Trial Outcomes & Findings for Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers (NCT NCT03718871)

Results Overview

Primary study outcome was receipt of an HIV test within 90 days of enrollment. In the control arm, this was assessed via self-report at time of 90-day phone call follow up. For intervention arm, the participating healer recorded whether an HIV test was accepted by the participant at the time of the study visit. If the HIV test was accepted and delivered, the healer recorded the result of the test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

500 participants

Primary outcome timeframe

within 3 months following study visit

Results posted on

2021-03-04

Participant Flow

25 traditional healers practicing within an eight-kilometer distance from Mbarara Township were screened for eligibility.

Five healers were excluded due to self-reported weekly volume \<7 patients. Three healers declined to participate because of scheduling conflicts. On August 2, 2019 the remaining 17 healers were randomized into two study arms (9 to intervention, 8 to control. From August 8, 2019-February 7, 2020, 500 participants were enrolled at healer cluster sites

Unit of analysis: Traditional healer practices

Participant milestones

Participant milestones
Measure	Healer Control Arm Patients will undergo protocolized usual care at 8 healer practices, which includes HIV education and a referral to receive voluntary HIV testing at local medical clinics.	Healer HIV Testing Intervention 9 healers will deliver pre-test counseling and offer HIV 1/2 antigen-antibody POC test (Oraquick©) to eligible participants. Post-test counseling will be delivered and those testing positive will be provided information about where to receive linkage to HIV care.
Overall Study STARTED	250 8	250 9
Overall Study COMPLETED	250 8	250 9
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healer Control Arm n=250 Participants Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.	Healer HIV Testing Intervention n=250 Participants HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.	Total n=500 Participants Total of all reporting groups
Age, Continuous	30 years n=250 Participants	28.5 years n=250 Participants	29 years n=500 Participants
Sex: Female, Male Female	145 Participants n=250 Participants	134 Participants n=250 Participants	279 Participants n=500 Participants
Sex: Female, Male Male	105 Participants n=250 Participants	116 Participants n=250 Participants	221 Participants n=500 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Number of participants who completed primary education or lower	139 Participants n=250 Participants	143 Participants n=250 Participants	282 Participants n=500 Participants
Number of participants who are Christian	218 Participants n=250 Participants	237 Participants n=250 Participants	455 Participants n=500 Participants
Number of participants who are married	164 Participants n=250 Participants	142 Participants n=250 Participants	306 Participants n=500 Participants

PRIMARY outcome

Timeframe: within 3 months following study visit

Primary study outcome was receipt of an HIV test within 90 days of enrollment. In the control arm, this was assessed via self-report at time of 90-day phone call follow up. For intervention arm, the participating healer recorded whether an HIV test was accepted by the participant at the time of the study visit. If the HIV test was accepted and delivered, the healer recorded the result of the test.

Outcome measures

Outcome measures
Measure	Healer Control Arm n=250 Participants Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.	Healer HIV Testing Intervention n=250 Participants HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
Number of TH Clients Who Received HIV Testing	57 Participants	250 Participants

SECONDARY outcome

Timeframe: within three months following enrollment.

For intervention arm participants, the healer recorded the result of the point-of-care HIV test for those participants who agreed to test during the study visit. In the control arm, this outcomes was assessed via self-report during the 90-day follow up phone call.

Outcome measures

Outcome measures
Measure	Healer Control Arm n=250 Participants Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.	Healer HIV Testing Intervention n=250 Participants HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
Number of New HIV Diagnoses Among TH Clients	0 Participants	10 Participants

SECONDARY outcome

Timeframe: at three months following enrollment.

Population: Zero participants in the control arm were newly diagnosed with HIV infection.

This outcome was assessed via self-report during the 90-day follow up phone call. For participants newly testing HIV-positive, questions were posed to determine if they had received confirmatory testing, and initiated ART medication.

Outcome measures

Outcome measures
Measure	Healer Control Arm n=250 Participants Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.	Healer HIV Testing Intervention n=250 Participants HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
Number of Patients With +HIV Test Who Successfully Link to HIV Care	0 Participants	7 Participants

SECONDARY outcome

Timeframe: 3 months following study enrollment

Population: Only control arm participants who received an HIV test were included in this analysis, as all intervention arm participants accepted an HIV test as part of the study and therefore, no other variates would be statistically associated with receiving a test more than being in the intervention study arm.

Participants in the control arm assessed for primary outcomes of receiving an HIV test within 3 months of study enrollment. Participant age in years at time of study enrollment, and association with primary outcome of receiving an HIV test

Outcome measures

Outcome measures
Measure	Healer Control Arm n=57 Participants Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.	Healer HIV Testing Intervention HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
Age in Years of Control Arm Subjects Who Received an HIV Test	30 years Interval 24.0 to 39.0	—

SECONDARY outcome

Timeframe: at 3 months following enrollment

Population: Participants in the control arm assessed for primary outcomes of receiving an HIV test within 3 months of study enrollment. Only control arm participants were included in this analysis, as all intervention arm participants accepted an HIV test as part of the study and therefore, no other variates would be statistically associated with receiving a test more than being in the intervention study arm.

Self-reported participant gender and association with primary study outcome of receiving an HIV test

Outcome measures

Outcome measures
Measure	Healer Control Arm n=57 Participants Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.	Healer HIV Testing Intervention HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
Gender of Control Arm Subjects Who Received an HIV Test Males	17 Participants	—
Gender of Control Arm Subjects Who Received an HIV Test Females	40 Participants	—

SECONDARY outcome

Timeframe: at 3 months following study enrollment

Population: We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.

Participant self-reported highest level of education, and association with study primary outcome of receiving an HIV test

Outcome measures

Outcome measures
Measure	Healer Control Arm n=57 Participants Patients will undergo protcolized usual care at 8 healer practices, which include HIV education and a referral to receive VCT through local HIV testing clinics. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.	Healer HIV Testing Intervention HIV testing at traditional healer practices: HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered.
Highest Level of Education for Control Arm Subjects Who Received an HIV Test Primary school education or lower	30 Participants	—
Highest Level of Education for Control Arm Subjects Who Received an HIV Test Secondary school education or higher	27 Participants	—

Adverse Events

Healer Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healer HIV Testing Intervention

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

Dr. Radhika Sundararajan

Weill Cornell Medicine

Phone: (646) 962-4654

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place