HIV-Mental Illness Stigma Reduction and Outcomes in Malawi

NCT ID: NCT06951542

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2027-04-30

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.

Detailed Description

Stigma and depression are associated with increased HIV-related mortality and morbidity; as depression treatment is increasingly integrated into HIV care, addressing HIV stigma, mental illness stigma, and intersectional HIV-mental illness stigma is crucial. The Malawi Ministry of Health has recently integrated depression screening and treatment into the antiretroviral therapy (ART) departments of 12 District Hospitals across the country, including Salima and Mulanje District Hospital. Through this program, adults living with HIV are now screened with the Patient Health Questionnaire-9 (PHQ-9) and depressed patients are prescribed antidepressants using Measurement-based Care (MBC) or referred for Friendship Bench (FB) problem-solving therapy.

With this study the investigators aim to augment the existing depression treatment program at Salima and Mulanje District Hospitals with counselling to help address and reduce stigma. The stigma reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma. Ultimately, this study will evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the HIV-mental illness stigma-reduction intervention as part of depression treatment integrated into HIV care at Salima and Mulanje district hospitals using a pilot trial, with a multiple-baseline design. To achieve this goal, the investigators will enroll 200 depressed adults living with HIV in the trial, survey patient participants at enrollment, 3-months and 6-months, abstract clinical data related to HIV and depression care, track engagement in the stigma reduction intervention, assess intervention sessions for fidelity to the intervention protocol and conduct qualitative interviews with a sub-set of patients who received the stigma-reduction intervention (n=20) and healthcare providers including HTC counselors (N=4), ART providers (N=10), Friendship Bench counselors (N=6), and counselors (n=4) who deliver the stigma-reduction intervention.

This innovative research will a) address HIV, MI and intersectional stigma while leveraging existing mental health services for people living with HIV, b) lay the ground-work for a multi-level stigma-reduction intervention package, and c) yield detailed insights into barriers and facilitators of implementing stigma-reduction interventions in low-resource settings.

Conditions

Depression - Major Depressive Disorder; HIV; Health Condition Stigma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-Implementation Phase

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Implementation Phase

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.

Group Type: EXPERIMENTAL

Stigma Reduction Counseling

Intervention Type: 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.

Interventions

Stigma Reduction Counseling

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnant women
• Severe mental or physical illness

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Melissa Stockton

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mulanje District Hospital

Mulanje, , Malawi

Salima District Hospital

Salima, , Malawi

Countries

Malawi

Other Identifiers

7K01MH130226-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

857336

Identifier Type: -

Identifier Source: org_study_id