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

NCT06483854 | Recruiting DMC

• 1 other identifier: 1R01MH135738
• Study Type: interventional
• Target: 230,907
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv

Keywords

HIV counseling and testing; traditional healer practitioners

Outcome Measures

Primary Outcomes (1)

• Uptake of HIV counseling and testing

  At 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.

  24 months

Study Arms (2)

Standard of Care

NO INTERVENTION

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

Healer-provided

EXPERIMENTAL

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

Diagnostic Test: HIV counseling and testing from a traditional health practitioner

Interventions

HIV counseling and testing from a traditional health practitioner DIAGNOSTIC_TEST

Healer provided HIV counseling and testing services offered to clients

Healer-provided

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Witwatersrand, South Africa: collaborator
• Vanderbilt University Medical Center: lead

Study Sites (1)

Bushbuckridge

Agincourt, MP, South Africa

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Carolyn Audet, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn M Audet, PhD

CONTACT

6153432118; carolyn.m.audet@vumc.org

Ryan Wagner, PhD

CONTACT

ryan.wagner@wits.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 3, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)