HIV-Mental Illness Stigma Reduction and Outcomes in Malawi

NCT06951542 | Enrolling By Invitation DMC

• 2 other identifiers: 8573367K01MH130226-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The overall aim of this study is to assess the acceptability, feasibility, fidelity, and effectiveness of a depression treatment intervention augmented with counseling to address stigma. Using a multiple-baseline design, 200 depressed adults living with HIV will be enrolled in the trial. Participant surveys and abstracted clinical data related to HIV and depression care will assess the effectiveness of the intervention.

Conditions

Depression - Major Depressive Disorder; HIV; Health Condition Stigma

Keywords

Malawi; Health Condition Stigma; Stigma; Measurement-based Care (MBC); Friendship Bench (FB) Therapy; Salima; Mulanje; Mental Illness Stigma; HIV Stigma; Stigma Reduction Counseling; Stigma Intervention; Multi-Level Stigma Reduction; HIV Care Engagement; HIV; Depression

Outcome Measures

Primary Outcomes (13)

• Feasibility of the HIV-Mental Illness Stigma Reduction Intervention

  The investigators will measure feasibility by conducting qualitative interviews (guided by Proctor's Outcomes for Implementation Research) with providers and counselors who deliver the stigma-reduction intervention. This interview will consist of 12 open-ended questions (with subparts) meant to elicit a response from providers about their perceived changes in their patients' attitudes/well-being, their personal comfort level with delivering the intervention and competency, their training satisfaction, their recommendations for improving the intervention, and their perceived barriers and facilitators to implementation of the intervention.

  Upon the completion of intervention delivery for all patients (assessed up to 6 months)

• Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention

  The investigators will conduct audio-recorded semi-structured qualitative interviews with patients enrolled in the study who initiated depression treatment during the implementation phase. The investigators will use interview guides (using guidance from Proctor's Outcomes for Implementation Research) to conduct qualitative interviews with patients. The interviews will consist of 11 open-ended questions (with subparts) which are designed to elicit a response from the patient about their perceived acceptability of the intervention. This includes how helpful patients believed the intervention was in improving their mental health and feelings of stigma, barriers and facilitators to engagement in the intervention, and perceived areas of improvement and harm of the intervention.

  After completion of all intervention sessions, an average of 6 months

• Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention

  The investigators will measure acceptability of the intervention through a quantitative questionnaire, the Client Satisfaction Questionnaire-8. Each of the 8 questions are scored from 1-4 with higher ratings indicating greater satisfaction with the intervention.

  After completion of each intervention session

• Provider Acceptability of the HIV-Mental Illness Stigma Reduction Intervention

  The investigators will use interview guides (using guidance from Proctor's Outcomes for Implementation Research) to conduct qualitative interviews with counselors and providers who deliver the stigma-reduction intervention to assess acceptability to providers. This interview will consist of 12 open-ended questions meant to elicit a response from providers about their perceived changes in their patients' attitudes/well-being, their personal comfort level with delivering the intervention and competency, their training satisfaction, their recommendations for improving the intervention, and their perceived barriers and facilitators to implementation of the intervention.

  Upon intervention delivery completion for all patients (assessed up to 6 months)

• Fidelity of the Content of the HIV-Mental Illness Stigma Reduction Intervention

  The investigators will monitor fidelity in the content of the intervention protocol by assessing the extent to which providers correctly deliver depression treatment and stigma-reduction intervention by reviewing audio-recorded intervention sessions with patients using a fidelity checklist.

  Through study completion, an average of 6 months

• Fidelity of the Coverage of the HIV-Mental Illness Stigma Reduction Intervention

  The investigators will monitor fidelity in the coverage of the intervention protocol using clinical and program data to measure the percentage of patients who receive the correct depression treatment and the stigma-reduction intervention.

  Through study completion, an average of 6 months

• Fidelity of the Frequency of the HIV-Mental Illness Stigma Reduction Intervention

  The investigators will monitor fidelity in the frequency of the intervention protocol using clinical and program data to measure the number of completed depression treatment appointments and stigma-reduction intervention sessions, as well as the number of patients who complete the depression treatment and stigma-reduction intervention.

  Through study completion, an average of 6 months

• Fidelity of the Duration of the HIV-Mental Illness Stigma Reduction Intervention

  The investigators will monitor fidelity in the duration of the intervention protocol using clinical and program data to measure the number of depression treatment and stigma-reduction intervention sessions patients receive over their first six months in HIV care and the attendance of at least 75% of scheduled depression treatment appointments and stigma-reduction intervention sessions (y/n) over the first six months in HIV care.

  Through study completion, an average of 6 months

• Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma

  Internalized AIDS-Related Stigma Scale will be used to assess patient's level of internalized HIV stigma. Patients rate their agreement of 6 statements. Items are scored with a 0 for disagree or 1 for agree. A higher total scores indicate greater internalized stigma.

  At enrollment, 3-months post enrollment, and 6-months post enrollment

• Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma

  The Adapted Internalized Stigma of Mental Illness Scale will be used to assess patient's level of internalized HIV stigma. The Adapted Internalized Stigma of Mental Illness Scale measures patient's internalized stigma with regard to their mental health. Patients rate their agreement with 29 statements across five subscales: alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance. The scale for scoring items indicates a 0 for "strongly disagree" to a 4 for "strongly agree". A higher total scores indicate greater internalized stigma.

  At enrollment, 3-months post enrollment, and 6-months post enrollment

• Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Address Depression

  The investigators will utilize the Patient Health Questionnaire (PHQ-9), completed by providers, to measure patients' severity of depression. Patients will indicate how often they experienced 9 depression symptoms in the last 2 weeks. The scale for scoring items indicates a 0 for "not at all" and a 3 for "nearly every day". Higher total scores indicate greater depression severity. Scores of 5 or more are indicative of mild to severe depression.

  At enrollment, 3-months post enrollment, and 6-months post enrollment

• Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Improve HIV Care Engagement

  Clinical data related to antiretroviral therapy appointment attendance will be abstracted.

  Through study completion, an average of 6 months

• Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Improve HIV Care Engagement

  Clinical data related to antiretroviral therapy pill counts will be abstracted.

  Through study completion, an average of 6 months

Study Arms (2)

Pre-Implementation Phase

NO INTERVENTION

In the pre-implementation phase, antiretroviral therapy (ART) providers will screen and treat patients at ART for depression as is now standard practice. Namely, patients will be screened using the Patient Health Questionnaire-9 (PHQ-9) and depressed patients will be treated with Measurement-based Care (MBC) and/or Friendship Bench (FB) problem-solving therapy. At each monthly ART appointment, providers assess patients' depressive symptoms and continue depression treatment as clinically indicated.

Intervention Implementation Phase

EXPERIMENTAL

In the intervention implementation phase, patients at antiretroviral therapy (ART) will be screened and treated for depression as described and assessed for the study enrollment as in the pre-implementation phase. Depressed patients will be referred to counselors to receive the stigma-reduction intervention sessions. Stigma-reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma. Intervention sessions will be audio-recorded (with participants' consent) as part of the fidelity assessment.

Behavioral: Stigma Reduction Counseling

Interventions

Stigma Reduction Counseling BEHAVIORAL

The stigma reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma.

Intervention Implementation Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living with HIV and receiving ART at Salima or Mulanje District Hospital
• Adult (18+ years)
• Elevated depressive symptoms (PHQ-9 Score ≥5)

You may not qualify if:

• Pregnant women
• Severe mental or physical illness

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Pennsylvania: lead

Study Sites (2)

Mulanje District Hospital

Mulanje, Malawi

Location

Salima District Hospital

Salima, Malawi

Location

MeSH Terms

Conditions

Social Stigma; Depression

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The investigators will conduct a pilot trial, with a multiple baseline design to enroll 200 depressed PLHIV at the study sites who will either receive usual depression care during the pre-implementation phase or enhance usual depression care (+ stigma-reduction counseling) during the implementation phase. Using the multiple baseline design with two phases (a pre-implementation phase and an intervention implementation phase), the intervention launches earlier at Clinic A than Clinic B, based on random selection. Staggering the launch of the implementation phase will allow for assessment of and potential correction for any secular trend in outcomes.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: April 30, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

MA (2)