- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907174
Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in South African HIV Care
Evaluating the Role of Peers to Reduce Substance Use Stigma and Improve HIV Care Outcomes in South Africa
Study Overview
Status
Conditions
- Substance-Related Disorders
- HIV
- Substance Use
- Substance Use Disorders
- Treatment Adherence
- Treatment Adherence and Compliance
- Stigmatization
- Delivery of Health Care
- Stigma, Social
- Attitude of Health Personnel
- Community Health Workers
- Health Personnel
- Health Personnel Attitude
- Health Care Seeking Behavior
- Global Health
- Mental Health Recovery
- South Africa
- Substance Use Recovery
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Western Cape
-
Cape Town, Western Cape, South Africa, 7580
- South African Medical Research Council - Delft Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
|
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare Worker Substance Use Stigma
Time Frame: 3-months post-baseline assessment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare Worker Feasibility (Intervention Arm Only)
Time Frame: 6-months post-integration assessment
|
Feasibility subscale of the JHU Applied Mental Health Research (AMHR) D&I Measure, a 10-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-integration assessment
|
|
Healthcare Worker Acceptability (Intervention Arm Only)
Time Frame: 6-months post-integration assessment
|
Acceptability subscale of the JHU Applied Mental Health Research (AMHR) D&I Measure, a 14-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-integration assessment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Re-Engagement in HIV Care
Time Frame: 3-months post-baseline assessment
|
Patient HIV care re-engagement (dichotomous yes/no), assessed via clinic records.
|
3-months post-baseline assessment
|
|
Patient Acceptability (Intervention Arm Only)
Time Frame: 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.
|
3-months post-baseline assessment
|
|
Patient Feasibility (Intervention Arm Only)
Time Frame: 3-months post-baseline assessment
|
Feasibility subscale of the JHU Applied Mental Health Research (AMHR) D&I Measure, a 14-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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jessica F Magidson, PhD, University of Maryland, College Park
- Principal Investigator: Bronwyn Myers, PhD, Medical Research Council, South Africa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- HIV
- Social Stigma
- South Africa
- Substance Use
- Substance-Related Disorders
- Global Health
- Community Health Workers
- Substance Use Disorders
- Health Personnel
- Treatment Adherence and Compliance
- Attitude of Health Personnel
- Substance Use Stigma
- Health Care Seeking Behavior
- Mental Health Recovery
- Substance Use Recovery
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC016-7/2022
- R21DA053212 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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