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Clinical Trials/NCT05282173
NCT05282173
Completed
Not Applicable

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

University of Maryland, College Park1 site in 1 country82 target enrollmentJune 8, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance-Related Disorders
Sponsor
University of Maryland, College Park
Enrollment
82
Locations
1
Primary Endpoint
CHW Stigma Towards Substance Use
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 8, 2022
End Date
August 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

CHW Stigma Towards Substance Use

Time Frame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)

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).

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) randomly selected for rating using the ENhancing Assessment of Common Therapeutic factors (ENACT) tool, a 15-item validated measure of fidelity and clinical competence among non-specialist workers, by two independent bilingual assessors. Ratings were given for 15 clinical competencies, giving scores of 1 (harmful), 2 (some basic skills), 3 (all basic skills), or 4 (advanced skills). CHW fidelity scores were calculated based on ENACT items rated as delivered with competence. A cut-off of ≥2 (some basic skills) was used to define fidelity for each item.

CHW Stigma Towards Depression

Time Frame: Change between baseline assessment and 6-month follow-up (approximately 6-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

Time Frame: 3-months post-training

The number of CHWs who attended all three days of the Siyakhana training. The training will be considered feasible if over 75% of CHWs attend the full training.

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.

Secondary Outcomes

  • CHW Stigma Towards Depression(Change between baseline assessment and 3-month follow-up (approximately 3-months post-training))
  • CHW Stigma Towards Substance Use(Change between baseline assessment and 3-month follow-up (approximately 3-months post-training))

Study Sites (1)

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