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

NCT05282173 — Not applicable, Completed, 82 participants, University of Maryland, College Park

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

RegistryNCT05282173, acronym Siyakhana
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, health services research
Enrollment82 (Actual)
SponsorUniversity of Maryland, College Park (Other); collaborators: Medical Research Council, South Africa, National Institute of Mental Health (NIMH)
ConditionsSubstance-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
InterventionsSiyakhana CHW Training (Behavioral)
Datesstart 2022-06-08, primary completion 2023-08-01, completion 2023-08-01, first posted 2022-03-16, last updated 2025-03-06
Locations1 site in South Africa

Related Papers Related Patents Related Grants Related Experts
All trials for Substance-Related Disorders All trials for Mental Disorder All trials of Siyakhana CHW Training

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Treatment As Usual (TAU)No interventionMonitoring of treatment as usual (i.e., routine interactions between community health workers (CHWs) and their patients).
Siyakhana CHW TrainingExperimentalBehavioral: Siyakhana CHW TrainingThe 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.
  • Siyakhana CHW Training (Behavioral), also known as Siyakhana, Siyakhana - C: Please see arm description.

+Outcome measures

Primary outcomes

  • CHW Stigma Towards Substance Use [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 Stigma Towards Depression [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 [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 [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) 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.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Posted results

Participant flow

MilestoneSequence 1: Approximately 1 Month Treatment as Usual, Siyakhana CHW TrainingSequence 2: Approximately 2 Months Treatment as Usual, Siyakhana CHW TrainingSequence 3: Approximately 3 Months Treatment as Usual, Siyakhana CHW Training
Started292528
Completed262324
Not completed324

Outcome results

  • CHW Stigma Towards Substance Use (Primary), Mean, change in units on a scale: Siyakhana CHW Training -0.88 +/- 0.39
  • CHW Stigma Towards Depression (Primary), Mean, change in units on a scale: Siyakhana CHW Training 0.15 +/- 0.73
  • Training Feasibility (Primary), Count of participants, Participants: Sequence 1: Approximately 1 Month Treatment as Usual, Siyakhana CHW Training 26; Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training 25; Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training 27
  • Acceptability (Primary), Mean, units on a scale: Sequence 1: Approximately 1 Month TAU, Siyakhana CHW Training 2.92 +/- 0.29; Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training 2.84 +/- 0.26; Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training 2.80 +/- 0.24
  • CHW Training Fidelity (Primary), Mean, % of components delivered competently: Sequence 1: Approximately 1 Month TAU, Siyakhana CHW Training 86.7 +/- 8.2; Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training 85.7 +/- 11.8; Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training 82.7 +/- 10.1
  • CHW Stigma Towards Substance Use (Secondary), Mean, change in units on a scale: Siyakhana CHW Training -1.22 +/- 0.35
  • CHW Stigma Towards Depression (Secondary), Mean, change in units on a scale: Siyakhana CHW Training 0.51 +/- 1.17

Adverse events

Time frame: 6 months

ArmDeathsSerious adverse eventsOther adverse events
Sequence 1: Approximately 1 Month TAU, Siyakhana CHW Training0/29 (0.0%)0/29 (0.0%)0/29 (0.0%)
Sequence 2: Approximately 2 Months TAU, Siyakhana CHW Training0/25 (0.0%)0/25 (0.0%)0/25 (0.0%)
Sequence 3: Approximately 3 Months TAU, Siyakhana CHW Training0/28 (0.0%)0/28 (0.0%)0/28 (0.0%)

+Locations (1)

FacilityCityCountryStatus
South African Medical Research CouncilCape Town, Western CapeSouth Africa

+Publications

  • Results publication: Magidson JF, Regenauer KS, Johnson K, Ma T, Belus JM, Rose AL, Brown I, Ciya N, Ndamase S, Sacko C, Joska J, Sibeko G, Bassett IV, Myers B. Siyakhana: A hybrid type 2 effectiveness-implementation stepped-wedge trial to reduce stigma towards substance use and depression among community health workers in HIV/TB care in South Africa. J Subst Use Addict Treat. 2025 Apr;171:209634. doi: 10.1016/j.josat.2025.209634. Epub 2025 Jan 31. PMID 39892671
  • Results publication: Myers B, Regenauer KS, Rose A, Johnson K, Ndamase S, Ciya N, Brown I, Joska J, Bassett IV, Belus JM, Ma TC, Sibeko G, Magidson JF. Community health worker training to reduce mental health and substance use stigma towards patients who have disengaged from HIV/TB care in South Africa: protocol for a stepped wedge hybrid type II pilot implementation trial. Implement Sci Commun. 2024 Jan 2;5(1):1. doi: 10.1186/s43058-023-00537-w. PMID 38167261

+Study documents

+Investigators

+Funding

NIH grants: R34MH122268