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

Sponsor

University of Maryland, College Park (Other)

Overall Status

Recruiting

CT.gov ID

NCT05907174

Collaborator

Medical Research Council, South Africa (Other), National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

10.4

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Substance-Related Disorders Substance Use Substance Use Disorders Stigma, Social Stigmatization Attitude of Health Personnel Treatment Adherence Treatment Adherence and Compliance Health Care Seeking Behavior HIV Mental Health Recovery Delivery of Health Care Global Health South Africa Health Personnel Attitude Health Personnel Community Health Workers Substance Use Recovery	Behavioral: Siyakhana - P	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study uses a parallel design. Two existing teams of healthcare workers will be randomized 1:1 at the team level to either have a PRC integrated onto their team or to continue their patient care as usual.This study uses a parallel design. Two existing teams of healthcare workers will be randomized 1:1 at the team level to either have a PRC integrated onto their team or to continue their patient care as usual.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 17, 2023

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Enhanced Treatment as Usual (Healthcare Workers) Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
Experimental: Siyakhana - P (Healthcare Workers) Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.	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. Other Names: Peer Recovery Coach Integrated Intervention PRC Integration
No Intervention: Enhanced Treatment as Usual (Patients) Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
Experimental: Siyakhana - P (Patients) Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.	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. Other Names: Peer Recovery Coach Integrated Intervention PRC Integration

Outcome Measures

Primary Outcome Measures

Healthcare Worker Substance Use Stigma [3-months post-baseline assessment]
Healthcare worker stigma towards substance use measured using the Social Distance Scale (SDS). SDS scores range from 6 to 25, with higher scores indicating more desired social distance (higher stigma).

Secondary Outcome Measures

Patient Re-Engagement in HIV Care [3-months post-baseline assessment]
Patient HIV care re-engagement (dichotomous yes/no), assessed via clinic records.
Healthcare Worker Feasibility (Intervention Arm Only) [6-months post-baseline assessment]
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.
Healthcare Worker Acceptability (Intervention Arm Only) [6-months post-baseline assessment]
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.
Patient Feasibility (Intervention Arm Only) [3-months post-baseline assessment]
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.
Patient Acceptability (Intervention Arm Only) [3-months post-baseline assessment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

HEALTHCARE WORKER:
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

Exclusion Criteria:

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

PATIENT:
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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South African Medical Research Council - Delft Office	Cape Town	Western Cape	South Africa	7580

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jessica F Magidson, PhD, University of Maryland, College Park
Principal Investigator: Bronwyn Myers, PhD, Medical Research Council, South Africa