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

Depression Clinical Trial

— Siyakhana  

Official title:

Training CHWs to Support Re-Engagement in TB/HIV Care in the Context of Depression and Substance Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05282173
• Other study ID #: EC039-10/2021
• Secondary ID: R34MH122268
• Status: Completed
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2024
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attitude of Health Personnel
• Community Health Workers
• Depression
• Depressive Disorder
• Health Care Delivery
• Health Care Utilization
• Hiv
• Mental Disorder
• Mental Disorders
• Mental Health Disorder
• Psychotic Disorders
• Social Stigma
• Substance-Related Disorders
• Treatment Adherence and Compliance
• Tuberculosis

Intervention

Behavioral:
• Siyakhana CHW Training
Please see arm description.

Locations

Country	Name	City	State
South Africa	South African Medical Research Council	Cape Town	Western Cape

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, College Park	Medical Research Council, South Africa, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHW stigma towards substance use	CHW 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 (more stigma).	Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)
Primary	CHW stigma towards depression	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).	Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)
Primary	Training Feasibility	The percentage of training sessions attended across all CHWs. The training will be considered feasible if over 75% of sessions are attended.	3-months post-training
Primary	Acceptability	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.	3-months post-training
Primary	CHW Training Fidelity	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.	3-months post-training
Secondary	CHW stigma towards substance use	CHW 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 (more stigma).	Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)
Secondary	CHW stigma towards depression	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).	Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)