NCT05079347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

July 22, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 9, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

October 1, 2021

Results QC Date

July 31, 2024

Last Update Submit

October 8, 2024

Conditions

Keywords

HIV testingHIV stigmaTrust in health care provider

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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.

Diagnostic Test: HIV rapid test

Interventions

HIV rapid testDIAGNOSTIC_TEST

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

Healer led HIV testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thulamahashe Health Facility

Thulamahashi, Mpumalanga, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Carolyn Audet
Organization
Vanderbilt University Medical Center

Study Officials

  • Carolyn Audet, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: We will pilot the intervention with a small group of traditional healers who will offer HIV testing to their patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Preventive Medicine

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 15, 2021

Study Start

July 22, 2022

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

October 18, 2024

Results First Posted

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations