The Risk of HIV Acquisition Among Traditional Healers in South Africa

NCT04440813 | Completed Results

• 2 other identifiers: R21AI150302R21AI150302-01
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Blood Exposure

  Number of Glove Pairs Used Per Razor Blade Used

  7 months

Study Arms (2)

Clinician Training

ACTIVE COMPARATOR

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.

Behavioral: Education and Training by Clinicians

Healer + Clinician Training

EXPERIMENTAL

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.

Behavioral: Training and Education from Traditional Healers and Clinicians

Interventions

Education and Training by Clinicians BEHAVIORAL

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

Clinician Training

Training and Education from Traditional Healers and Clinicians BEHAVIORAL

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

Healer + Clinician Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

Ludlow

Ludlow, MPM, South Africa

Location

Related Publications (1)

• Audet CM, Seabi T, Oyekunle T, Hove J, Wagner RG. A individually randomized controlled trial comparing Healer-led vs. clinician- led training to improve personal protective equipment use among traditional healers in South Africa. PLOS Glob Public Health. 2024 Feb 23;4(2):e0002945. doi: 10.1371/journal.pgph.0002945. eCollection 2024.

  PMID: 38394119 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr. Carolyn Audet
• Organization: Vanderbilt University Medical Center

carolyn.m.audet@vumc.org

615-343-2418

Study Officials

• Carolyn M Audet, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 22, 2020
• Study Start: August 23, 2021
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: June 18, 2024
• Results First Posted: March 22, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)