We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Traditional Healer-initiated HIV Counseling and Testing in South Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05079347
Recruitment Status : Recruiting
First Posted : October 15, 2021
Last Update Posted : July 8, 2022
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Carolyn Audet, Vanderbilt University Medical Center

Brief Summary:

The objective of this proposal is to conduct a pilot test of a program aimed at training traditional healers to conduct HIV testing and implementing HIV testing among people living in Bushbuckridge, South Africa.

Pilot Healer-initiated HIV testing uptake and linkage to prevention services. Trust in allopathic health care and HIV stigma will be measured among participants at study enrollment and at month seven.

Hypothesis: Healer-initiated HIV counseling and testing (HICT) will increase trust in allopathic health care and reduce HIV stigma.

Condition or disease Intervention/treatment Phase
HIV Infection Diagnostic Test: HIV rapid test Not Applicable

Detailed Description:

Traditional healers see patients who avoid allopathic health services, including those who refuse HIV testing. Patients report a general preference for traditional healers, given their fluency in local language, the length of time they spend with patients, the respect they show patients, the cultural congruity to their diagnosis, and their proximity to the patients. Reports of poor treatment by health care providers are common in SSA, often resulting in patients refusing or delaying allopathic health services and/or seeking alternative health services. Men, immigrants, and those with low SES most frequently report poor treatment at the health facility or report that the health system is not designed for their needs. People who first visit a traditional healer for HIV-associated symptoms before seeking an HIV test are delayed 2.4 times longer in seeking health services than those who do not. Among patients enrolled in HIV care and treatment, a preference for traditional medicine impacts their treatment decisions: patients who report use of both traditional and allopathic services are 45% less likely to enroll in antiretroviral therapy (ART) services.

Healers are respected members of their communities, play an integral role as informal referral agents to the South African health system, and act as supportive providers to patients living with chronic disease, if effectively engaged. In rural South Africa, traditional healers provide physical and psychological services to >80% of the population. There are more than 200,000 traditional healers in South Africa, but only 46,000 registered physicians (> 20:1 ratio) who provide services for a myriad of disease conditions, including HIV, TB, malaria, epilepsy, schizophrenia, and depression. Given the level of trust in the community and the numbers of healers, partnerships may facilitate diagnosis and linkage to care via the creation of unique testing locations. It is up to researchers and health care providers to overcome our own biases and/or prejudices against this workforce to develop an effective strategy to increase testing uptake.

Traditional healers can bridge the testing gap between "non-testers" and the allopathic health system. Traditional healers have been successfully engaged in health systems to promote care linkage among people living with diabetes, TB, HIV, malaria, and mental illness- many of whom initially did not believe in their allopathic diagnosis until a healer convinced them that their condition was not caused by a curse. Those who are hesitant to test need a trusted and culturally concordant provider (traditional healer) to both vouch for and deliver the HIV test, and the same provider to create a bridge to the allopathic health facility, providing a metaphorical "safe space" for the patient while they transition to HIV care. Traditional healers are strongly motivated to play this role for two reasons: (1) Better patient health outcomes are strongly correlated with perceived quality of traditional healer care. Healers do not want to be associated with high levels of morbidity or mortality, as it is bad for business; and (2) Healers are excited at expanding their public health services. As allopathic medical knowledge is disseminated, healer views on disease causation are expanding to include the germ theory of disease. Patients are open to this partnership, given their inclination to ping-pong between the two systems depending on their needs.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: We will pilot the intervention with a small group of traditional healers who will offer HIV testing to their patients
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Traditional Healer-initiated HIV Counseling and Testing in South Africa
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Healer led HIV testing
Traditional healers will offer HIV testing to their patients. They will provide the test result to patients. If the patient is positive they will refer their patients to the health facility via referral form and/or walk them to the clinic (based on patient preference). If the patient is negative, the healer will encourage them to re-test at the health facility in 6 months during an "open house" event where healers will attend to try and de-stigmatize going to the health facility.
Diagnostic Test: HIV rapid test
Using a rapid test to assess a patient's HIV status

Primary Outcome Measures :
  1. Acceptability of conducting HIV testing among healers [ Time Frame: 6 weeks ]
    Percent of eligible healers who enroll in the training program

  2. Feasibility of completing HIV testing training [ Time Frame: 1 month ]
    Percentage of healers who are able to complete the training program.

  3. Uptake of HIV treatment (if positive) [ Time Frame: 6 months ]
    # of participants who enroll in treatment/ # of participants with a positive test result

  4. Uptake of HIV re-testing at 6 months if the person tested negative [ Time Frame: 6 months ]
    Assess the number of re-tests conducted at the health facility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Traditional healers > 18 years of age, who are registered as traditional healers with the government of South Africa, are currently practicing in the Bushbuckridge area, and are trained to provide HIV testing.
  2. Biomedical practitioners > 18 years of age, who are currently providing HIV-related health care services to patients at government or private health facilities in Bushbuckridge.
  3. Community members > 18 years of age, who have not received an HIV test result in the past year and who currently live in Bushbuckridge.

Exclusion Criteria:

  1. Traditional healers who do not believe in HIV disease and those who can not pass their HIV counseling and testing certification.
  2. Biomedical practitioners who do not interact with patients seeking treatment for HIV.
  3. Community members who are not out sound mind or body during the recruitment (inebriated, too sick to leave the house) and community members with a previous positive HIV test result.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05079347

Layout table for location contacts
Contact: Tshegofatso Seabi, MSci +27833202097 Tshegofatso.seabi@wits.ac.za
Contact: Ryan Wagner, PhD +27715860906 Ryan.Wagner@wits.ac.za

Layout table for location information
South Africa
Thulamahashe Health Facility Recruiting
Thulamahashi, Mpumalanga, South Africa
Contact: Ryan Wagner, MD, PhD    +27715860906    Ryan.Wagner@wits.ac.za   
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Mental Health (NIMH)
Layout table for investigator information
Principal Investigator: Carolyn Audet, PhD Vanderbilt University
  Study Documents (Full-Text)

Documents provided by Carolyn Audet, Vanderbilt University Medical Center:
Informed Consent Form  [PDF] January 5, 2021

Layout table for additonal information
Responsible Party: Carolyn Audet, Assistant Professor of Preventive Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT05079347    
Other Study ID Numbers: 201977
1R34MH124496-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolyn Audet, Vanderbilt University Medical Center:
HIV testing
HIV stigma
Trust in health care provider
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases