About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Expanded Social Network Recruitment to HIV Testing (E-SNRHT) Intervention
BehavioralThe E-SNRHT intervention will recruit people newly diagnosed with HIV as "seeds," briefly remind them of HIV transmission risks and how HIV spreads through networks, and ask them to recruit people in their expanded social networks (i.e., anyone they know) who they think might benefit from being tested for HIV, regardless of whether or not they have engaged in any HIV risk behaviors together. By including expanded social networks, E-SNRHT aims to broaden the reach of HIV testing to people who are reluctant to participate in risk partner recruitment and/or to seek clinic testing. Network members recruited by a seed will also be asked to recruit additional people they know using the same education and recruitment instructions provided to seeds. All network members will be tested for HIV and provided with pre- and post-test counseling, all participants diagnosed with HIV will be referred to care, and all participants who test negative will be referred to 3-month follow-up HIV testing.
Treatment groups
Trial outcomes
Primary outcomes
Rates of men recruited to HIV testing
Rates of men recruited to HIV testing will be computed at the clinic site level, using routine clinic testing data to calculate proportions of patients tested at control sites during the baseline study enrollment period who are men. At intervention sites, the proportion of all network-recruited participants from each site who are men will be calculated, to facilitate comparison of the E-SNRHT intervention with business as usual clinic testing procedures.
Rates of people newly-diagnosed with HIV by the intervention (i.e., people with previously-undiagnosed HIV infection)
People newly diagnosed with HIV by the intervention (PNDH) will be defined as participants who test positive for HIV, have no recorded previous positive HIV test, and indicate to clinic or study staff that they have never received a positive HIV test result before. Rates of PNDH will be computed at the clinic site level, using routine clinic testing data to calculate proportions of patients tested at control sites during the baseline study enrollment period who are newly diagnosed with HIV (NDH). At intervention sites, the proportion of all network-recruited participants from each site who are NDH will be calculated, to facilitate comparison of the E-SNRHT intervention with business as usual clinic testing procedures.
Individual-level experiences of HIV-related stigma
Participants' direct experiences of HIV-related stigma will be measured using questions adapted from the Investigators' previous study which ask participants whether they have experienced specific stigmatizing behaviors upon someone learning or thinking that they had HIV. This is a set of 9 dichotomous items in which participants indicate whether or not they have experienced each of a set of 5 different types of stigmatizing experiences. The total possible score range is 0-5, with higher values indicating that participants experienced more different types of stigmatizing experiences.
Individual-level enacted HIV-related stigma (measured using HIV Stigma Scale)
Participants' individual experiences of HIV-related stigma will be measured using the enacted stigma items from the HIV Stigma Scale. This scale comprises 10 items rated on a 4-point Likert scale, with possible total scores ranging from 10-40, and with higher scores indicating greater enacted HIV-related stigma.
Secondary outcomes
Individual-level experiences of HIV-related social support
Participants' direct experiences of HIV-related social support will be measured using a) questions adapted from the Investigators' previous study which ask participants whether they have experienced specific helping/ supportive behaviors upon someone learning or thinking that they had HIV.
Participant antiretroviral treatment (ART) initiation
At follow-up, participants who were NDH at baseline will be asked about their ART access and use. These self-report data will be triangulated with clinic reports on individuals' receipt of ART. (Explicit consent will be obtained for this, giving participants the option on consent forms to deny the study access to this information.) These data will be used to calculate the proportion of NDH participants from each site who started ART by six-month follow-up. Measuring these outcomes with individual-level data will address any threat to internal validity due to participants getting HIV treatment at multiple clinics during the follow-up period.
Clinic-level rates of antiretroviral treatment (ART) initiation
Clinic-level proportions of PNDH (diagnosed during the baseline data collection period) who started ART within six months of diagnosis will be measured using routinely-collected clinic-level data.
Participant HIV viral suppression
Results of viral load tests conducted at follow-up will be used to calculate the proportion of NDH participants from each clinic site who achieved viral suppression (\<50 copies/mL). Measuring these outcomes with individual-level data will address any threat to internal validity due to participants getting HIV treatment at multiple clinics during the follow-up period.
Sponsors and contacts
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University of Illinois at Chicago
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Human Sciences Research Council
Collaborator
NYU Langone Health
Collaborator