Clinical trial NCT06483854: Healer-initiated HIV Counseling and Testing Versus Standard of Care in Rural South Africa
Official title: Know Your Status: A Cluster Randomized Controlled Trial Comparing Healer-initiated HIV Counseling and Testing to Standard of Care in Rural South Africa
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hiv
Keywords: HIV counseling and testing
traditional healer practitioners
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
First posted: 2024-07-03
Enrollment: 230907
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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).

Primary outcomes:
measure: Uptake of HIV counseling and testing
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Agincourt
country: South Africa
facility: Bushbuckridge
state: MP
Study officials:
affiliation: Vanderbilt University
name: Carolyn Audet, PhD
role: PRINCIPAL_INVESTIGATOR
References: