HIV-Mental Illness Stigma Reduction and Outcomes in Malawi

Official title

Improving HIV and Depression Outcomes by Reducing HIV-Mental Illness Stigma in Salima and Mulanje Districts: Pilot Trial

Overview

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Feasibility of the HIV-Mental Illness Stigma Reduction Intervention [Time frame: Upon the completion of intervention delivery for all patients (assessed up to 6 months)]
• Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention [Time frame: After completion of all intervention sessions, an average of 6 months]
• Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention [Time frame: After completion of each intervention session]
• Provider Acceptability of the HIV-Mental Illness Stigma Reduction Intervention [Time frame: Upon intervention delivery completion for all patients (assessed up to 6 months)]
• Fidelity of the Content of the HIV-Mental Illness Stigma Reduction Intervention [Time frame: Through study completion, an average of 6 months]
• Fidelity of the Coverage of the HIV-Mental Illness Stigma Reduction Intervention [Time frame: Through study completion, an average of 6 months]
• Fidelity of the Frequency of the HIV-Mental Illness Stigma Reduction Intervention [Time frame: Through study completion, an average of 6 months]
• Fidelity of the Duration of the HIV-Mental Illness Stigma Reduction Intervention [Time frame: Through study completion, an average of 6 months]
• Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma [Time frame: At enrollment, 3-months post enrollment, and 6-months post enrollment]
• Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma [Time frame: At enrollment, 3-months post enrollment, and 6-months post enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Malawi · 2 centers

• Mulanje District Hospital — Mulanje
• Salima District Hospital — Salima

Identifiers

NCT: NCT06951542 · 857336 · 7K01MH130226-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗