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

NCT05907174 — Not applicable, Completed, 91 participants, University of Maryland, College Park

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

RegistryNCT05907174
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, health services research
Enrollment91 (Actual)
SponsorUniversity of Maryland, College Park (Other); collaborators: Medical Research Council, South Africa, National Institute on Drug Abuse (NIDA)
ConditionsSubstance-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
InterventionsSiyakhana - P (Behavioral)
Datesstart 2021-02-22, primary completion 2024-01-29, completion 2024-08-29, first posted 2023-06-18, last updated 2025-02-10
Locations1 site in South Africa

Related Papers Related Patents Related Grants Related Experts
All trials for Substance-Related Disorders All trials for Substance Use All trials of Siyakhana - P

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Enhanced Treatment as Usual (Healthcare Workers)No interventionMonitoring 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)ExperimentalBehavioral: Siyakhana - PProviders 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.
Enhanced Treatment as Usual (Patients)No interventionMonitoring 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)ExperimentalBehavioral: Siyakhana - PPatients 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.
  • Siyakhana - P (Behavioral), also known as Peer Recovery Coach Integrated Intervention, PRC Integration: 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.

+Outcome measures

Primary outcomes

  • 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 24, with higher scores indicating more desired social distance (higher stigma).

Secondary outcomes

  • Healthcare Worker Feasibility (Intervention Arm Only) [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.
  • Healthcare Worker Acceptability (Intervention Arm Only) [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.

Other outcomes

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

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Posted results

Participant flow

MilestoneEnhanced Treatment as Usual (Healthcare Workers)Siyakhana - P (Healthcare Workers)Enhanced Treatment as Usual (Patients)Siyakhana - P (Patients)
Started20212525
Completed20212525
Not completed0000

Outcome results

  • Healthcare Worker Substance Use Stigma (Primary), Mean, score on a scale: Enhanced Treatment as Usual (Healthcare Workers) 11.63 +/- 2.87; Siyakhana - P (Healthcare Workers) 9.95 +/- 2.93; Enhanced Treatment as Usual (Patients) ; Siyakhana - P (Patients) (p 0.023)
  • Healthcare Worker Feasibility (Intervention Arm Only) (Secondary), Mean, score on a scale: Enhanced Treatment as Usual (Healthcare Workers) ; Siyakhana - P (Healthcare Workers) 2.35 +/- 0.63; Enhanced Treatment as Usual (Patients) ; Siyakhana - P (Patients)
  • Healthcare Worker Acceptability (Intervention Arm Only) (Secondary), Mean, score on a scale: Enhanced Treatment as Usual (Healthcare Workers) ; Siyakhana - P (Healthcare Workers) 2.46 +/- 0.58; Enhanced Treatment as Usual (Patients) ; Siyakhana - P (Patients)
  • Patient Re-Engagement in HIV Care (Other pre specified)
  • Patient Feasibility (Intervention Arm Only) (Other pre specified), Mean, score on a scale: Enhanced Treatment as Usual (Healthcare Workers) ; Siyakhana - P (Healthcare Workers) ; Enhanced Treatment as Usual (Patients) ; Siyakhana - P (Patients) 2.77 +/- 0.24
  • Patient Acceptability (Intervention Arm Only) (Other pre specified), Mean, score on a scale: Enhanced Treatment as Usual (Healthcare Workers) ; Siyakhana - P (Healthcare Workers) ; Enhanced Treatment as Usual (Patients) ; Siyakhana - P (Patients) 2.86 +/- 0.28

Adverse events

Time frame: Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.

ArmDeathsSerious adverse eventsOther adverse events
Enhanced Treatment as Usual (Healthcare Workers)0/20 (0.0%)0/20 (0.0%)0/20 (0.0%)
Siyakhana - P (Healthcare Workers)1/21 (4.8%)1/21 (4.8%)0/21 (0.0%)
Enhanced Treatment as Usual (Patients)3/25 (12.0%)4/25 (16.0%)0/25 (0.0%)
Siyakhana - P (Patients)0/25 (0.0%)0/25 (0.0%)2/25 (8.0%)

Serious adverse events by term

TermOrgan systemEnhanced Treatment as Usual (Healthcare Workers)Siyakhana - P (Healthcare Workers)Enhanced Treatment as Usual (Patients)Siyakhana - P (Patients)
DeathGeneral disorders0/201/213/250/25
HospitalizationRespiratory, thoracic and mediastinal disorders0/200/211/250/25

Other adverse events by term

TermOrgan systemEnhanced Treatment as Usual (Healthcare Workers)Siyakhana - P (Healthcare Workers)Enhanced Treatment as Usual (Patients)Siyakhana - P (Patients)
Birth in hospital, infant deathPregnancy, puerperium and perinatal conditions0/200/210/251/25
Suicidal ThoughtsPsychiatric disorders0/200/210/251/25

+Locations (1)

FacilityCityCountryStatus
South African Medical Research Council - Delft OfficeCape Town, Western CapeSouth Africa

+Study documents

+Investigators

+Funding

NIH grants: R21DA053212