NCT05907174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2024

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 10, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

June 7, 2023

Results QC Date

January 13, 2025

Last Update Submit

February 7, 2025

Conditions

Keywords

Substance-Related DisordersSubstance UseSubstance Use DisordersSocial StigmaSubstance Use StigmaAttitude of Health PersonnelTreatment Adherence and ComplianceHealth Care Seeking BehaviorHIVMental Health RecoverySubstance Use RecoveryGlobal HealthSouth AfricaHealth PersonnelCommunity Health Workers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Healthcare Worker Feasibility (Intervention Arm Only)

    6-months post-integration assessment

  • Healthcare Worker Acceptability (Intervention Arm Only)

    6-months post-integration assessment

Other Outcomes (3)

  • Patient Re-Engagement in HIV Care

    3-months post-baseline assessment

  • Patient Feasibility (Intervention Arm Only)

    3-months post-baseline assessment

  • Patient Acceptability (Intervention Arm Only)

    3-months post-baseline assessment

Study Arms (4)

Enhanced Treatment as Usual (Healthcare Workers)

NO INTERVENTION

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.

Siyakhana - P (Healthcare Workers)

EXPERIMENTAL

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

Enhanced Treatment as Usual (Patients)

NO INTERVENTION

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.

Siyakhana - P (Patients)

EXPERIMENTAL

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

Interventions

Siyakhana - PBEHAVIORAL

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.

Also known as: Peer Recovery Coach Integrated Intervention, PRC Integration
Siyakhana - P (Healthcare Workers)Siyakhana - P (Patients)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South African Medical Research Council - Delft Office

Cape Town, Western Cape, 7580, South Africa

Location

MeSH Terms

Conditions

Substance-Related DisordersSocial StigmaStereotypingTreatment Adherence and CompliancePatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSocial BehaviorBehaviorHealth Behavior

Results Point of Contact

Title
Dr. Jessica Magidson
Organization
University of Maryland, College Park

Study Officials

  • Jessica F Magidson, PhD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR
  • Bronwyn Myers, PhD

    Medical Research Council, South Africa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

February 22, 2021

Primary Completion

January 29, 2024

Study Completion

August 29, 2024

Last Updated

February 10, 2025

Results First Posted

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

After all primary analyses are complete, de-identified data will be available per request of outside individual

Shared Documents
STUDY PROTOCOL, ICF

Locations