Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol.
ABSTRACT: INTRODUCTION:A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa. METHODS AND ANALYSIS:A three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants 'seeds' to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip. ETHICS AND DISSEMINATION:This study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990-1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications. TRIAL REGISTRATION NUMBER:NCT03751826; Pre-results.
Project description:BACKGROUND:HIV self-testing (HIVST) addresses barriers to HIV diagnosis among men, but current approaches to distributing HIVST kits only reach a subset of the men requiring testing. METHODS:We conducted a pilot trial of the secondary distribution of HIVST kits through peer networks in fishing communities of Buliisa district (Uganda). We recruited distributors ("seeds") among male patients of a health facility, and among community members. Seeds were trained in HIVST and asked to distribute up to five kits to their peers ("recruits"). Recruits were referred to the study using a coupon, and asked to return the HIVST kit (used or unused). The accuracy of HIVST was measured against a confirmatory test conducted by a health worker. We conducted audio computer assisted self-interviews to measure the occurrence of adverse events, and evaluate the potential yield of peer-delivered HIVST. We also assessed how seeds and recruits rated their experience with peer-distributed HIVST. RESULTS:Nineteen seeds offered an HIVST kit to 116 men, and 95 (81.9%) accepted the offer. No recruit reported coercion, but two seeds experienced hostility from recruits or their family members. The sensitivity of peer-distributed HIVST, as interpreted by recruits, was 100%, and its specificity was 92.8%. Among recruits, 29 had never tested (25.8%), and 42 (44.2%) had tested more than a year ago. Three men living with HIV learned their status through peer-distributed HIVST (yield = 1 new diagnosis per 6.3 seeds). Most recruits (85/88) and seeds (19/19) reported that they would recommend HIVST to their friends and family. All seeds stated that they would accept acting as peer distributors again. CONCLUSIONS:This novel peer-based distribution model of HIVST is safe, and has high uptake. It could help reduce the gender gap in HIV testing in under-served fishing communities in Uganda and elsewhere.
Project description:BACKGROUND:Despite efforts to improve HIV testing and linkage to HIV care among adolescents, young people and adult men, uptake rates remain below global targets. We conducted formative research to generate data necessary to inform the design of a peer-led HIV self-testing (HIVST) intervention intended to improve HIV testing uptake and linkage to HIV care in Kasensero fishing community in rural Uganda. METHODS:This qualitative study was conducted in three study communities in Kasensero fishing community in Rakai district, Uganda, in May 2019. Six single-sex focus group discussions (FGDs) comprising 7-8 participants were conducted with adolescents and young people (15-24?years) and adult men (25+ years). We collected data on people's perceptions about peer-led HIVST; potential acceptability of a peer-led HIVST intervention and suggestions on how to improve linkage to HIV care after a positive HIVST result. Peer-led HIVST was defined as an approach where trained lay people distribute HIVST kits to other people in the community. FGDs were audio-recorded with permission from the participants, transcribed verbatim and analysed manually following a thematic framework approach. RESULTS:Forty-seven participants (31 men and 16 women) participated in the FGDs. Across communities and age-groups, most participants mentioned that peer-led HIVST would be generally acceptable to people in the fishing community but people will need support in performing the test due to fear of performing the test wrongly or failing to cope with HIV-positive results. Most participants felt that peer-led HIVST would bring HIV testing services closer to the community "because [the peer-leader] could be my immediate neighbour", making it easier for people to obtain the kits at any time of their convenience. To improve linkage to HIV care, participants felt that the use of peer-leaders to deliver the initial ART dose to self-tested HIV-positive individuals would be more preferable to the use of community-based ART groups or home-based ART initiation. CONCLUSION:Our study shows that peer-led HIVST is potentially acceptable in the fishing community. These findings suggest that this approach can improve uptake of HIV testing and linkage to HIV care services among populations that are usually missed through conventional HIV testing services.
Project description:BACKGROUND:Novel interventions are needed to reach young people and adult men with HIV services given the low HIV testing rates in these population sub-groups. We assessed the feasibility and acceptability of a peer-led oral HIV self-testing (HIVST) intervention in Kasensero, a hyperendemic fishing community (HIV prevalence: 37-41%) in Rakai, Uganda. METHODS:This study was conducted among young people (15-24 years) and adult men (25+ years) between May and August 2019. The study entailed distribution of HIVST kits by trained "peer-leaders," who were selected from existing social networks and trained in HIVST distribution processes. Peer-leaders received up to 10 kits to distribute to eligible social network members (i.e. aged 15-24 years if young people or 25+ years if adult man, not tested in the past 3 months, and HIV-negative or of unknown HIV status at enrolment). The intervention was evaluated against the feasibility benchmark of 70% of peer-leaders distributing up to 70% of the kits that they received; and the acceptability benchmark of >80% of the respondents self-testing for HIV. RESULTS:Of 298 enrolled into the study at baseline, 56.4% (n = 168) were young people (15-24 years) and 43.6% (n = 130) were adult males (25+ years). Peer-leaders received 298 kits and distributed 296 (99.3%) kits to their social network members. Of the 282 interviewed at follow-up, 98.2% (n = 277) reported that they used the HIVST kits. HIV prevalence was 7.4% (n = 21). Of the 57.1% (n = 12) first-time HIV-positives, 100% sought confirmatory HIV testing and nine of the ten (90%) respondents who were confirmed as HIV-positive were linked to HIV care within 1 week of HIV diagnosis. CONCLUSION:Our findings show that a social network-based, peer-led HIVST intervention in a hyperendemic fishing community is highly feasible and acceptable, and achieves high linkage to HIV care among newly diagnosed HIV-positive individuals.
Project description:INTRODUCTION:In South Africa, HIV-infected men are less likely than women to test and know their status (the first UNAIDS "90-90-90" target), and men have worse outcomes across the HIV care cascade. HIV self-testing (HIVST) may address this testing disparity but questions remain over the most effective distribution strategy and linkage following a positive test result. We implemented a men-focused HIVST distribution programme to evaluate components contributing to participation and retention. METHODS:We conducted an implementation study of multi-venue HIVST kit distribution in rural and peri-urban KwaZulu-Natal (KZN), South Africa. We distributed HIVST kits at community points, workplaces and social venues for on site or take-home use. Clients could choose blood-based or oral-fluid-based HIVST kits and elect to watch an in-person or video demonstration. We provided a USD2 incentive to facilitate reporting test results by phone or SMS. Persons with reactive HIVST results were provided immediate confirmatory tests (if used HIVST on site) or were referred for confirmatory testing (if took HIVST off site) and linkage to care for ART initiation. We describe the testing and linkage cascade in this sample and describe predictors of reactive HIVST results and linkage. RESULTS:Between July and November 2018, we distributed 4496 HIVST kits in two regions of KZN (96% to men, median age 28 (IQR 23 to 35). Most participants (58%) chose blood-based HIVST and 42% chose oral-swab kits. 11% of men were testing for the first time. A total of 3902 (83%) of testers reported their test result to the study team, with 314 (8%) screening positive for HIV. Among 274 men with reactive HIVST results, 68% linked to ART; no significant predictors of linkage were identified. 10% of kit users reported they would prefer a different type (oral vs. blood) of kit for repeat testing than the type they used. CONCLUSIONS:HIVST is acceptable to men and rapid distribution with optional testing support is feasible in rural and peri-urban settings. HIVST kits successfully reached younger men and identified undetected infections. Both oral and blood-based HIVST were selected. Scaling up HIVST distribution and guidance may increase the number of first-time testers among men and help achieve the first UNAIDS "90" for men in South Africa.
Project description:OBJECTIVE:We sought to evaluate whether HIV-positive adults in Malawi were willing to distribute HIV self-testing (HIVST) kits to their sexual partners of unknown HIV status (index HIVST). DESIGN:A mixed-methods study was nested within a larger HIVST trial conducted at 15 health facilities in Malawi. Exit surveys were conducted with HIV-positive adults during routine outpatient department visits to assess perceived acceptability of index partner HIVST versus standard partner referral slips that request partner(s) to attend the health facility. Individuals were included in the sub-analysis irrespective of date of HIV diagnosis or ART initiation (or non-initiation). In-depth interviews were conducted with a sub-sample of respondents. RESULTS:404 HIV-positive adults completed a survey (159 male and 245 female); 21 completed in-depth interviews. Respondents reported feeling more comfortable distributing HIVST versus partner referral slips to their partners (90% vs. 81%) and expressed confidence that their partners would test using HIVST compared to referral slips (77% vs. 66%). Acceptability of HIVST did not vary by sex. Qualitative data revealed that index HIVST was perceived to be private, convenient, and may strengthen relationships by assisting in serostatus disclosure. There were minimal fears of adverse events. Reported barriers to index HIVST included lack of trust within the relationship and harmful gender norms. CONCLUSIONS:HIV-positive clients were willing to distribute HIVST kits to their sexual partners of unknown serostatus. Additional studies are needed to evaluate use of HIVST by index partners, positivity, linkage to care, and adverse events related to index partner HIVST, such as coercion to test among index partners or interpersonal violence among index clients.
Project description:INTRODUCTION:One-in-three men who have sex with men (MSM) in Uganda have never tested for HIV. Peer-driven HIV testing strategies could increase testing coverage among non-testers. We evaluated the yield of peer distributed HIV self-test kits compared with standard-of-care testing approaches in identifying undiagnosed HIV infection. METHODS:From June to August 2018, we conducted a pilot study of secondary distribution of HIV self-testing (HIVST) through MSM peer networks at The AIDS Support Organization (TASO) centres in Entebbe and Masaka. Peers were trained in HIVST use and basic HIV counselling. Each peer distributed 10 HIVST kits in one wave to MSM who had not tested in the previous six months. Participants who tested positive were linked by peers to HIV care. The primary outcome was the proportion of undiagnosed HIV infections. Data were analysed descriptively. RESULTS:A total of 297 participants were included in the analysis, of whom 150 received HIVST (intervention). The median age of HIVST recipients was 25 years (interquartile range [IQR], 22-28) compared to 28 years IQR (25-35) for 147 MSM tested using standard-of-care (SOC) strategies. One hundred forty-three MSM (95%) completed HIVST, of which 32% had never tested for HIV. A total of 12 participants were newly diagnosed with HIV infection: 8 in the peer HIVST group and 4 in the SOC group [5.6% vs 2.7%, respectively; P = 0.02]. All participants newly diagnosed with HIV infection received confirmatory HIV testing and were initiated on antiretroviral therapy. CONCLUSION:Peer distribution of HIVST through MSM networks is feasible and effective and could diagnose more new HIV infections than SOC approaches. Public health programs should consider scaling up peer-delivered HIVST for MSM.
Project description:BACKGROUND:Nearly half of Kenyan men with HIV-positive partners do not know their partner's status. We carried out a qualitative substudy to explore the experiences of a sample of HIV-positive women when distributing HIV self-tests (HIVST) to their sexual partners. METHODS:HIV-positive women were invited for in-depth interviews to share their experiences in offering HIVST to their partners and how self-testing impacted their relationships. RESULTS:Two hundred ninety-seven women were randomized to HIVST, 12 of whom self-reported being HIV positive and 11 participated in the interview. Self-testing procedures and interpretation of results were well understood. Participants were strategic in approaching their partners, thus avoided partner violence. Couple testing was high, which strengthened relationships, improved condom use, and empowered women to make joint decisions concerning their health. CONCLUSIONS:Giving HIV-positive women HIVST kits to distribute to their male partners is feasible and safe. Providers who have challenges reaching male partners with testing should consider HIVST.
Project description:<h4>Background</h4>Achieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention, including the prevention of mother-to-child transmission. We aimed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing.<h4>Methods and findings</h4>We conducted a randomized trial in Kisumu, Kenya, between June 11, 2015, and January 15, 2016. Six hundred antenatal and postpartum women aged 18-39 y were randomized to an HIV self-testing (HIVST) group or a comparison group. Participants in the HIVST group were given two oral-fluid-based HIV test kits, instructed on how to use them, and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple. Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner, a routine practice in many health clinics. The primary outcome was partner testing within 3 mo of enrollment. Among 570 participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%, 258/284) than the comparison group (51.7%, 148/286; difference = 39.1%, 95% CI 32.4% to 45.8%, p < 0.001). Couples testing was also more likely in the HIVST group than the comparison group (75.4% versus 33.2%, difference = 42.1%, 95% CI 34.7% to 49.6%, p < 0.001). No participants reported intimate partner violence due to HIV testing. This study was limited by self-reported outcomes, a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used.<h4>Conclusions</h4>Provision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing. This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing.<h4>Trial registration</h4>ClinicalTrials.gov NCT02386215.
Project description: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.
Project description: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.