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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH124496-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healer led HIV testing | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV rapid test | Diagnostic Test | Using a rapid test to assess a patient's HIV status |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Completing HIV Testing Training | Percentage of healers who are able to complete the training program. | 1 month |
| Uptake of HIV Testing | the percentage of people who are accept testing/ approached to complete testing | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Audet, PhD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thulamahashe Health Facility | Thulamahashi | Mpumalanga | South Africa |
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We only recruited and enrolled the clients of traditional healers. The healers themselves were not considered enrolled. Those who self-reported a positive HIV test were excluded from the study.
Those enrolled were offered HIV testing by the healer. We looked at the uptake of testing; so we have demographic data on those who enrolled (n= 418) but not on those who refused (n=93) or those who self reported being HIV+ (n=64).
Recruitment of healer clients took place between July 22, 2022, to May 31, 2023, at the homes of the traditional healers. Healers were not recruited as they were considered employed by the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. HIV rapid test: Using a rapid test to assess a patient's HIV status |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. HIV rapid test: Using a rapid test to assess a patient's HIV status |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Completing HIV Testing Training | Percentage of healers who are able to complete the training program. | Posted | Count of Participants | Participants | 1 month |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. HIV rapid test: Using a rapid test to assess a patient's HIV status |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Audet | Vanderbilt University Medical Center | 615-343-2418 | carolyn.m.audet@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2022 | Aug 26, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2021 | Oct 1, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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We will pilot the intervention with a small group of traditional healers who will offer HIV testing to their patients
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
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| Primary | Uptake of HIV Testing | the percentage of people who are accept testing/ approached to complete testing | Posted | Count of Participants | Participants | 6 months |
|
|
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| 0 |
| 418 |
| 0 |
| 418 |
| 0 |
| 418 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |