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The Risk of HIV Acquisition Among Traditional Healers in South Africa

The Risk of HIV Acquisition Among Traditional Healers in South Africa: Implementing Novel Strategies to Improve Protective Behaviors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04440813
Enrollment
136
Registered
2020-06-22
Start date
2021-08-23
Completion date
2023-01-25
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

Traditional healers, community-based partners with the national health system of South Africa, are exposed to patient blood an average of 1,500 times during their careers due to the practice of delivering herbal remedies via herbs rubbed into dozens of sub-cutaneous cuts. The purpose of this proposal is to compare two implementation strategies to increase consistent use of Personal Protective Equipment (PPE): (1) a health care worker provided training program followed by 3 educational outreach and coaching visits at the healer's place of practice vs. (2) a training and educational outreach initiative led by a team of health care workers and healers who adopted and use PPE on their own (early adopters) to assess their effects on exposure to patient blood. With an HIV prevalence among healers well above that in the baseline population (30% vs. 19%) and HIV prevalence of 59% among those exposed to patient blood, this study will allow the investigators to test a novel implementation strategy for delivering PPE training to prevent new HIV infections among a newly identified high-risk population in a region with the world's highest HIV prevalence.

Detailed description

In South Africa there are an estimated 200,000 traditional healers providing health services. Like allopathic health care workers (HCW), traditional healers are exposed to bloodborne pathogens through the widespread practice of traditional injections, where healers perform dozens of subcutaneous incisions to rub herbs directly into the bloodied skin. 98 percent of healers perform these treatments; they experience an average of 1,500 blood exposures over the course of their lifetime. This high frequency of blood exposure, coupled with treating high-risk patients, can result in an increased risk of patient-to-healer disease transmission if personal protective equipment (PPE) are not used. Healers in South Africa who reported patient blood touched their skin had 2.59 times higher risk of being HIV-positive than those with no exposure (59% vs. 25%); overall healers have a substantially higher HIV prevalence (30%) than the general population (19%). Free PPE are made available at local health facilities, but most healers have low levels of literacy, limited ability to assess blood exposure risk, and have no PPE training. Given these limitations, use of PPE during treatments is inconsistent. A small proportion of healers employ PPE appropriately during each treatment; these early adopter healers suggest PPE use is sustainable in rural sub-Saharan Africa if a healer has the necessary skills, risk assessment training, and encouragement. This proposal compares two implementation strategies to increase PPE use during procedures and decrease the number of injections performed: (1) HCW led education on risk of blood exposure and development of PPE donning, use and doffing skills through a week-long training followed by 3 educational outreach visits at the healer's place of practice vs. (2) Early adopter healer and HCW co-led week-long training followed by 3 educational outreach visits. The investigators hypothesize that the strategy of engaging early adopter healers as trainers will lead to more accurate participant risk assessments, increase participant self-efficacy, and lead to more consistent use of PPE during treatments. The Specific Aims of this study are to: 1. Adapt PPE training using the ADAPT-ITT model; 2. Compare fidelity of PPE training between the HCW-only team versus the healer + HCW team; 3. Compare the effects of two implementation strategies on healer exposure to patient blood. This potentially high-impact intervention is well-suited to the R21 mechanism. While some allopathic providers may recommend an outright ban on the procedure, patients and healers have strongly believed in the efficacy of these treatments for hundreds of years- they are not likely to stop because of a Department of Health recommendation. It is up healthcare workers and governments to overcome their own biases to develop an effective strategy to prevent HIV seroconversion. The team of South African and U.S. investigators has a proven record of HIV research success and specific experience successfully engaging traditional healers, HIV prevention studies, as well as, dissemination and implementation research.

Interventions

BEHAVIORALEducation and Training by Clinicians

Training in the use of PPE and education about the risks of blood exposure.

BEHAVIORALTraining and Education from Traditional Healers and Clinicians

Training in the use of PPE and education about the risks of blood exposure.

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
University of Witwatersrand, South Africa
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. 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 conduct traditional vaccinations. 2. Biomedical practitioners \> 18 years of age, who are currently providing health care services to patients at government or private health facilities in Bushbuckridge. ' 3. Community members \> 18 years of age, who currently live in Bushbuckridge and sought health care services from a traditional healer in the past year.

Exclusion criteria

1. Traditional healers \<18 years of age, who are not registered as traditional healers with the government of South Africa, are not currently practicing, or do not conduct traditional vaccinations on their patients. 2. Biomedical practitioners \< 18 years of age or who are not currently providing health services in the Bushbuckridge area. 3. Community members \< 18 years of age or who do not seek health care services from traditional healers.

Design outcomes

Primary

MeasureTime frameDescription
Blood Exposure7 monthsNumber of Glove Pairs Used Per Razor Blade Used

Countries

South Africa

Participant flow

Participants by arm

ArmCount
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.
69
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.
67
Total136

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up55

Baseline characteristics

CharacteristicTotalClinician TrainingHealer + Clinician Training
Age, Continuous51.0 years
STANDARD_DEVIATION 13.51
49.1 years
STANDARD_DEVIATION 12.64
53 years
STANDARD_DEVIATION 14.18
HIV knowledge- HIV is caused by curse
Answered correctly
80 Participants42 Participants38 Participants
HIV knowledge- HIV is caused by curse
Answered incorrectly
56 Participants27 Participants29 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
136 Participants69 Participants67 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
South Africa
136 participants69 participants67 participants
Sex: Female, Male
Female
110 Participants57 Participants53 Participants
Sex: Female, Male
Male
26 Participants12 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 690 / 67
other
Total, other adverse events
0 / 690 / 67
serious
Total, serious adverse events
0 / 690 / 67

Outcome results

Primary

Blood Exposure

Number of Glove Pairs Used Per Razor Blade Used

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
Clinician TrainingBlood Exposure1.9 Number of Glove Pairs Used Per Razor BlaStandard Deviation 0.79
Healer + Clinician TrainingBlood Exposure1.9 Number of Glove Pairs Used Per Razor BlaStandard Deviation 0.73

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026