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

NCT06857071 | Recruiting DMC

• 1 other identifier: R01MH136871
• Study Type: interventional
• Target: 2,480
• Locations: 1 country
• Sites: 1

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.

Conditions

Undiagnosed HIV Infection; Long-term Undiagnosed HIV Infection; Populations That Are Reluctant to Test for HIV; Individuals With Newly-diagnosed HIV Infection; HIV-related Stigma; Access to HIV Testing

Keywords

expanded social network recruitment; social network recruitment to HIV testing; long-term undiagnosed HIV infection; HIV-related stigma; access to HIV testing; newly-diagnosed HIV infection; HIV testing intervention

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  baseline and 6-month follow-up

• 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.

  baseline and 6-month follow-up

• Social experiences related to participation in the study

  To monitor potential harm of the intervention, participants will be asked whether or not they have had any of a specific list of negative social experiences that they believe to be related to their participation in the study.

  baseline and 6-month follow-up

• Community-level HIV-related stigma

  Perceptions of the amount of HIV-related stigma present in participants' communities will be measured using 7 dichotomous items from a measure developed by the PI's previous research team. These items, adapted from the Perceived Stigma of HIV/AIDS: Public Views Scale, ask how likely respondents think people living with HIV are to experience a set of stigmatizing responses from members of their community.

  baseline and 6-month follow-up

Secondary Outcomes (5)

• Individual-level experiences of HIV-related social support

  baseline and 6-month follow-up

• Participant antiretroviral treatment (ART) initiation

  6-month follow-up

• Clinic-level rates of antiretroviral treatment (ART) initiation

  6-month follow-up

• Participant HIV viral suppression

  6-month follow-up

• Clinic-level HIV rates of viral suppression

  6-month follow-up

Study Arms (2)

E-SNRHT Intervention Arm

EXPERIMENTAL

The E-SNRHT intervention arm will recruit people newly diagnosed with HIV as "seeds" from clinics randomly assigned to the intervention condition, 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, whether or not they have engaged in any HIV risk behaviors together. Thus, E-SNRHT aims to broaden the reach of HIV testing to people who are reluctant to participate in risk partner recruitment. 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 for HIV will be referred to 3-month follow-up HIV testing.

Behavioral: Expanded Social Network Recruitment to HIV Testing (E-SNRHT) Intervention

Control Arm

NO INTERVENTION

The control arm consists of usual standard of care HIV testing and treatment at DoH clinics. In this arm, people newly diagnosed with HIV at clinics randomly assigned to the control condition will be recruited as control arm participants. They will be recruited and interviewed, and their HIV viral load will be measured. They will be encouraged to follow up with the clinic at which they were diagnosed for usual standard HIV care.

Interventions

Expanded Social Network Recruitment to HIV Testing (E-SNRHT) Intervention BEHAVIORAL

The 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.

E-SNRHT Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Mental Health (NIMH): collaborator
• NYU Langone Health: collaborator
• Human Sciences Research Council: collaborator

Study Sites (1)

Centre for Community-based Research, Human Sciences Research Council

Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Leslie D. Williams, Ph.D.

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie D. Williams, Ph.D.

CONTACT

312-996-8820; lesliedw@uic.edu

Alastair van Heerden, Ph.D.

CONTACT

alastair.vanheerden@wits.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 4, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 12 months of the publication of the set of papers that address the main specific aims of this study, all data will be compiled in a standard statistical software and available for open access. The data will be available for a minimum of ten years.
• Access Criteria: OpenICPSR© is a secure repository for storing and sharing social and behavioral science research data. To ensure confidentiality and to protect sensitive data, openICPSR© reviews all data to assess disclosure risk and to determine the level of access (open or restricted). Additionally, openICPSR© requires that data users must be granted approval for access, and in cases of restricted data, allows access only via controlled virtual labs. Users of the public use data will be required to register with ICPSR and agree to its Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, by prohibiting attempts to identify study participants, and by requiring immediate reporting of any disclosure of study participant identity. Data users will also be required to agree not to share or redistribute any data downloads.

Locations

ZA (1)