Clinical trial NCT05282173: Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa
Official title: Training CHWs to Support Re-Engagement in TB/HIV Care in the Context of Depression and Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: 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
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
name: National Institute of Mental Health (NIMH)
First posted: 2022-03-16
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: CHW Stigma Towards Substance Use
timeFrame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)
measure: CHW Stigma Towards Depression
timeFrame: Change between baseline assessment and 6-month follow-up (approximately 6-months post-training)
measure: Training Feasibility
timeFrame: 3-months post-training
measure: Acceptability
timeFrame: 3-months post-training
measure: CHW Training Fidelity
timeFrame: 3-months post-training
Secondary outcomes:
measure: CHW Stigma Towards Substance Use
timeFrame: Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)
measure: CHW Stigma Towards Depression
timeFrame: Change between baseline assessment and 3-month follow-up (approximately 3-months post-training)
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: South African Medical Research Council
state: Western Cape
Study officials:
affiliation: University of Maryland
name: Jessica F Magidson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Research Council, South Africa
name: Bronwyn J Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References: