Healer-initiated HIV Counseling and Testing Versus Standard of Care in Rural South Africa

NCT ID: NCT06483854

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230907 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2028-09-01

Brief Summary

South Africa has made progress towards their 95-95-95 goals, yet a substantial proportion of the population do not test regularly. To reach people who otherwise may avoid testing, we propose to build on our successful healer-initiated HIV counseling and testing pilot to conduct a cluster randomized controlled trial in 42 clinical catchment areas to evaluate an expanded Healer-Initiated HIV Testing and Linkage to Care intervention in rural South Africa.

Detailed Description

South Africa has made progress towards their 95-95-95 goals, yet a substantial proportion of the population do not test regularly. In South Africa, people of low socioeconomic status, men, people in rural areas, and those who distrust the health system have higher rates of HIV stigma and are less likely to receive an HIV test. These individuals are also more likely to see a traditional healer for their health care needs, making healers an ideal group to bridge the health care utilization divide.

To reach people who otherwise may avoid testing, the team trained 15 traditional healers to conduct HIV counseling and testing in their own "clinics"- a hut or room by their home where they provide care to their patients (R34MH122259-01). Over six-months, with no advertisement or community events, healers offered HIV counseling and testing to 463 individuals who visited them for unrelated services. Fifty-four (11.7%) self-reported a positive HIV status. Of the 409 eligible participants, 316 (77%) agreed to test, and 20 (6.3%) tested positive- 95% were linked to HIV care and treatment services.

In collaboration with the Department of Health and the healer's organization, this study will build on a successful pilot to test an expanded Healer-Initiated HIV Testing and Linkage to Care intervention with the following testing and linkage to care components. Healers will provide three testing services: (1) Advertise the availability of free healer-initiated counseling and testing for their clients; (2) Offer partner-based testing services at their facilities or client homes; and (3) Provide monthly community-based testing outreach activities at local events (e.g., sporting events, fairs). In addition to testing, healers will support linkage to care and treatment adherence, offering clients accompaniment to their first clinical appointment, ongoing adherence support/counseling in person or via WhatsApp, and a nurse/community health worker/healer WhatsApp group to facilitate more technical support if needed. This is a cluster randomized controlled trial (comparing standard of care (SOC) testing options vs. SOC + enhanced testing with support of traditional healers) at 42 clinical catchment areas to evaluate the impact this intervention.

The Specific Aims of this study are to: (1) Compare rates of HIV testing in healer-initiated HIV counseling and testing communities vs. control communities via a cluster randomized controlled trial in rural South Africa; (2) Assess adoption, implementation fidelity and maintenance of healer-initiated HIV testing; and (3) Evaluate the cost-effectiveness of healer-initiated HIV counseling and testing compared to standard of care. This team has a proven record of engaging traditional healers to improve patient outcomes, conducting research to evaluate and address mistrust in the health system, HIV stigma, and developing interventions to increase HIV testing uptake. Traditional healers are an untapped resource with the potential to reach those who historically avoid HIV testing and they have the potential to help South Africa reach their 95% testing targets.

Conditions

Hiv

Keywords

HIV counseling and testing; traditional healer practitioners

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Standard of Care

people who receive HIV testing in this arm through standard programs provided by clinics.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healer-provided

Traditional healers will provide HIV counseling and testing services to their clients

Group Type: EXPERIMENTAL

HIV counseling and testing from a traditional health practitioner

Intervention Type: DIAGNOSTIC_TEST

Healer provided HIV counseling and testing services offered to clients

Interventions

HIV counseling and testing from a traditional health practitioner

Healer provided HIV counseling and testing services offered to clients

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Community members > 18 years of age, who chose to receive an HIV test from a traditional healer.

Exclusion Criteria

• Community members who are not of sound mind or body during the recruitment (inebriated, experiencing a mental health issue).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Audet

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Audet, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Bushbuckridge

Agincourt, MP, South Africa

Site Status: RECRUITING

Countries

South Africa

Central Contacts

Carolyn M Audet, PhD

Role: CONTACT

Phone: 6153432118

Email: carolyn.m.audet@vumc.org

Ryan Wagner, PhD

Role: CONTACT

Email: ryan.wagner@wits.ac.za

Facility Contacts

Wonderful Mabuza Mabuza, BA

Role: primary

Other Identifiers

1R01MH135738

Identifier Type: NIH

Identifier Source: org_study_id

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