Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in South African HIV Care

HIV Clinical Trial

Official title:

Evaluating the Role of Peers to Reduce Substance Use Stigma and Improve HIV Care Outcomes in South Africa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05907174
• Other study ID #: EC016-7/2022
• Secondary ID: R21DA053212
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alcohol and other drug use is common among people living with HIV in South Africa and is associated with worse engagement in HIV care. There is evidence that healthcare workers in this setting, including community health workers who play a central role in re-engaging patients back into HIV care, exhibit stigmatizing behaviors towards HIV patients who use substances. In general, healthcare worker stigma towards alcohol and other drug use is associated with poorer treatment of patients who use substances, and in this setting, healthcare worker stigma towards alcohol and other drug use has been associated with worse patient engagement in HIV care. In the United States, peer recovery coaches (PRCs), who are trained individuals with lived substance use recovery experience, have helped patients who use substances engage in healthcare. Theoretically, integrating a PRC onto a healthcare team also increases healthcare worker contact with a person with substance use experience, which may be associated with lower stigma. Yet, a PRC model has not yet been tested in South African HIV care. Therefore, the purpose of this study is to develop and pilot a PRC model integrated into community-based primary care teams providing HIV services in South Africa. The study aims to compare a healthcare team with a PRC to a team without a PRC. The investigators will primarily assess the implementation of this PRC model and rates of patient re-engagement in care.

Description:

South Africa has the most people living with HIV in the world, many of whom use alcohol and other drugs. Alcohol and other drug use is associated with worse HIV care engagement, contributing to increased HIV-related morbidity and mortality. Healthcare worker stigma towards alcohol and other drug use is associated with poorer treatment of patients who use substances and worse patient engagement in HIV care. There is evidence that healthcare workers in this setting, including community health workers who play a central role in re-engaging patients who are lost to follow-up from HIV care, exhibit stigmatizing behaviors towards HIV patients who use substances. Peer recovery coaches (PRCs) are trained individuals with lived substance use recovery experience who are integrated into healthcare teams. Healthcare workers who work with PRCs have sustained contact with a person with lived substance use experience, which is associated with lower stigma. In the United States, preliminary research has demonstrated that PRCs can be successfully integrated into healthcare teams, and that PRC contact is associated with increased patient engagement in healthcare. Yet, a PRC model has not yet been tested in South African HIV care. Therefore, the purpose of this study is to examine the preliminary implementation and effectiveness of integrating a PRC model into existing teams of healthcare workers who are tasked with re-engaging patients in HIV care through community-based primary care teams. In a type 1, hybrid effectiveness-implementation trial, and comparing a healthcare worker team that works with a PRC to one that does not, the investigators will primarily assess the rate of patient re-engagement in care and implementation (i.e., feasibility, acceptability) of the model. Healthcare worker stigma towards patients living with HIV who use substances will also be measured.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 1, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

1. HEALTHCARE WORKER:

1. Inclusion Criteria:

• At least 18 years old
• Employed as a healthcare worker (e.g., community health worker, nurse, supervisor, etc.,) for one of the partner healthcare worker teams that provides HIV re-engagement services

2. Exclusion Criteria:

• Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans

2. PATIENT:

1. Inclusion Criteria:

• At least 18 years old
• Living with HIV
• Problematic alcohol or other drug use defined by either: a) AUDIT-C score = 2; or b) self-report illicit drug use within past 3 months
• Seen by a healthcare worker from one of the healthcare teams partnered with this study because of recent disengagement in HIV care

2. Exclusion Criteria:

• Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans

Related Conditions & MeSH terms

• Attitude of Health Personnel
• Community Health Workers
• Delivery of Health Care
• Global Health
• Health Care Seeking Behavior
• Health Personnel
• Health Personnel Attitude
• HIV
• Stigma, Social
• Stigmatization
• Substance Use
• Substance Use Disorders
• Substance-Related Disorders
• Treatment Adherence
• Treatment Adherence and Compliance

Intervention

Behavioral:
• Siyakhana - P
A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.

Locations

Country	Name	City	State
South Africa	South African Medical Research Council - Delft Office	Cape Town	Western Cape

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, College Park	Medical Research Council, South Africa, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare Worker Substance Use Stigma	Healthcare worker stigma towards substance use measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (higher stigma).	3-months post-baseline assessment
Secondary	Patient Re-Engagement in HIV Care	Patient HIV care re-engagement (dichotomous yes/no), assessed via clinic records.	3-months post-baseline assessment
Secondary	Healthcare Worker Feasibility (Intervention Arm Only)	Feasibility subscale of the JHU Applied Mental Health Research (AMHR) D&I Measure, a 15-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings, completed by healthcare worker participants. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating lower feasibility and higher scores (closer to 3) indicating higher feasibility. Findings will be supplemented with qualitative interviews.	6-months post-baseline assessment
Secondary	Healthcare Worker Acceptability (Intervention Arm Only)	Acceptability subscale of the JHU Applied Mental Health Research (AMHR) D&I Measure, a 12-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings, completed by healthcare worker participants. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating lower acceptability and higher scores (closer to 3) indicating higher acceptability. Findings will be supplemented with qualitative interviews.	6-months post-baseline assessment
Secondary	Patient Feasibility (Intervention Arm Only)	Feasibility subscale of the JHU Applied Mental Health Research (AMHR) D&I Measure, a 15-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings, completed by patient participants. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating lower feasibility and higher scores (closer to 3) indicating higher feasibility. Findings will be supplemented with qualitative interviews.	3-months post-baseline assessment
Secondary	Patient Acceptability (Intervention Arm Only)	Acceptability subscale of the JHU Applied Mental Health Research (AMHR) D&I Measure, a 12-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings, completed by patient participants. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating lower acceptability and higher scores (closer to 3) indicating higher acceptability. Findings will be supplemented with qualitative interviews.	3-months post-baseline assessment