Trial Outcomes & Findings for The Risk of HIV Acquisition Among Traditional Healers in South Africa (NCT NCT04440813)

NCT ID: NCT04440813

Last Updated: 2024-06-18

Results Overview

Number of Glove Pairs Used Per Razor Blade Used

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 136 participants
• Primary outcome timeframe: 7 months
• Results posted on: 2024-06-18

Participant Flow

Participant milestones

Measure	Clinician Training Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel. Education and Training by Clinicians: Training in the use of PPE and education about the risks of blood exposure.	Healer + Clinician Training Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel. Training and Education from Traditional Healers and Clinicians: Training in the use of PPE and education about the risks of blood exposure.
Overall Study STARTED	69	67
Overall Study COMPLETED	64	62
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Clinician Training Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel. Education and Training by Clinicians: Training in the use of PPE and education about the risks of blood exposure.	Healer + Clinician Training Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel. Training and Education from Traditional Healers and Clinicians: Training in the use of PPE and education about the risks of blood exposure.
Overall Study Lost to Follow-up	5	5

Baseline Characteristics

The Risk of HIV Acquisition Among Traditional Healers in South Africa

Baseline characteristics by cohort

Measure	Clinician Training n=69 Participants Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel. Education and Training by Clinicians: Training in the use of PPE and education about the risks of blood exposure.	Healer + Clinician Training n=67 Participants Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel. Training and Education from Traditional Healers and Clinicians: Training in the use of PPE and education about the risks of blood exposure.	Total n=136 Participants Total of all reporting groups
Age, Continuous	49.1 years STANDARD_DEVIATION 12.64 • n=5 Participants	53 years STANDARD_DEVIATION 14.18 • n=7 Participants	51.0 years STANDARD_DEVIATION 13.51 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	53 Participants n=7 Participants	110 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	69 Participants n=5 Participants	67 Participants n=7 Participants	136 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Africa	69 participants n=5 Participants	67 participants n=7 Participants	136 participants n=5 Participants
HIV knowledge- HIV is caused by curse Answered correctly	42 Participants n=5 Participants	38 Participants n=7 Participants	80 Participants n=5 Participants
HIV knowledge- HIV is caused by curse Answered incorrectly	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 months

Population: Some of the traditional healers did not conduct any traditional vaccinations during the study period, thus our numbers are smaller than the total number of participants

Number of Glove Pairs Used Per Razor Blade Used

Outcome measures

Measure	Clinician Training n=53 Participants Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel. Education and Training by Clinicians: Training in the use of PPE and education about the risks of blood exposure.	Healer + Clinician Training n=60 Participants Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel. Training and Education from Traditional Healers and Clinicians: Training in the use of PPE and education about the risks of blood exposure.
Blood Exposure	1.9 Number of Glove Pairs Used Per Razor Bla Standard Deviation 0.79	1.9 Number of Glove Pairs Used Per Razor Bla Standard Deviation 0.73

Adverse Events

Clinician Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healer + Clinician Training

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. Carolyn Audet

Vanderbilt University Medical Center

Phone: 615-343-2418

Email: carolyn.m.audet@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place