HIV-Mental Illness Stigma Reduction and Outcomes in Malawi

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

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

Критерии исключения

• Pregnant women
• Severe mental or physical illness

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Malawi · 2 центра

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

Идентификаторы

NCT: NCT06951542 · 857336 · 7K01MH130226-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗