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

Sponsor

University of Maryland, College Park (Other)

Overall Status

Recruiting

CT.gov ID

NCT05282173

Collaborator

Medical Research Council, South Africa (Other), National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

13.8

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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.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 :

Jun 8, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 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

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

CHW stigma towards depression and substance use [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).
Training Feasibility [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.
Acceptability [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.
CHW Training Fidelity [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	South African Medical Research Council	Cape Town	Western Cape	South Africa

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