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Traditional Healer-initiated HIV Counseling and Testing in South Africa

Primary Purpose

HIV Infection

Status
Active
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
HIV rapid test
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Infection focused on measuring HIV testing, HIV stigma, Trust in health care provider

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Thulamahashe Health Facility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healer led HIV testing

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 1, 2021
Last Updated
September 29, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05079347
Brief Title
Traditional Healer-initiated HIV Counseling and Testing in South Africa
Official Title
Traditional Healer-initiated HIV Counseling and Testing in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV testing, HIV stigma, Trust in health care provider

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healer led HIV testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
HIV rapid test
Intervention Description
Using a rapid test to assess a patient's HIV status
Primary Outcome Measure Information:
Title
Acceptability of conducting HIV testing among healers
Description
Percent of eligible healers who enroll in the training program
Time Frame
6 weeks
Title
Feasibility of completing HIV testing training
Description
Percentage of healers who are able to complete the training program.
Time Frame
1 month
Title
Uptake of HIV treatment (if positive)
Description
# of participants who enroll in treatment/ # of participants with a positive test result
Time Frame
6 months
Title
Uptake of HIV re-testing at 6 months if the person tested negative
Description
Assess the number of re-tests conducted at the health facility
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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. 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: Traditional healers who do not believe in HIV disease and those who can not pass their HIV counseling and testing certification. Biomedical practitioners who do not interact with patients seeking treatment for HIV. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Audet, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thulamahashe Health Facility
City
Thulamahashi
State/Province
Mpumalanga
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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Traditional Healer-initiated HIV Counseling and Testing in South Africa

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