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Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in South African HIV Care
NA trial testing Siyakhana - P in Substance-Related Disorders in 91 participants. Completed in 29 August 2024.
| Lead sponsor | University of Maryland, College Park |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 91 |
| Start date | 22 February 2021 |
| Primary completion | 29 January 2024 |
| Estimated completion | 29 August 2024 |
| Sites | 1 location across South Africa |
University of Maryland, College Park
18 and older, any sex, with Substance-Related Disorders or Substance Use. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| Enhanced Treatment as Usual (Healthcare Workers) | 11.63 | ± 2.87 |
| Siyakhana - P (Healthcare Workers) | 9.95 | ± 2.93 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Siyakhana - P (Healthcare Workers) | 2.35 | ± 0.63 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Siyakhana - P (Healthcare Workers) | 2.46 | ± 0.58 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Siyakhana - P (Patients) | 2.77 | ± 0.24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Siyakhana - P (Patients) | 2.86 | ± 0.28 |
Time frame: Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Enhanced Treatment as Usua… | Siyakhana - P (Healthcare … | Enhanced Treatment as Usua… | Siyakhana - P (Patients) |
|---|---|---|---|---|---|
| Death | General disorders | — | — | — | — |
| Hospitalization | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | Enhanced Treatment as Usua… | Siyakhana - P (Healthcare … | Enhanced Treatment as Usua… | Siyakhana - P (Patients) |
|---|---|---|---|---|---|
| Birth in hospital, infant death | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Suicidal Thoughts | Psychiatric disorders | — | — | — | — |
Most-reported serious reactions: Death, Hospitalization.
Data from ClinicalTrials.gov NCT05907174 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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