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临床试验/NCT04440813
NCT04440813已完成不适用

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

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2021年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
Blood Exposure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Blood Exposure

时间窗: 7 months

Number of Glove Pairs Used Per Razor Blade Used

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolyn Audet

Associate Professor

Vanderbilt University Medical Center

研究点 (1)

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