Trial Outcomes & Findings for Traditional Healer-initiated HIV Counseling and Testing in South Africa (NCT NCT05079347)

NCT ID: NCT05079347

Last Updated: 2024-10-18

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

418 participants

Primary outcome timeframe

1 month

Results posted on

2024-10-18

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	418
Overall Study COMPLETED	418
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Traditional Healer-initiated HIV Counseling and Testing in South Africa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healer Led HIV Testing n=418 Participants 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
Age, Continuous	33 years STANDARD_DEVIATION 12.64 • n=99 Participants
Sex: Female, Male Female	214 Participants n=99 Participants
Sex: Female, Male Male	204 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	418 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment South Africa	418 participants n=99 Participants

PRIMARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Healer Led HIV Testing n=17 Participants 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
Feasibility of Completing HIV Testing Training	16 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Healer Led HIV Testing n=418 Participants 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
Uptake of HIV Testing	418 Participants

Adverse Events

Healer Led HIV Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carolyn Audet

Vanderbilt University Medical Center

Phone: 615-343-2418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place