Substance-Related DisordersNCT05907174
Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in South African HIV Care
A study testing Siyakhana - P in people with Substance-Related Disorders and Substance Use, run by University of Maryland, College Park at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders, Substance Use, Substance Use Disorders
- What is being tested?
- Siyakhana - P
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSouth Africa
- Study dates
- 22 Feb 2021to 29 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
South African Medical Research Council - Delft Office
Cape Town, Western Cape, 7580
About this study
Official title: Evaluating the Role of Peers to Reduce Substance Use Stigma and Improve HIV Care Outcomes in South Africa
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.
Read the 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.
- Conditions
- Substance-Related Disorders, Substance Use, Substance Use Disorders, Stigma, Social, Stigmatization, Attitude of Health Personnel
- Being tested
- Siyakhana - P
- 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
- Medical subject headings
- Substance-Related Disorders, Social Stigma, Stereotyping, Treatment Adherence and Compliance, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siyakhana - PBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Siyakhana - P |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3-months post-baseline assessment
Secondary outcomes (2)
Healthcare Worker Feasibility (Intervention Arm Only)
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.
Measured: 6-months post-integration assessment
Healthcare Worker Acceptability (Intervention Arm Only)
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.
Measured: 6-months post-integration assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start22 Feb 2021
- Primary completion29 Jan 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jessica Magidson, University of Maryland, College Park
- Investigators
- Jessica F Magidson, PhD, Principal investigator, University of Maryland, College ParkBronwyn Myers, PhD, Principal investigator, Medical Research Council, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907174
- Sponsor's protocol ID
- EC016-7/2022
- Other IDs
- R21DA053212
- Status last verified
- Feb 2025
- First submitted
- 7 Jun 2023
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After all primary analyses are complete, de-identified data will be available per request of outside individual
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Peers to Reduce Substance Use Stigma and Improve HIV Care Outcomes in South Africa
- ClinicalTrials.gov ID
- NCT05907174
- Acronym / sponsor ID
- EC016-7/2022
- Conditions
- Substance-Related Disorders, Substance Use, Substance Use Disorders, Stigma, Social, Stigmatization, Attitude of Health Personnel
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, National Institute on Drug Abuse (NIDA)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: 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 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 | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Siyakhana - PAlso: Peer Recovery Coach Integrated Intervention, PRC IntegrationA 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. | Behavioural | Siyakhana - P (Healthcare Workers), Siyakhana - P (Patients) |
Primary outcome
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).
2 secondary outcomes
Healthcare Worker Feasibility (Intervention Arm Only)
Time frame: 6-months post-integration assessment
Healthcare Worker Acceptability (Intervention Arm Only)
Time frame: 6-months post-integration assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. After all primary analyses are complete, de-identified data will be available per request of outside individual
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica F Magidson, PhD principal investigator
University of Maryland, College Park
Bronwyn Myers, PhD principal investigator
Medical Research Council, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Siyakhana - P in people with Substance-Related Disorders and Substance Use, run by University of Maryland, College Park at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare Worker Substance Use Stigma (time frame: 3-months post-baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.