HIV InfectionsNCT04440813
The Risk of HIV Acquisition Among Traditional Healers in South Africa
A study testing Education and Training by Clinicians and Training and Education from Traditional Healers and Clinicians in people with HIV Infections, run by Vanderbilt University Medical Center at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Education and Training by Clinicians and Training and Education from Traditional Healers and Clinicians
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Africa
- Study dates
- 23 Aug 2021to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Risk of HIV Acquisition Among Traditional Healers in South Africa: Implementing Novel Strategies to Improve Protective Behaviors
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Education and Training by Clinicians, Training and Education from Traditional Healers and Clinicians
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Training by CliniciansBehavioural
Training in the use of PPE and education about the risks of blood exposure.
Training and Education from Traditional Healers and CliniciansBehavioural
Training in the use of PPE and education about the risks of blood exposure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Training and Education from Traditional Healers and Clinicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Exposure
Number of Glove Pairs Used Per Razor Blade Used
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start23 Aug 2021
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Witwatersrand, South Africa
- Responsible party
- Principal investigator, Carolyn Audet, Vanderbilt University Medical Center
- Investigators
- Carolyn M Audet, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440813
- Sponsor's protocol ID
- R21AI150302
- Other IDs
- R21AI150302-01
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2020
- Last updated
- 18 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38394119
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of HIV Acquisition Among Traditional Healers in South Africa: Implementing Novel Strategies to Improve Protective Behaviors
- ClinicalTrials.gov ID
- NCT04440813
- Acronym / sponsor ID
- R21AI150302
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Witwatersrand, South Africa
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Posted 22 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinician Training | Active comparator | Behavioral: Education and Training by CliniciansTraditional 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. |
| Healer + Clinician Training | Experimental | Behavioral: Training and Education from Traditional Healers and CliniciansTraditional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and Training by CliniciansTraining in the use of PPE and education about the risks of blood exposure. | Behavioural | Clinician Training |
| Training and Education from Traditional Healers and CliniciansTraining in the use of PPE and education about the risks of blood exposure. | Behavioural | Healer + Clinician Training |
Primary outcome
Blood Exposure
Time frame: 7 months
Number of Glove Pairs Used Per Razor Blade Used
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38394119Audet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn M Audet, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Training by Clinicians and Training and Education from Traditional Healers and Clinicians in people with HIV Infections, run by Vanderbilt University Medical Center at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Exposure (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04440813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.