NCT06857071 Expanded Social Network Recruitment to HIV Testing (E-SNRHT) Intervention to Locate Undiagnosed Cases and Reduce HIV-related Stigma

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This trial targets 2,480 participants in total. It began in 2025-09-30 with a primary completion date of 2027-12-01.

Brief Summary

In South Africa's large generalized HIV epidemic, male-to-female transmission comprises a large proportion of transmission events, but men are much less likely to seek HIV testing, and disproportionately remain undiagnosed. HIV-related stigma is a key barrier to recruiting men to HIV testing in South Africa, as they report feeling blamed by their partners and communities for HIV transmission. This barrier must be addressed to increase testing among men and other testing-avoidant people in order to locate "hard-to-reach" undiagnosed cases and make progress towards 95-95-95 goals. Peer recruitment via social networks is an effective mechanism for promoting HIV testing, because people seek health information from peers, and peers influence health behavior norms within networks. However, standard risk network recruitment is limited in that: 1) recruiting one's own risk partners can trigger stigma and blame for HIV; and 2) it excludes people who have not engaged in HIV risk behavior recently and/or who no longer have contact with their risk partners. The Investigative Team for the present study developed an expanded social network recruitment to HIV testing (E-SNRHT) intervention to address these limitations and reduce stigma as a barrier to testing. E-SNRHT asks "seeds" (i.e., initial participants) who have been newly diagnosed with HIV (NDH) to recruit their expanded social network members (i.e., anyone they know) who they think could benefit from HIV testing or could have an undiagnosed HIV infection, tests these network members, and refers them to ART (if positive) or follow-up testing (if negative). By asking participants to recruit non-risk partners, E-SNRHT is designed to increase their comfort and likelihood of recruiting others, especially those who have avoided testing due to stigma. The Investigative Team's two previous pilot studies of E-SNRHT found that it recruits men to HIV testing at much higher rates than standard risk network recruitment; locates people with newly diagnosed HIV (PNDH; i.e., people with previously undiagnosed HIV infection) at a much higher rate per seed than standard risk network recruitment; and recruits people who have not tested in years, have never tested, and/or have not engaged in HIV risk behavior recently but have undiagnosed HIV infection. These pilot studies also found that E-SNRHT reduces HIV-related stigma and increases HIV-related social support among networks; and that 76% of E-SNRHT participants who were NDH started ART within 10 weeks. As participants recruit each other, their discussions help to normalize talking about HIV, thereby improving levels of stigma and support, which in turn should increase HIV service use and improve HIV care cascade outcomes. The present study will conduct a site-randomized trial of E-SNRHT, with 32 Department of Health clinics in KwaZulu-Natal, South Africa serving as sites. This study will compare E-SNRHT clinics to business-as-usual control clinics on: their rates of recruiting men to testing (Aim 1a) and locating PNDH (1b); participants' reports of HIV-related stigma and social support (Aim 2a); and treatment cascade outcomes (2b). Implementation science methods and qualitative methods will also be used to develop best practices (Aim 3) for future scale-up in South Africa and adaptation to other settings.

Eligibility Criteria

"Seeds" (i.e., initial participants in both study arms) will be recruited via referrals from clinics' standard of care HIV testing. To be eligible, seeds must have received a new HIV diagnosis from a study clinic in the last 2 months (i.e., they must be newly diagnosed with HIV infection \[NDH\]), and must have been given a study recruitment coupon by staff at one of these clinics. They will also be screened to ensure that they meet the following additional eligibility criteria: are ≥ 18 years old, are able to be interviewed in English or isiZulu (since over 95% of the population in the Msunduzi region speaks one or both of these languages), are able to give informed consent, and indicate that they reside in the Msunduzi region of KwaZulu-Natal, South Africa. Seeds in the intervention arm (i.e., recruited from intervention condition-assigned clinics) will be asked to recruit their expanded social network members who they think would benefit from testing for HIV. Network members will be eligible to participate if they have a recruitment coupon given to them by a study participant (i.e., if they were recruited by an intervention arm participant); are ≥ 18 years old; able to be interviewed in English or isiZulu; able to give informed consent; and reside in the Msunduzi region. Inclusion Criteria: * Has study recruitment coupon (from clinic or from intervention arm participant) * Is ≥ 18 years old * Is able to be interviewed in English or isiZulu * Is able to give informed consent * Resides in the Msunduzi region Exclusion Criteria: * Does not have study recruitment coupon (from clinic or from intervention arm participant) * Is \< 18 years old * Is not able to be interviewed in English or isiZulu * Is not able to give informed consent * Does not reside in the Msunduzi region

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