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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA053212 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical Research Council, South Africa | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siyakhana - P | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Re-Engagement in HIV Care | Patient HIV care re-engagement (dichotomous yes/no), assessed via clinic records. | 3-months post-baseline assessment |
| 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. |
HEALTHCARE WORKER:
Inclusion Criteria:
Exclusion Criteria:
PATIENT:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica F Magidson, PhD | University of Maryland, College Park | Principal Investigator |
| Bronwyn Myers, PhD | Medical Research Council, South Africa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South African Medical Research Council - Delft Office | Cape Town | Western Cape | 7580 | South Africa |
After all primary analyses are complete, de-identified data will be available per request of outside individual
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline & COPC Team-Level Randomization |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2024 |
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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.
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| 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. | 6-months post-integration assessment |
| 3-months post-baseline assessment |
| 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. | 3-months post-baseline assessment |
| 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| 3-Month Assessment |
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| 6-Month Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Only healthcare worker participants completed this measure. | Posted | Mean | Standard Deviation | score on a scale | 3-months post-baseline assessment |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6-months post-integration assessment |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6-months post-integration assessment |
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| Other Pre-specified | Patient Re-Engagement in HIV Care | Patient HIV care re-engagement (dichotomous yes/no), assessed via clinic records. | Not Posted | 3-months post-baseline assessment | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-months post-baseline assessment |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-months post-baseline assessment |
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Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | 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. | 1 | 21 | 1 | 21 | 0 | 21 |
| EG002 | 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. | 3 | 25 | 4 | 25 | 0 | 25 |
| EG003 | 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. | 0 | 25 | 0 | 25 | 2 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Death, cause unknown (family/friends reported they did not know the cause of death) |
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| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 5-day hospitalization due to pulmonary tuberculosis (diagnosed during hospital stay). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Birth in hospital, infant death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Pt admitted to hospital to give birth (planned). Infant did not survive. Pt discharged from hospital shortly after. |
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| Suicidal Thoughts | Psychiatric disorders | Non-systematic Assessment | Pt reported suicidal thoughts during a qualitative interview. Study staff accompanied pt to clinic to meet with a psychologist. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Magidson | University of Maryland, College Park | 301-405-5095 | jmagidso@umd.edu |
| Sep 18, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D057545 | Social Stigma |
| D013240 | Stereotyping |
| D000074822 | Treatment Adherence and Compliance |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D015438 | Health Behavior |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Male |
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| Coloured (South African category) |
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| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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