We evaluated periconception PrEP uptake and adherence using quarterly plasma tenofovir concentrations. We modeled factors associated with PrEP uptake and high plasma tenofovir (past day dosing). Patterns of use were analyzed using electronic pillcap data. Dried blood spots to measure intracellular tenofovir product (past 2#$##x0200A;months dosing) were analyzed for a subset of women. RESULTS: Three hundred thirty women with median age 24 (IQR: 22#$#ndash;27) years enrolled. Partner HIV-serostatus was unknown by 96% (N#$##x0200A;#$#equals;#$##x0200A;316); 60% (195) initiated PrEP. High plasma tenofovir concentrations were seen in 35, 25, 22, and 20% of samples at 3, 6, 9, and 12#$##x0200A;months, respectively. Similar adherence was measured by pillcap and dried blood spots. In adjusted models, lower income, alcohol use, and higher HIV stigma were associated with high plasma tenofovir. Eleven HIV-seroconversions were observed (incidence rate: 4.04/100 person-years [95% confidence interval: 2.24#$#ndash;7.30]). None had detectable plasma tenofovir. CONCLUSION: The Healthy Families-PrEP intervention supported women in PrEP use. We observed high interest in periconception PrEP and over one-third adhered to PrEP in the first quarter; one-fifth were adherent over a year. High HIV incidence highlights the importance of strategies to reduce HIV incidence among periconception women. CLINICAL TRIAL NUMBER: NCT03194308.

How PrEP delivery was integrated into public ART clinics in central Uganda: A qualitative analysis of implementation processes.

Tailored delivery strategies are important for optimizing the benefit and overall reach of PrEP in sub-Saharan Africa. An integrated approach of delivering time-limited PrEP in combination with ART to serodifferent couples encourages PrEP use in the HIV-negative partner as a bridge to sustained ART use. Although PrEP has been delivered in ART clinics for many years, the processes involved in integrating PrEP into ART services are not well understood. The Partners PrEP Program was a stepped-wedge cluster randomized trial of integrated PrEP and ART delivery for HIV serodifferent couples in 12 public health facilities in central Uganda (Clinicaltrials.gov NCT03586128). Using qualitative data, we identified and characterized key implementation processes that explain how PrEP delivery was integrated into existing ART services in the Partners PrEP Program. In-depth interviews were conducted with a purposefully-selected sub-sample of 83 members of 42 participating serodifferent couples, and with 36 health care providers implementing integrated delivery. High quality training, technical supervision, and teamwork were identified as key processes supporting providers to implement PrEP delivery. Interest in the PrEP program was promoted through the numerous ways health care providers made integrated ART and PrEP meaningful for serodifferent couples, including tailored counseling messages, efforts to build confidence in integrated delivery, and strategies to create demand for PrEP. Couples in the qualitative sample responded positively to providers' efforts to promote the integrated strategy. HIV-negative partners initiated PrEP to preserve their relationships, which inspired their partners living with HIV to recommit to ART adherence. Lack of disclosure among couples and poor retention on PrEP were identified as barriers to implementation of the PrEP program. A greater emphasis on understanding the meaning of PrEP for users and its contribution to implementation promises to strengthen future research on PrEP scale up in sub-Saharan Africa.

Behavioral Modeling and its Association with PrEP and ART Use in Ugandan HIV-Serodifferent Couples.

Integrating Pre-Exposure Prophylaxis (PrEP) delivery into Antiretroviral Therapy (ART) programs bridges the Human Immunodeficiency Virus (HIV) prevention gap for HIV-serodifferent couples prior to the partner living with HIV achieving viral suppression. Behavioral modeling is one mechanism that could explain health-related behavior among couples, including those using antiretroviral medications, but few tools exist to measure the extent to which behavior is modeled. Using a longitudinal observational design nested within a cluster randomized trial, this study examined the factor structure and assessed the internal consistency of a novel 24-item, four-point Likert-type scale to measure behavioral modeling and the association of behavioral modeling with medication-taking behaviors among heterosexual, cis-gender HIV-serodifferent couples. In 149 couples enrolled for research, a five-factor model provided the best statistical and conceptual fit, including attention to partner behavior, collective action, role modeling, motivation, and relationship quality. Behavioral modeling was associated with medication-taking behaviors among members of serodifferent couples. Partner modeling of ART/PrEP taking could be an important target for assessment and intervention in HIV prevention programs for HIV serodifferent couples.

Intimate Partner Violence and Adherence to PrEP and ART Among Ugandan HIV Serodifferent Couples.

BACKGROUND: Intimate 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. METHODS: We 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. RESULTS: We 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: 4.78, 95% confidence interval: 1.48 to 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 with those with low relationship powerlessness (20% vs. 30%, odds ratio: 0.57, 95% confidence interval: 0.36 to 0.90). We observed no association between relationship powerlessness and ART adherence. CONCLUSIONS: We 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.

"Gender-based Violence (GBV) and HIV, they are like sister and brother": barriers and facilitators to GBV screening and referral in public HIV treatment settings in Uganda.

BACKGROUND: People living with HIV are vulnerable to gender-based violence (GBV), which can negatively impact HIV treatment outcomes. National guidelines in Uganda recommend GBV screening alongside HIV treatment services. We explored barriers and facilitators to providers implementing GBV screening and referral in public antiretroviral therapy (ART) clinics in Uganda. METHODS: We conducted qualitative in-depth interviews. Providers were purposively sampled from 12 ART clinics to represent variation in clinical specialty and gender. We used the Theoretical Domains Framework to structure our deductive analysis. RESULTS: We conducted 30 in-depth interviews with providers implementing GBV screening and/or referral. Respondents had a median age of 36 (IQR: 30, 43) years and had been offering post-GBV care to clients for a median duration of 5 (4, 7) years. 67% of respondents identified as female and 57% were counselors. Facilitators of GBV screening and referral included providers having access to post-GBV standard operating procedures and screening tools, trainings offered by the Ministry of Health, facility-sponsored continuing medical education units and support from colleagues. Respondents indicated that referrals were uncommon, citing the following barriers: negative expectations regarding the quality and quantity of referral services; lack of financial resources to support clients, facilities, and referral partners throughout the referral process; and sociocultural factors that threatened client willingness to pursue post-GBV support services. CONCLUSIONS: Findings from this evaluation support the refinement of GBV screening and referral implementation strategies that leverage facilitators and address barriers to better support individuals living with HIV and who may have heightened vulnerability to GBV.

"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.

Healthcare worker perceived barriers and facilitators to implementing a tuberculosis preventive therapy program in rural South Africa: a content analysis using the consolidated framework for implementation research.

BACKGROUND: South African national tuberculosis (TB) guidelines, in accordance with the World Health Organization, recommend conducting routine household TB contact investigation with provision of TB preventive therapy (TPT) for those who qualify. However, implementation of TPT has been suboptimal in rural South Africa. We sought to identify barriers and facilitators to TB contact investigations and TPT management in rural Eastern Cape, South Africa, to inform the development of an implementation strategy to launch a comprehensive TB program. METHODS: We collected qualitative data through individual semi-structured interviews with 19 healthcare workers at a district hospital and four surrounding primary-care clinics referring to the hospital. The consolidated framework for implementation research (CFIR) was used to develop interview questions as well as guide deductive content analysis to determine potential drivers of implementation success or failure. RESULTS: A total of 19 healthcare workers were interviewed. Identified common barriers included lack of provider knowledge regarding efficacy of TPT, lack of TPT documentation workflows for clinicians, and widespread community resource constraints. Facilitators identified included healthcare workers high interest to learn more about the effectiveness of TPT, interest in problem-solving logistical barriers in provision of comprehensive TB care (including TPT), and desire for clinic and nurse-led TB prevention efforts. CONCLUSION: The use of the CFIR, a validated implementation determinants framework, provided a systematic approach to identify barriers and facilitators to TB household contact investigation, specifically the provision and management of TPT in this rural, high TB burden setting. Specific resources-time, trainings, and evidence-are necessary to ensure healthcare providers feel knowledgeable and competent about TPT prior to prescribing it more broadly. Tangible resources such as improved data systems coupled with political coordination and funding for TPT programming are essential for sustainability.

Healthcare worker knowledge, attitudes, and beliefs regarding tuberculosis preventive therapy in rural South Africa: A content analysis using the consolidated framework for implementation research.

BACKGROUND: South African national tuberculosis (TB) guidelines, in accordance with the World Health Organization, recommend conducting routine household TB contact investigation with provision of TB preventive therapy (TPT) for those who qualify. However, implementation of TPT has been suboptimal in rural South Africa. We sought to identify barriers and facilitators to TB contact investigations and TPT management in rural Eastern Cape, South Africa to inform the development of an implementation strategy to launch a comprehensive TB program. METHODS: We collected qualitative data through individual semi-structured interviews with 19 healthcare workers at a district hospital and four surrounding primary-care clinics referring to the hospital. The consolidated framework for implementation research (CFIR) was used to develop interview questions as well as guide deductive content analysis to determine potential drivers of implementation success or failure. RESULTS: A total of 19 healthcare workers were interviewed. Identified common barriers included lack of provider knowledge regarding efficacy of TPT, lack of TPT documentation workflows for clinicians, and widespread community resource constraints. Facilitators identified included healthcare workers high interest to learn more about the effectiveness of TPT, interest in problem-solving logistical barriers in provision of comprehensive TB care (including TPT), and desire for clinic and nurse-led TB prevention efforts. CONCLUSION: The use of the CFIR, a validated implementation determinants framework, provided a systematic approach to identify barriers and facilitators to TB household contact investigation, specifically the provision and management of TPT in this rural, high TB burden setting. Specific resources - time, trainings, and evidence - are necessary to ensure healthcare providers feel knowledgeable and competent about TPT prior to prescribing it more broadly. Tangible resources such as improved data systems coupled with political coordination and funding for TPT programming are essential for sustainability.

How Central Ugandan HIV Clinics Adapted During COVID-19 Lockdown Restrictions to Promote Continuous Access to Care: A Qualitative Analysis.

We used qualitative data from the Partners PrEP Program (PPP) to address the question: How did Central Ugandan HIV clinics adapt to COVID-19 lockdown restrictions to promote continuous access to HIV care? PPP was a stepped-wedge cluster randomized trial of integrated PrEP and ART delivery for HIV serodifferent couples at Central Ugandan HIV clinics (NCT03586128). Individual interviews with purposefully selected PPP couples (N = 42) and clinicians, coordinators, and counselors providing HIV care (N = 36) were carried out. Sixty-four interviews were completed after lockdown and included questions about accessing and providing ART/PrEP refills during lockdown restrictions. We used an inductive, content-focused approach to analyze these interview data. Barriers to continuous access identified by interviewees included loss of income with increased cost of transport, reduced staff at clinics, and physical distancing at clinics. Interviewees pointed to multi-month refills, visits to clinics "close to home," transport to clinics for providers, and delivery of refills in neighborhoods as factors promoting continuous access to antiretroviral medications. Access barriers appeared somewhat different for ART and PrEP. Fewer resources for community delivery and pre-refill HIV testing requirements were identified as PrEP-specific access challenges. Participants emphasized their success in continuing ART/PrEP adherence during the lockdown, while providers emphasized missed refill visits. These results highlight the contributions of providers and ART/PrEP users to adaptation of HIV services during COVID-19 lockdown restrictions in Uganda. The roles of direct care providers and service users as drivers of adaptation should be recognized in future efforts to conceptualize and investigate health system resiliency.

Evaluating the Feasibility, Acceptability, and Preliminary Efficacy of SupportMoms-Uganda, an mHealth-Based Patient-Centered Social Support Intervention to Improve the Use of Maternity Services Among Pregnant Women in Rural Southwestern Uganda: Randomized Controlled Trial.

BACKGROUND: SMS text messaging and other mobile health (mHealth) interventions may improve knowledge transfer, strengthen access to social support (SS), and promote positive health behaviors among women in the perinatal period. However, few mHealth apps have been taken to scale in sub-Saharan Africa. OBJECTIVE: We evaluated the feasibility, acceptability, and preliminary efficacy of a novel, mHealth-based, and patient-centered messaging app designed using behavioral science frameworks to promote maternity service use among pregnant women in Uganda. METHODS: We performed a pilot randomized controlled trial between August 2020 and May 2021 at a referral hospital in Southwestern Uganda. We included 120 adult pregnant women enrolled in a 1:1:1 ratio to receive routine antenatal care (ANC; control), scheduled SMS text or audio messages from a novel messaging prototype (scheduled messaging [SM]), and SM plus SMS text messaging reminders to 2 participant-identified social supporters (SS). Participants completed face-to-face surveys at enrollment and in the postpartum period. The primary outcomes were feasibility and acceptability of the messaging prototype. Other outcomes included ANC attendance, skilled delivery, and SS. We conducted qualitative exit interviews with 15 women from each intervention arm to explore the intervention mechanisms. Quantitative and qualitative data were analyzed using STATA and NVivo, respectively. RESULTS: More than 85% and 75% of participants received ≥85% of the intended SMS text messages or voice calls, respectively. More than 85% of the intended messages were received within 1 hour of the expected time; 18% (7/40) of women experienced network issues for both intervention groups. Over 90% (36/40) of the intervention participants found this app useful, easy to use, engaging, and compatible and strongly recommended it to others; 70% (28/40), 78% (31/40), and 98% (39/40; P=.04) of women in the control, SM, and SS arms, respectively, had a skilled delivery. Half (20/40), 83% (33/40), and all (40/40; P=.001) of the women in the control, SM, and SS arms attended ≥4 ANC visits, respectively. Women in the SS arm reported the highest support (median 3.4, IQR 2.8-3.6; P=.02); <20% (8/40; P=.002) missed any scheduled ANC visit owing to lack of transportation. Qualitative data showed that women liked the app; they were able to comprehend ANC and skilled delivery benefits and easily share and discuss tailored information with their significant others, who in turn committed to providing them the needed support to prepare and seek help. CONCLUSIONS: We demonstrated that developing a novel patient-centered and tailored messaging app that leverages SS networks and relationships is a feasible, acceptable, and useful approach to communicate important targeted health-related information and support pregnant women in rural Southwestern Uganda to use available maternity care services. Further evaluation of maternal-fetal outcomes and integration of this intervention into routine care is needed. TRIAL REGISTRATION: ClinicalTrials.gov NCT04313348; https://clinicaltrials.gov/ct2/show/NCT04313348.

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.

Influences on PrEP Uptake and Adherence Among South African Women During Periconception and Pregnancy: A Qualitative Analysis.

Pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, yet PrEP delivery to women in periconception and pregnancy has lagged. We report qualitative research from a study evaluating PrEP use as part of safer conception care for 330 South African women. Fifty-two semi-structured interviews were conducted with 25 study participants to identify influences on PrEP adherence. Influences were: (1) changing proximity to male partners; (2) COVID-19 lockdown; (3) mobile lifestyle; (4) PrEP-related stigma; (5) disclosure of PrEP use; and (6) pregnancy and motherhood. Data also revealed important contextual information shaping adherence influences for women, including: (a) not living with partners, (b) partners as drivers of pregnancy intention, and (c) feeling at high risk for HIV. Disclosure of PrEP use, addressing stigma, strategies for traveling with pills, and counseling on prevention effective adherence are promising components of PrEP-inclusive HIV prevention interventions for South African women who are pregnant or planning pregnancy.

"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.

PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial.

Background: Global scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including uptake and adherence to PrEP and antiretroviral treatment (ART), to describe the impact of integrating PrEP into an existing HIV program. Methods: Using a stepped-wedge cluster randomized trial design, we launched PrEP delivery for HIV-negative members of serodifferent couples in Uganda by integrating PrEP into existing ART programs for people living with HIV. The program provided PrEP training for ART providers, ongoing technical assistance, and a provisional supply chain mechanism for PrEP medication. Primary data on PrEP initiation, PrEP refills, ART initiation, and HIV viremia at 6 months (measured at 42-270 days) were collected through data abstraction of medical records from HIV-serodifferent couples sequentially enrolling at the ART clinics. Modified Poisson regression models, controlling for time and cluster, compared viral suppression (<1000 copies/ml) before and after launch of the PrEP program. This trial was registered at ClinicalTrials.gov, NCT03586128. Findings: From June 1, 2018-December 15, 2020, 1,381 HIV-serodifferent couples were enrolled across 12 ART clinics in Kampala and Wakiso, Uganda, including 730 enrolled before and 651 after the launch of PrEP delivery. During the baseline period, 99.4% of partners living with HIV initiated ART and 85.0% were virally suppressed at 6 months. Among HIV-negative partners enrolled after PrEP launched, 81.0% (527/651) initiated PrEP within 90 days of enrolling; among these 527, 11.2% sought a refill 6 months later. In our powered intent-to-treat analysis, 82.1% and 76.7% of partners living with HIV were virally suppressed, respectively, which was not a statistically significant difference (RR=0.94, 95% CI: 0.82-1.07) and was stable across sensitivity analyses. Interpretation: Integration of PrEP into ART clinics reached a high proportion of people in HIV-serodifferent relationships and did not improve the already high frequency of HIV viral suppression among partners living with HIV. Funding: National Institute of Mental Health (R01MH110296).

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.

Understanding PrEP Acceptability Among Priority Populations: Results from a Qualitative Study of Potential Users in Central Uganda.

Daily oral pre-exposure prophylaxis (PrEP) can safely and effectively prevent HIV acquisition in HIV-negative individuals. However, uptake of PrEP has been suboptimal in sub-Saharan Africa. The goal of this qualitative study was to identify facilitators of and barriers to PrEP acceptability among target users not taking PrEP. Fifty-nine individuals belonging to Ugandan priority populations participated in a single in-depth interview. Participants perceived themselves as being at high risk for HIV acquisition, and expressed interest in PrEP as an HIV prevention strategy. Two forms of stigma emerged as potential barriers to PrEP use: (1) misidentification as living with HIV; and (2) disclosure of membership in a priority population. Acceptability of PrEP was dampened for this sample of potential PrEP users due to anticipated stigmatization. Mitigating stigma should be a key component of effective PrEP delivery to reach UNAIDS goal of ending the AIDS epidemic by 2030.

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.