AzTrials
AzTrials

HIV InfectionNCT05079347

Traditional Healer-initiated HIV Counseling and Testing in South Africa

A study testing HIV rapid test in people with HIV Infection, run by Vanderbilt University Medical Center at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infection
What is being tested?
HIV rapid test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
418 participants
Where
1 siteSouth Africa
Study dates
22 Jul 2022to 1 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Africa1 site
  • Thulamahashe Health Facility

    Thulamahashi, Mpumalanga

Other trials in South Africa

About this study

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.

Read the 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.

Conditions
HIV Infection
Being tested
HIV rapid test
Keywords
HIV testing, HIV stigma, Trust in health care provider
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV rapid testDiagnostic test

    Using a rapid test to assess a patient's HIV status

Study groups in NCT05079347
Study groupRoleWhat they receive
Healer led HIV testingExperimentalTraditional 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.
Receives: Diagnostic Test: HIV rapid test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Completing HIV Testing Training

    Percentage of healers who are able to complete the training program.

    Measured: 1 month

  2. Uptake of HIV Testing

    the percentage of people who are accept testing/ approached to complete testing

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start22 Jul 2022
  3. Primary completion1 Sep 2023
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079347
Sponsor's protocol ID
201977
Other IDs
1R34MH124496-01A1
Status last verified
Oct 2024
First submitted
1 Oct 2021
Last updated
18 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HIV rapid test in people with HIV Infection, run by Vanderbilt University Medical Center at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Completing HIV Testing Training (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in