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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05079347
Other study ID # 201977
Secondary ID 1R34MH124496-01A
Status Completed
Phase N/A
First received
Last updated
Start date July 22, 2022
Est. completion date December 1, 2023

Study information

Verified date December 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 419
Est. completion date December 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
HIV rapid test
Using a rapid test to assess a patient's HIV status

Locations

Country Name City State
South Africa Thulamahashe Health Facility Thulamahashi Mpumalanga

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability of conducting HIV testing among healers Percent of eligible healers who enroll in the training program 6 weeks
Primary Feasibility of completing HIV testing training Percentage of healers who are able to complete the training program. 1 month
Primary Uptake of HIV treatment (if positive) # of participants who enroll in treatment/ # of participants with a positive test result 6 months
Primary Uptake of HIV re-testing at 6 months if the person tested negative Assess the number of re-tests conducted at the health facility 6 months
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