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

Primary Purpose

Substance-Related Disorders, Substance Use, Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Siyakhana - P
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance-Related Disorders focused on measuring Substance-Related Disorders, Substance Use, Substance Use Disorders, Social Stigma, Substance Use Stigma, Attitude of Health Personnel, Treatment Adherence and Compliance, Health Care Seeking Behavior, HIV, Mental Health Recovery, Substance Use Recovery, Global Health, South Africa, Health Personnel, Community Health Workers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • South African Medical Research Council - Delft OfficeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Enhanced Treatment as Usual (Healthcare Workers)

Siyakhana - P (Healthcare Workers)

Enhanced Treatment as Usual (Patients)

Siyakhana - P (Patients)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Healthcare Worker Substance Use Stigma
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
Patient HIV care re-engagement (dichotomous yes/no), assessed via clinic records.
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.
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.
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.
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.

Full Information

First Posted
June 7, 2023
Last Updated
June 7, 2023
Sponsor
University of Maryland, College Park
Collaborators
Medical Research Council, South Africa, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05907174
Brief Title
Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in South African HIV Care
Official Title
Evaluating the Role of Peers to Reduce Substance Use Stigma and Improve HIV Care Outcomes in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, College Park
Collaborators
Medical Research Council, South Africa, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Substance-Related Disorders, Substance Use, Substance Use Disorders, Social Stigma, Substance Use Stigma, Attitude of Health Personnel, Treatment Adherence and Compliance, Health Care Seeking Behavior, HIV, Mental Health Recovery, Substance Use Recovery, Global Health, South Africa, Health Personnel, Community Health Workers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Treatment as Usual (Healthcare Workers)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Siyakhana - P (Healthcare Workers)
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Treatment as Usual (Patients)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Siyakhana - P (Patients)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Siyakhana - P
Other Intervention Name(s)
Peer Recovery Coach Integrated Intervention, PRC Integration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healthcare Worker Substance Use Stigma
Description
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).
Time Frame
3-months post-baseline assessment
Secondary Outcome Measure Information:
Title
Patient Re-Engagement in HIV Care
Description
Patient HIV care re-engagement (dichotomous yes/no), assessed via clinic records.
Time Frame
3-months post-baseline assessment
Title
Healthcare Worker Feasibility (Intervention Arm Only)
Description
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.
Time Frame
6-months post-baseline assessment
Title
Healthcare Worker Acceptability (Intervention Arm Only)
Description
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.
Time Frame
6-months post-baseline assessment
Title
Patient Feasibility (Intervention Arm Only)
Description
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.
Time Frame
3-months post-baseline assessment
Title
Patient Acceptability (Intervention Arm Only)
Description
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.
Time Frame
3-months post-baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica F Magidson, PhD
Phone
301-405-5095
Email
jmagidso@umd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen S Regenauer, MS
Phone
301-405-0899
Email
kregenau@umd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica F Magidson, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bronwyn Myers, PhD
Organizational Affiliation
Medical Research Council, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
South African Medical Research Council - Delft Office
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7580
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Johnson, MA
Phone
021 955 1900
Email
kim.johnson@mrc.ac.za
First Name & Middle Initial & Last Name & Degree
Bronwyn Myers, PhD
Email
bronwyn.myers@mrc.ac.za

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After all primary analyses are complete, de-identified data will be available per request of outside individual

Learn more about this trial

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

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