Attitude of Health Personnel, Community Health Workers, Delivery of Health Care, Global Health, Health Care Seeking Behavior, Health Personnel, Health Personnel Attitude, HIV, Mental Health Recovery, South Africa, Stigma, Social, Stigmatization, Substance-Related Disorders, Substance Use, Substance Use Disorders, Substance Use Recovery, Treatment Adherence, Treatment Adherence and Compliance
Conditions
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
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.
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.
Interventions
BEHAVIORALSiyakhana - P
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.
Sponsors
Medical Research Council, South Africa
National Institute on Drug Abuse (NIDA)
University of Maryland, College Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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.
Siyakhana - P: 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. | 21 |
| 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. | 25 |
| 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.
Siyakhana - P: 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. | 25 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 3-Month Assessment | Lost to Follow-up | 1 | 1 | 1 | 1 |
| 3-Month Assessment | Withdrawal by Subject | 0 | 0 | 0 | 1 |
| 6-Month Assessment | Death | 0 | 0 | 3 | 0 |
| 6-Month Assessment | Lost to Follow-up | 0 | 1 | 1 | 1 |
| 6-Month Assessment | Withdrawal by Subject | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Enhanced Treatment as Usual (Healthcare Workers) | Siyakhana - P (Healthcare Workers) | Enhanced Treatment as Usual (Patients) | Siyakhana - P (Patients) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 41.10 years STANDARD_DEVIATION 9.75 | 43.33 years STANDARD_DEVIATION 8.59 | 44.88 years STANDARD_DEVIATION 8.53 | 41.84 years STANDARD_DEVIATION 10.91 | 42.86 years STANDARD_DEVIATION 9.47 |
| Race/Ethnicity, Customized Race Black African | 20 Participants | 18 Participants | 23 Participants | 21 Participants | 82 Participants |
| Race/Ethnicity, Customized Race Coloured (South African category) | 0 Participants | 3 Participants | 2 Participants | 4 Participants | 9 Participants |
| Region of Enrollment South Africa | 20 participants | 21 participants | 25 participants | 25 participants | 91 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 24 Participants | 19 Participants | 83 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 1 / 21 | 3 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 20 | 0 / 21 | 0 / 25 | 2 / 25 |
| serious Total, serious adverse events | 0 / 20 | 1 / 21 | 4 / 25 | 0 / 25 |
Outcome results
Primary
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).
Time frame: 3-months post-baseline assessment
Population: Only healthcare worker participants completed this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Treatment as Usual (Healthcare Workers) | Healthcare Worker Substance Use Stigma | 11.63 score on a scale | Standard Deviation 2.87 |
| Siyakhana - P (Healthcare Workers) | Healthcare Worker Substance Use Stigma | 9.95 score on a scale | Standard Deviation 2.93 |
p-value: 0.023Regression, Linear
Secondary
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.
Time frame: 6-months post-integration assessment
Population: Only healthcare participants in the Siyakhana-P condition completed this measure. Of the n = 20 who completed the 6-month assessment, n = 2 never worked directly with the PRC and therefore did not complete this measure. Therefore, data from n = 18 participants was analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana - P (Healthcare Workers) | Healthcare Worker Acceptability (Intervention Arm Only) | 2.46 score on a scale | Standard Deviation 0.58 |
Secondary
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.
Time frame: 6-months post-integration assessment
Population: Only healthcare participants in the Siyakhana-P condition completed this measure. Of the n = 20 who completed the 6-month assessment, n = 2 never worked directly with the PRC and therefore did not complete this measure. Therefore, data from n = 18 participants was analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana - P (Healthcare Workers) | Healthcare Worker Feasibility (Intervention Arm Only) | 2.35 score on a scale | Standard Deviation 0.63 |
Other Pre-specified
Patient Acceptability (Intervention Arm Only)
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.
Time frame: 3-months post-baseline assessment
Population: Only patient participants in the Siyakhana - P intervention condition completed this measure. Of the n=23 Siyakhana - P patient participants who completed the 3-Month Assessment, n=1 never met with the PRC and therefore did not answer the questions. Therefore, a total of n=22 participants are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana - P (Patients) | Patient Acceptability (Intervention Arm Only) | 2.86 score on a scale | Standard Deviation 0.28 |
Other Pre-specified
Patient Feasibility (Intervention Arm Only)
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.
Time frame: 3-months post-baseline assessment
Population: Only patient participants in the Siyakhana - P intervention condition completed this measure. Of the n=23 Siyakhana - P patient participants who completed the 3-Month Assessment, n=1 never met with the PRC and therefore did not answer the questions. Therefore, a total of n=22 participants are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Siyakhana - P (Patients) | Patient Feasibility (Intervention Arm Only) | 2.77 score on a scale | Standard Deviation 0.24 |
Other Pre-specified
Patient Re-Engagement in HIV Care
Patient HIV care re-engagement (dichotomous yes/no), assessed via clinic records.
Time frame: 3-months post-baseline assessment