The influence of interviewers on survey responses among female sex workers in Zambia.

BACKGROUND: Interviewers can substantially affect self-reported data. This may be due to random variation in interviewers' ability to put respondents at ease or in how they frame questions. It may also be due to systematic differences such as social distance between interviewer and respondent (e.g., by age, gender, ethnicity) or different perceptions of what interviewers consider socially desirable responses. Exploration of such variation is limited, especially in stigmatized populations. METHODS: We analyzed data from a randomized controlled trial of HIV self-testing amongst 965 female sex workers (FSWs) in Zambian towns. In the trial, 16 interviewers were randomly assigned to respondents. We used hierarchical regression models to examine how interviewers may both affect responses on more and less sensitive topics, and confound associations between key risk factors and HIV self-test use. RESULTS: Model variance (ICC) at the interviewer level was over 15% for most topics. ICC was lower for socio-demographic and cognitively simple questions, and highest for sexual behaviour, substance use, violence and psychosocial wellbeing questions. Respondents reported significantly lower socioeconomic status and more sex-work related violence to female interviewers. Not accounting for interviewer identity in regressions predicting HIV self-test behaviour led to coefficients moving from non-significant to significant. CONCLUSIONS: We found substantial interviewer-level effects for prevalence and associational outcomes among Zambian FSWs, particularly for sensitive questions. Our findings highlight the importance of careful training and response monitoring to minimize inter-interviewer variation, of considering social distance when selecting interviewers and of evaluating whether interviewers are driving key findings in self-reported data. TRIAL REGISTRATION: clinicaltrials.gov NCT02827240 . Registered 11 July 2016.

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.

Effect of HIV self-testing on the number of sexual partners among female sex workers in Zambia.

OBJECTIVES: To assess the effect of two health system approaches to distribute HIV self-tests on the number of female sex workers' client and nonclient sexual partners. DESIGN: Cluster randomized controlled trial. METHODS: Peer educators recruited 965 participants. Peer educator-participant groups were randomized 1 : 1 : 1 to one of three arms: delivery of HIV self-tests directly from a peer educator, free facility-based delivery of HIV self-tests in exchange for coupons, or referral to standard-of-care HIV testing. Participants in all three arms completed four peer educator intervention sessions, which included counseling and condom distribution. Participants were asked the average number of client partners they had per night at baseline, 1 and 4 months, and the number of nonclient partners they had in the past 12 months (at baseline) and in the past month (at 1 month and 4 months). RESULTS: At 4 months, participants reported significantly fewer clients per night in the direct delivery arm (mean difference -0.78 clients, 95% CI -1.28 to -0.28, P = 0.002) and the coupon arm (-0.71, 95% CI -1.21 to -0.21, P = 0.005) compared with standard of care. Similarly, they reported fewer nonclient partners in the direct delivery arm (-3.19, 95% CI -5.18 to -1.21, P = 0.002) and in the coupon arm (-1.84, 95% CI -3.81 to 0.14, P = 0.07) arm compared with standard of care. CONCLUSION: Expansion of HIV self-testing may have positive behavioral effects enhancing other HIV prevention efforts among female sex workers in Zambia. TRIAL REGISTRATION: ClinicalTrials.gov NCT02827240.

HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

BACKGROUND: HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. METHODS AND FINDINGS: Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05-1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing. CONCLUSIONS: In this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high. TRIAL REGISTRATION: ClinicalTrials.gov NCT02827240.

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.

Contraceptive use and unplanned pregnancy among female sex workers in Zambia.

OBJECTIVES: Access to reproductive healthcare, including contraceptive services, is an essential component of comprehensive healthcare for female sex workers (FSW). Here, we evaluated the prevalence of and factors associated with contraceptive use, unplanned pregnancy, and pregnancy termination among FSW in three transit towns in Zambia. STUDY DESIGN: Data arose from the baseline quantitative survey from a randomized controlled trial of HIV self-testing among FSW. Eligible participants were 18 years of age or older, exchanged sex for money or goods at least once in the past month, and were HIV-uninfected or status unknown without recent HIV testing (<3 months). Logistic regression models were used to assess factors associated with contraceptive use and unplanned pregnancy. RESULTS: Of 946 women eligible for this analysis, 84.1% had been pregnant at least once, and among those 61.6% had an unplanned pregnancy, and 47.7% had a terminated pregnancy. Incarceration was associated with decreased odds of dual contraception use (aOR=0.46, 95% CI 0.32-0.67) and increased odds of unplanned pregnancy (aOR=1.75, 95% CI 1.56-1.97). Condom availability at work was associated with increased odds of using condoms only for contraception (aOR=1.74, 95% CI 1.21-2.51) and decreased odds of unplanned pregnancy (aOR=0.63, 95% CI 0.61-0.64). CONCLUSIONS: FSW in this setting have large unmet reproductive health needs. Structural interventions, such as increasing condom availability in workplaces, may be useful for reducing the burden of unplanned pregnancy.

Zambian Peer Educators for HIV Self-Testing (ZEST) study: rationale and design of a cluster randomised trial of HIV self-testing among female sex workers in Zambia.

BACKGROUND: HIV testing and knowledge of status are starting points for HIV treatment and prevention interventions. Among female sex workers (FSWs), HIV testing and status knowledge remain far from universal. HIV self-testing (HIVST) is an alternative to existing testing services for FSWs, but little evidence exists how it can be effectively and safely implemented. Here, we describe the rationale and design of a cluster randomised trial designed to inform implementation and scale-up of HIVST programmes for FSWs in Zambia. METHODS: The Zambian Peer Educators for HIV Self-Testing (ZEST) study is a 3-arm cluster randomised trial taking place in 3 towns in Zambia. Participants (N=900) are eligible if they are women who have exchanged sex for money or goods in the previous 1 month, are HIV negative or status unknown, have not tested for HIV in the previous 3 months, and are at least 18 years old. Participants are recruited by peer educators working in their communities. Participants are randomised to 1 of 3 arms: (1) direct distribution (in which they receive an HIVST from the peer educator directly); (2) fixed distribution (in which they receive a coupon with which to collect the HIVST from a drug store or health post) or (3) standard of care (referral to existing HIV testing services only, without any offer of HIVST). Participants are followed at 1 and 4 months following distribution of the first HIVST. The primary end point is HIV testing in the past month measured at the 1-month and 4-month visits. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Boards at the Harvard T.H. Chan School of Public Health in Boston, USA and ERES Converge in Lusaka, Zambia. The findings of this trial will be presented at local, regional and international meetings and submitted to peer-reviewed journals for publication. TRIAL REGISTRATION NUMBER: Pre-results; NCT02827240.