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

Know Your Status: A Cluster Randomized Controlled Trial Comparing Healer-initiated HIV Counseling and Testing to Standard of Care in Rural South Africa

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06483854
Enrollment
230907
Registered
2024-07-03
Start date
2024-11-25
Completion date
2028-09-01
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Keywords

HIV counseling and testing, traditional healer practitioners

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.

Interventions

DIAGNOSTIC_TESTHIV counseling and testing from a traditional health practitioner

Healer provided HIV counseling and testing services offered to clients

Sponsors

University of Witwatersrand, South Africa
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Uptake of HIV counseling and testing24 monthsAt the time of a healer visit, we will assess the % of people who receive an HIV test divided by the total number of people who are invited to test and who are eligible.

Countries

South Africa

Contacts

Primary ContactCarolyn M Audet, PhD
carolyn.m.audet@vumc.org6153432118
Backup ContactRyan Wagner, PhD
ryan.wagner@wits.ac.za

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026