Site-randomized Trial of a Novel Social Network Recruitment Intervention to Locate More Undiagnosed Positive Cases of HIV, Increase HIV Testing Among Men, and Reduce HIV-related Stigma in South Africa (E-SNRHT South Africa)

Study Overview. The primary goal of the proposed study is to conduct a site-randomized trial (with Department of Health [DoH] clinics in the Msunduzi region of KwaZulu-Natal, South Africa as sites) to evaluate the efficacy of an expanded social network recruitment to HIV testing (E-SNRHT) intervention that is designed to extend the reach of HIV testing and care to groups and individuals that have been "hard-to-reach" for HIV testing, and to address HIV-related stigma as a barrier to HIV testing. Thirty-two participating DoH clinics will be randomly assigned to either the E-SNRHT intervention condition or to the control condition using urbanicity-stratified random assignment. People with newly-diagnosed HIV (PNDH) will then be recruited at participating clinics as "seeds" (i.e., initial study participants). After conducting brief education to remind them of HIV transmission risks and how HIV transmits through networks, seed participants in the intervention arm only (i.e., seeds recruited from an intervention condition-assigned clinic) will be asked to recruit members of their expanded social networks (e.g., friends, family members, acquaintances) who they think may be at risk of having undiagnosed HIV infection, or may otherwise benefit from HIV testing. All recruited network members will be tested for HIV, and will then be referred to additional HIV services: (i) those who test positive for HIV will be referred to antiretroviral treatment (ART) and offered support with appointment scheduling and navigating the clinic system, and (ii) those who test negative for HIV will be offered support to schedule follow-up HIV testing at 3 months and 6 months post baseline. This intervention not only aims (a) to increase rates of HIV testing and care among groups who test at low rates in this setting (specifically to men, who test in Msunduzi area clinics at much lower rates than women); and (b) to locate previously undiagnosed cases of HIV at higher rates than business as usual clinic testing; but also aims (c) to reduce HIV-related stigma and increase HIV-related social support through the process of peer recruitment, which will facilitate and normalize conversations about HIV and related services among peer networks. All participants will be interviewed and assessed at baseline, and will also be asked to complete 6-month follow-up interviews. A subset of 50 participants who are network members will also be asked to participate in in-depth qualitative interviews about their experiences being recruited to HIV testing by peers and recruiting their peers to HIV testing. Implementation data will also be collected based on the RE-AIM implementation science framework, in order to evaluate implementation success on key RE-AIM outcomes.

Recruitment Coupons. All recruitment of participants' network members in the intervention condition will occur via the distribution of recruitment coupons by participants. Coupons will contain unique, confidential alpha-numeric codes which will not contain any identifying information about the participant, but which will be used to link participants' social network members to them for analytic purposes. To protect participants' privacy, coupons will state only that the study is about "community health." Coupon design and language (and all study materials and procedures) will be reviewed and approved by UIC's and HSRC's IRBs and HSRC's Community Advisory Board (CAB) that HSRC maintains in the study locality, comprised of diverse, representative community stakeholders. The PIs will meet several times with the CAB during the recruitment period to report recruitment rates by site, to ensure there are no concerns with variation in recruitment being indicative of participants' discomfort with recruitment procedures at some sites.

Number and Characteristics of Participants to Be Enrolled. A planned total of 2,480 human subjects will be involved in the proposed research. Of these, 560 will be "seed" participants (i.e., original trial participants) who are newly-diagnosed with HIV (NDH), recruited from "business as usual" HIV testing at 32 Department of Health (DoH) clinics in the Msunduzi region of KwaZulu-Natal, South Africa. The remaining 1,920 participants will be the expanded social network members of intervention arm seeds, who will be recruited to the study by seed participants.

The 32 Department of Health clinics included in the study will include 10 clinics in urban areas, 10 clinics in suburban areas, and 12 clinics in rural areas. These 32 clinics will be randomly assigned to the expanded social network recruitment to HIV testing (E-SNRHT) intervention condition or to the control condition using urbanicity-stratified random assignment to ensure that conditions are balanced within each urbanicity type, before participant enrollment begins. Seed participants and the network members they recruit will therefore be enrolled into the study condition (intervention or control condition) already assigned to the clinic at which they (the seeds) were diagnosed with HIV and recruited to the study.

A planned 15 seeds from each of the 16 intervention clinics and 20 seeds from each of the 16 control clinics (240 intervention seeds + 320 control seeds = 560 total seeds) will be recruited. Seeds recruited from intervention condition clinics will be asked to recruit their expanded social network members to the study, and seeds recruited from control condition clinics will not. Specifically, seeds recruited from intervention clinics will be shown a diagram of how HIV spreads through a community and reminded of potential HIV transmission risk behaviors, and then asked to recruit anyone they know (e.g., friends, family members) who they think might be at risk of having undiagnosed HIV infection, or who they think might otherwise benefit from being tested for HIV, regardless of whether or not they have engaged in any HIV risk behaviors together. By including expanded social network members who participants perceive to be at risk of having undiagnosed HIV infection, this approach aims to broaden the reach of HIV testing to people who have previously been "hard-to-reach" for HIV testing.