Adaptation and Evaluation of an Intersectional Stigma Reduction Intervention to Increase HIV Care Engagement Among Women Who Use Drugs

Обзор

The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care.

Подробное описание

This study will evaluate the feasibility, acceptability, and preliminary efficacy of a behavioral intervention designed to reduce intersectional HIV- and drug use-related stigma and improve HIV care engagement among women living with HIV who use drugs in Ukraine. A total of 100 eligible women will be randomized to either the intervention or a control condition. Participants in both groups will receive standard HIV care and a one-time consultation with a social worker, complete baseline, 3-month, and 6-month assessments, and have HIV care outcomes assessed. Participants assigned to the intervention will additionally attend five small-group sessions focused on stigma coping, cognitive-behavioral skills, communication, social support, and HIV care engagement, with an optional individual session involving a support person. The study will examine effects on HIV care engagement, antiretroviral therapy adherence, and stigma-related psychosocial outcomes to inform a future fully powered randomized controlled trial.

Вмешательства

• Поведенческое Light Inside
  Adapted intersectional stigma reduction intervention consisting of five facilitator-led, small-group sessions delivered over approximately 2-3 weeks. The intervention uses cognitive-behavioral strategies to reduce HIV- and drug use-related stigma by strengthening adaptive coping, cognitive restructuring, communication skills, social support, and HIV care self-efficacy to improve HIV care engagement and antiretroviral therapy adherence. Participants may also complete an optional individual sessio
• Поведенческое standard of care
  Standard of Care: Participants will continue to receive standard HIV and substance use care available through their usual healthcare providers. In addition, they will receive a one-time consultation with a social worker, delivered either in person or remotely, to provide support and linkage to available services.

Первичные конечные точки

• HIV care engagement as assessed by the Number of participants who re-engage in HIV care [Срок оценки: 6 months]
• Antiretroviral therapy (ART) adherence as assessed by the percentage of days covered by dispensed antiretroviral medication [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Female; Age 18 years or older;
• Registered in the national Medical Information System (MIS) as having received an HIV-positive diagnosis;
• Registered in the MIS with injection drug use (IDU) as the probable mode of HIV transmission or with a documented history of injection drug use at any clinical visit.

Критерии исключения

• Does not meet the inclusion criteria;
• Unable to provide informed consent;
• Unable to provide informed consent due to intoxication, the effects of drug use, or severe psychiatric impairment at the time of consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07751978 · IRB00029819 · 5R01TW012908

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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