- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440813
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
Study Overview
Status
Conditions
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:
- Adapt PPE training using the "ADAPT-ITT" model;
- Compare fidelity of PPE training between the HCW-only team versus the healer + HCW team;
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carolyn M Audet, PhD
- Phone Number: +16154809009
- Email: carolyn.m.audet@vanderbilt.edu
Study Contact Backup
- Name: Ryan Wagner, PhD
- Phone Number: +27715860906
- Email: Ryan.Wagner@wits.ac.za
Study Locations
-
-
MPM
-
Ludlow, MPM, South Africa
- Ludlow
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Biomedical practitioners > 18 years of age, who are currently providing health care services to patients at government or private health facilities in Bushbuckridge. '
- 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:
- 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.
- Biomedical practitioners < 18 years of age or who are not currently providing health services in the Bushbuckridge area.
- Community members < 18 years of age or who do not seek health care services from traditional healers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Training in the use of PPE and education about the risks of blood exposure.
|
Experimental: 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 in the use of PPE and education about the risks of blood exposure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Exposure
Time Frame: 7 months
|
Number of Glove Pairs Used Per Razor Blade Used
|
7 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carolyn M Audet, PhD, Vanderbilt University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AI150302 (U.S. NIH Grant/Contract)
- R21AI150302-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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