Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa (Siyakhana)

• ClinicalTrials.gov Identifier: NCT05282173
• Recruitment Status: Recruiting
• First Posted: March 16, 2022
• Last Update Posted: July 7, 2022
• Sponsor: University of Maryland, College Park
• Collaborators: Medical Research Council, South Africa; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): University of Maryland, College Park

Study Description

Brief Summary:

Poor engagement in care contributes to HIV- and TB-related morbidity and mortality in South Africa (SA). Community health workers (CHWs) are frontline lay health workers who work to re-engage patients who are lost to follow-up (LTFU) in HIV/TB care. Patients with depression and substance use (SU) have a greater likelihood of being LTFU in HIV/TB care, and there is evidence that CHWs may exhibit stigma towards these patients. When CHWs have negative attitudes towards these patients, on average they spend less time with these patients, are less likely to implement evidence-based practices, and deliver less patient-centered care. Therefore, this purpose of this study is to examine the implementation and preliminary effectiveness of a brief training ("Siyakhana"). The purpose of this training is to provide CHWs with psychoeducation, skills, and support around working with HIV/TB patients with depression/SU. The investigators will assess the training's implementation and changes in CHWs' stigma towards HIV/TB patients with depression/SU.

Condition or disease	Intervention/treatment	Phase
Substance-Related Disorders; Mental Disorder; Social Stigma; Depression; Treatment Adherence and Compliance; Health Care Utilization; Attitude of Health Personnel; Hiv; Tuberculosis; Mental Health Disorder; Community Health Workers; Health Care Delivery	Behavioral: Siyakhana CHW Training	Not Applicable

Detailed Description:

South Africa (SA) has the highest number of people living with HIV in the world and a high tuberculosis (TB) burden. Poor engagement in care contributes to HIV- and TB-related morbidity and mortality. In this context, community health workers (CHWs) are frontline lay health workers who play a central role in re-engaging patients who are lost to follow-up (LTFU) in HIV/TB care. Even with existing CHW programs focused on re-engaging patients who are LTFU, people with depression, hazardous alcohol use, or other substance use (SU) are particularly susceptible to poor engagement in HIV/TB care and have a greater likelihood of being LTFU. At the moment, CHWs receive minimal, if any, training on depression and SU, and there is some evidence that CHWs may exhibit stigma towards these patients. When CHWs have negative attitudes towards these patients, on average they spend less time with these patients, are less likely to implement evidence-based practices, and deliver less patient-centered care. Therefore, the purpose of this study is to examine the implementation and preliminary effectiveness of a brief training ("Siyakhana") focused on providing CHWs with psychoeducation, skills, and support around working with patients with depression/SU. In a Type 2, hybrid effectiveness-implementation trial, and using a stepped wedge design, the investigators will primarily assess the training's implementation (feasibility, acceptability, and fidelity) and changes in CHWs' stigma towards HIV/TB patients with depression/SU.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This study uses a stepped-wedge design. All groups of CHWs receive both treatment as usual (TAU) and the stigma reduction training ("Siyakhana"). Randomization will dictate the timing/order in which each group receives the Siyakhana training.
• Masking: None (Open Label)
• Masking Description: The staff member who conducts role-play assessments with participants will be minimally involved in the Siyakhana training.
• Primary Purpose: Health Services Research
• Official Title: Training CHWs to Support Re-Engagement in TB/HIV Care in the Context of Depression and Substance Use
• Actual Study Start Date: June 8, 2022
• Estimated Primary Completion Date: July 1, 2023
• Estimated Study Completion Date: August 1, 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Treatment As Usual (TAU); Monitoring of treatment as usual (i.e., routine interactions between community health workers (CHWs) and their patients).
Experimental: Siyakhana CHW Training; The Siyakhana CHW Training is a multi-day group training that aims to reduce stigma around mental health and substance use among CHWs. It integrates psychoeducation around TB/HIV, stigma, depression, and substance use, including countering myths and stereotypes around mental health and substance use; skills for CHW self-care; evidence-based skills for working with patients living with depression and substance use, such as components of motivational interviewing and problem-solving therapy; and exposure to individuals with lived experience of mental health and substance use. The training is a combination of informative presentations, discussions, worksheets/activities, and role-plays aimed at increasing awareness of mental health and substance use, reducing stigma, and improving interactions when working with patients with HIV/TB and mental health and substance use concerns.	Behavioral: Siyakhana CHW Training; Please see arm description.; Other Names: Siyakhana; Siyakhana - C

Outcome Measures

Primary Outcome Measures :

1. CHW stigma towards depression and substance use [ Time Frame: Change between baseline assessment and 3-month follow-up (approximately 3-months post-training) ]
   CHW stigma towards depression measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (more stigma).
2. Training Feasibility [ Time Frame: 3-months post-training ]
   The percentage of training sessions attended across all CHWs. The training will be considered feasible if over 75% of sessions are attended.
3. Acceptability [ Time Frame: 3-months post-training ]
   Acceptability subscale of the John Hopkins D&I Measure, a 12-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings. This measure will specifically assess CHW's perceived satisfaction, relevance, usefulness, comprehension, and comfort level of the training. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating low acceptability and higher scores (closer to 3) indicating higher acceptability.
4. CHW Training Fidelity [ Time Frame: 3-months post-training ]
   20% of CHW role-plays at the 3-month follow-up assessment (approximately 3-months post-training) will be rated using a fidelity assessment based on training components. A fidelity score will be calculated for each rated role-play based on the proportion of training components delivered as intended during role-plays. A final fidelity score, made up of the average of individual fidelity scores, will then be calculated.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• At least 18 years old
• Employed as a CHW through a partner non-governmental organization (NGO) that provides HIV/TB CHW services
• Works with patients who have HIV and TB, some of whom may be struggling with depression or substance use

Exclusion Criteria:

• Unable to complete informed consent or study procedures in English or Xhosa

Contacts and Locations

Contacts

Contact: Jessica F Magidson, PhD; 301-405-5095; jmagidso@umd.edu

Contact: Kristen S Regenauer, MS; 301-405-0899; kregenau@umd.edu

Locations

South Africa

South African Medical Research Council; Recruiting

Cape Town, Western Cape, South Africa

Contact: Bronwyn Myers, PhD Bronwyn.Myers@mrc.ac.za

Contact: Kim Johnson, MA Kim.Johnson@mrc.ac.za

Sponsors and Collaborators

University of Maryland, College Park

Medical Research Council, South Africa

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Jessica F Magidson, PhD; University of Maryland
• Principal Investigator: Bronwyn J Myers, PhD; Medical Research Council, South Africa

More Information

• Responsible Party: University of Maryland, College Park
• ClinicalTrials.gov Identifier: NCT05282173
• Other Study ID Numbers: EC039-10/2021; R34MH122268 ( U.S. NIH Grant/Contract )
• First Posted: March 16, 2022
• Last Update Posted: July 7, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: After all primary analyses are complete, de-identified data will be available per request of outside individual.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: After the study has been complete (all data collected; data analysis only), the Study Protocol, Informed Consent Forms (ICFs), and Statistical Analysis Plan (SAP) will be made available per request of outside individual.
• Access Criteria: Supporting information will be made available per request of outside individuals.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Maryland, College Park:

Substance-Related Disorders; Mental Disorders; Social Stigma; Depression; Treatment Adherence and Compliance; Delivery of Health Care; Attitude of Health Personnel; HIV; Tuberculosis; Health Care Utilization; Mental Health; Global Health; South Africa; Community Health Workers

Additional relevant MeSH terms:

Tuberculosis; Disease; Substance-Related Disorders; Depression; Depressive Disorder; Mental Disorders; Psychotic Disorders; Pathologic Processes; Behavioral Symptoms; Mood Disorders; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chemically-Induced Disorders; Schizophrenia Spectrum and Other Psychotic Disorders