Intervention Development for Syndemics Among PWH in SA

Официальное название

Developing and Piloting a Multilevel Intervention to Address Psychosocial and Structural Syndemics in People With HIV in South Africa

Обзор

In South Africa, the country with the highest HIV prevalence (19%), co-occurring problems such as depression, post-traumatic stress, and food insecurity interact to enhance one another (i.e., syndemic problems) and are associated with worse HIV outcomes such as worse antiretroviral therapy (ART) adherence and worse viral load. This study proposes to: 1) explore how syndemic problems work together to make health worse for people with HIV (PWH) and explore what people think about a potential treatment; 2) develop a treatment to address syndemic problems and improve ART adherence (CBT-SA); 3a) assess whether people are willing to receive the CBT-SA we it can actually be done; and 3b) identify factors that make it easier or more difficult to receive CBT-SA.

Подробное описание

South Africa (SA) has a generalized HIV epidemic, and the highest HIV prevalence rate (19%). Psychosocial (e.g., depression, post-traumatic stress) and structural problems (e.g., food insecurity) are associated with worse antiretroviral therapy (ART) adherence and higher viral load. Depression, post-traumatic stress, and food insecurity are also highly comorbid and are thought to interact synergistically to confer greater risk for worse HIV outcomes (i.e., syndemic problems). The proposed specific aims are to: 1) explore the complex interrelationships between food insecurity, depression, and post-traumatic stress, as they relate to engagement in HIV care, and explore attitudes to potential intervention components; 2) develop a multilevel intervention to address syndemic problems and improve adherence (CBT-SA) and conduct an iterative proof-of-concept pilot trial use syndemic theory; 3a) assess the feasibility and acceptability of CBT-SA in a pilot RCT; and 3b) identify barriers and facilitators of CBT-SA engagement among PWH and uptake among care providers and other key local partners to inform a future hybrid effectiveness/implementation R01 trial. If successful, this intervention would be further tested for effectiveness and implementation in a future application.

Вмешательства

• Поведенческое Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)
  We anticipate the intervention will contain the following: CBT for depression and trauma, Life-Steps for ART adherence, nutritional counseling, supplementary food parcels, case management, linkage to care. Specific intervention components will be informed by prior aims.

Первичные конечные точки

• 75% of participants randomized to CBT-SA attend at least 66% of the sessions [Срок оценки: 6-month follow-up]
• 75% of the participants randomized to CBT-SA attend the 6-month follow-up visit. [Срок оценки: 6-month follow-up]

Вторичные конечные точки (3)

• ART adherence [Срок оценки: 6-month follow-up]
• Presence of depression measured by the DIAMOND diagnostic instrument [Срок оценки: 6-month follow-up]
• Presence of PTSD measured by the DIAMOND diagnostic instrument [Срок оценки: 6-month follow-up]

Критерии участия

Критерии включения

• Patient receiving HIV care in Khayelitsha (confirmed by medical record)
• Currently prescribed TDF-based ART, with recent difficulties with ART adherence (self-reported in past 30 days / confirmed by pharmacy refill data)
• Mild, moderate, or severe food insecurity (measured by HFIAS categories) AND ≥1 of the following:

• Clinically significant depressive symptoms (CES-D ≥ 16)
• Clinically significant post-traumatic stress symptoms (SPAN ≥ 5)
• 18 years of age or older

Критерии исключения

• Unable or unwilling to provide informed consent
• In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling
• Current untreated or undertreated serious mental health issue that would interfere with participation

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

Простое слепое

Основная цель

Лечение

Центры проведения

ЮАР · 1 центр

• University of Cape Town — Cape Town

Идентификаторы

NCT: NCT06152003 · 2023P002344

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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