The Effect of HIV Self-Testing Delivery Models on Female Sex Workers' Sexual Behaviors: A Randomized Controlled Trial in Urban Uganda.

HIV self-testing increases recent and frequent HIV testing among female sex workers (FSWs) in urban Uganda. Using results from a randomized controlled trial, we aim to establish the effect of HIV self-testing delivery models on FSWs' sexual behaviors in this setting. Clusters of one peer educator and eight participants were 1:1:1 randomized to: (1) direct provision of an HIV self-test, (2) provision of a coupon for facility collection of an HIV self-test, or (3) referral to standard-of-care HIV testing services. Sexual behaviors were self-reported at 1 and 4 months. From October to November 2016, 960 participants were enrolled and randomized. At 4 months, there were no statistically significant differences in participants' sexual behaviors, including inconsistent condom use, across study arms. We do not find any changes in sexual risk-taking among FSWs in response to the delivery of HIV self-tests. Routine policies for HIV self-testing are likely a behaviorally safe component of comprehensive HIV prevention strategies.

Acceptability of HIV self-testing to support pre-exposure prophylaxis among female sex workers in Uganda and Zambia: results from two randomized controlled trials.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is highly effective for prevention of HIV acquisition, but requires HIV testing at regular intervals. Female sex workers (FSWs) are a priority population for HIV prevention interventions in many settings, but face barriers to accessing healthcare. Here, we assessed the acceptability of HIV self-testing for regular HIV testing during PrEP implementation among FSWs participating in a randomized controlled trial of HIV self-testing delivery models. METHODS: We used data from two HIV self-testing randomized controlled trials with identical protocols in Zambia and in Uganda. From September-October 2016, participants were randomized in groups to: (1) direct delivery of an HIV self-test, (2) delivery of a coupon, exchangeable for an HIV self-test at nearby health clinics, or (3) standard HIV testing services. Participants completed assessments at baseline and 4 weeks. Participants reporting their last HIV test was negative were asked about their interest in various PrEP modalities and their HIV testing preferences. We used mixed effects logistic regression models to measure differences in outcomes across randomization arms at four weeks. RESULTS: At 4 weeks, 633 participants in Zambia and 749 participants in Uganda reported testing negative at their last HIV test. The majority of participants in both studies were "very interested" in daily oral PrEP (91% Zambia; 66% Uganda) and preferred HIV self-testing to standard testing services while on PrEP (87% Zambia; 82% Uganda). Participants in the HIV self-testing intervention arms more often reported preference for HIV self-testing compared to standard testing services to support PrEP in both Zambia (P = 0.002) and Uganda (P < 0.001). CONCLUSION: PrEP implementation programs for FSW could consider inclusion of HIV self-testing to reduce the clinic-based HIV testing burden. TRIAL REGISTRATION: ClinicalTrials.gov NCT02827240 and NCT02846402 .

Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial.

BACKGROUND: HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities. METHODS AND FINDINGS: We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants) were randomized to either (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants' median age was 28 years (IQR 24-32). Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing-to understand the intervention effects on frequent testing-and self-reported facility-based testing-to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17-1.51, p < 0.001) and at 4 months (RR 1.14, 95% CI 1.07-1.22, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07-1.31, p = 0.001) and at 4 months (RR 1.03, 95% CI 1.01-1.05, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in ART initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, 95% CI 1.29-1.77, p < 0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.08-1.37, p = 0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings. CONCLUSIONS: In this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. We found that direct provision of HIV self-tests was significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities. HIV self-testing could play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment as prevention, behavior change for transmission reduction, and pre-exposure prophylaxis. TRIAL REGISTRATION: ClinicalTrials.gov NCT02846402.

Knowledge of HIV Status Is Associated With a Decrease in the Severity of Depressive Symptoms Among Female Sex Workers in Uganda and Zambia.

BACKGROUND: Knowledge of HIV-positive status may result in depressive symptoms, which may be a concern to scaling novel HIV testing interventions that move testing outside the health system and away from counselor support. SETTING: Uganda and Zambia. METHODS: We used longitudinal data from 2 female sex worker (FSW) cohorts in Uganda (n = 960) and Zambia (n = 965). Over 4 months, participants had ample opportunity to HIV testing using standard-of-care services or self-tests. At baseline and 4 months, we measured participants' perceived knowledge of HIV status, severity of depressive symptoms (continuous PHQ-9 scale, 0-27 points), and prevalence of likely depression (PHQ-9 scores ≥10). We estimated associations using individual fixed-effects estimation. RESULTS: Compared with unknown HIV status, knowledge of HIV-negative status was significantly associated with a decrease in depressive symptoms of 1.06 points in Uganda (95% CI -1.79 to -0.34) and 1.68 points in Zambia (95% CI -2.70 to -0.62). Knowledge of HIV-positive status was significantly associated with a decrease in depressive symptoms of 1.01 points in Uganda (95% CI -1.82 to -0.20) and 1.98 points in Zambia (95% CI -3.09 to -0.88). The prevalence of likely depression was not associated with knowledge of HIV status in Uganda but was associated with a 14.1% decrease with knowledge of HIV-negative status (95% CI -22.1% to -6.0%) and a 14.3% decrease with knowledge of HIV-positive status (95% CI -23.9% to -4.5%) in Zambia. CONCLUSIONS: Knowledge of HIV status, be it positive or negative, was significantly associated with a decrease in depressive symptoms in 2 FSW populations. The expansion of HIV testing programs may have mental health benefits for FSWs.

Is knowledge of HIV status associated with sexual behaviours? A fixed effects analysis of a female sex worker cohort in urban Uganda.

INTRODUCTION: Female sex workers (FSWs) have strong economic incentives for sexual risk-taking behaviour. We test whether knowledge of HIV status affects such behaviours among FSWs. METHODS: We used longitudinal data from a FSW cohort in urban Uganda, which was formed as part of an HIV self-testing trial with four months of follow-up. Participants reported perceived knowledge of HIV status, number of clients per average working night, and consistent condom use with clients at baseline, one month, and four months. We measured the association between knowledge of HIV status and FSWs' sexual behaviours using linear panel regressions with individual fixed effects, controlling for study round and calendar time. RESULTS: Most of the 960 participants tested for HIV during the observation period (95%) and experienced a change in knowledge of HIV status (71%). Knowledge of HIV status did not affect participants' number of clients but did affect their consistent condom use. After controlling for individual fixed effects, study round and calendar month, knowledge of HIV-negative status was associated with a significant increase in consistent condom use by 9.5 percentage points (95% CI 5.2 to 13.5, p < 0.001), while knowledge of HIV-positive status was not associated with a significant change in consistent condom use (2.5 percentage points, 95% CI -8.0 to 3.1, p = 0.38). CONCLUSIONS: In urban Uganda, FSWs engaged in safer sex with clients when they perceived that they themselves were not living with HIV. Even in communities with very high HIV prevalence, the majority of the population will test HIV-negative. Our results thus imply that expansion of HIV testing programmes may serve as a behavioural HIV prevention measure among FSWs.

HIV self-test performance among female sex workers in Kampala, Uganda: a cross-sectional study.

OBJECTIVE: To evaluate HIV self-testing performance and results interpretation among female sex workers (FSWs) in Kampala, Uganda, who performed unassisted HIV self-testing. METHODS: In October 2016, 104 participants used an oral HIV self-test while under observation by research assistants. Participants were not assisted on HIV self-test use prior to or during testing, and were only given the manufacturer's pictorial and written instructions to guide them. Research assistants recorded if participants completed and/or had difficulties with steps in the HIV self-testing process on a prespecified checklist. Randomly drawn, used HIV self-tests were interpreted by FSWs. We calculated the concordance between FSWs' interpretations of self-test results with those indicated in the manufacturer's instructions. RESULTS: Only 33% (34/104) of participants completed all of the key steps in the HIV self-testing process, and the majority (86%, 89/104) were observed having difficulties with at least one of these steps. Misinterpretation of HIV self-test results were common among FSWs: 23% (12/56) of FSWs interpreted HIV-negative self-test results as HIV positive and 8% (3/37) of FSWs interpreted HIV-positive self-test results as HIV negative. The concordance between FSWs' interpretations of self-test results and that indicated in the instructions was 73% (95% CI 56% to 86%) for HIV-positive self-tests and 68% (95% CI 54% to 80%) for HIV-negative self-tests. CONCLUSIONS: FSWs in Kampala, who performed unassisted HIV self-testing, skipped steps in the HIV self-testing process and had difficulties correctly interpreting self-test results. Training on use and interpretation of HIV self-tests may be necessary to prevent errors in the HIV self-testing process and to avoid the negative consequences of false-positive and false-negative HIV self-test results among FSWs. TRIAL REGISTRATION NUMBER: NCT02846402.