A Trauma-Informed Intervention for the Newly HIV-Diagnosed
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Resilience-Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE), Waitlist control: Text messaging-reminder comparison condition.
- Кому может быть актуально
- Состояния в реестре: Stress, HIV Care Loss to Followup, HIV Treatment Cascade. Базовые параметры: от 18 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Trauma-Informed Intervention for Sexual Minority Men Recently Diagnosed With HIV
Обзор
The current approach to HIV prevention emphasizes: (1) achieving viral suppression among HIV+ people in order to reduce HIV transmissibility, particularly for disproportionately affected groups such as Black sexual minority men (BSMM), by increasing retention in HIV care, and (2) addressing comorbidities and complications, which include mental health concerns such as trauma symptomology and severe acute stress reactivity. Despite the disproportionate impact of both HIV and traumatic stress on BSMM and the adverse effects of stress on engagement in HIV care, BSMM remain grossly underserved with respect to mental health. To address these gaps, the proposed study will develop an intervention that will: (1) provide a brief, resilience-oriented, trauma-informed intervention that combines online sessions and highly tailored text-messaging to reduce participant burden and motivate clients between sessions, (2) provide preliminary treatment for HIV+ BSMM's unaddressed mental health needs, and (3) be embedded early in the HIV continuum of care immediately after diagnosis to facilitate linkage to and retention in HIV care.
Подробное описание
Compared to the general population in the United States, people living with HIV (PLWH) show high rates of trauma- and stress-related disorders and severe acute stress reactivity to events that are, diagnostically, not considered traumatic. Trauma is highly correlated with depression, a robust predictor of antiretroviral treatment (ART) non-adherence. Additionally, reporting a high number of recent stressful events is associated with ART non-adherence. Despite Black sexual minority men (BSMM), particularly those under age 40, being disproportionately affect by HIV and trauma and less likely to be linked to HIV care after diagnosis, BSMM remain grossly underserved with respect to mental health. Further, although interventions exist that address trauma for PWLH, few HIV-related interventions emphasize the traumatic stress cycle and acute stress reactivity immediately following an HIV diagnosis. To address the need for early mental health intervention immediately after HIV diagnosis, in general, as well as the under-addressed mental-health needs of HIV+ BSMM (+BSMM), in particular, the investigators will develop and pilot-test a resilience-focused, trauma-informed intervention called, Resilience- Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE). RISE will be based on approaches and techniques of Cognitive-Behavior Therapy (CBT) and the framework of Resilience Theory. It will address trauma- and stress-related symptomology and acute stress reactivity within three months of an HIV diagnosis to facilitate linkage to HIV care. The brief RISE will include six online sessions, a booster session, and text messaging. Innovative commercial marketing techniques will be used to develop highly targeted messages to supplement the CBT- and resilience-based approach of RISE. First, Aim 1 will involve formative research to assess +BSSM's needs, preferences, and perceptions regarding mental health and engagement in HIV care via in-depth interviews with +BSMM and service providers. Next, Aim 2 will include development of the RISE intervention manual and digital health infrastructure. Tailored text messages and health-promotion materials will be developed via in-depth interview-derived quantitative surveys with 50 +BSMM. The Aim will also include an iterative process of intervention development, including focus groups with +BSMM and service providers, respectively, and intervention theatre tests with 6 +BSMM. Finally, Aim 3 will consist of a randomized, controlled pilot trial for feasibility (e.g., recruitment and enrollment rates, fidelity), acceptability (i.e., feedback interview, satisfaction questionnaire), and preliminary efficacy (i.e., increased HIV care engagement, including attending an HIV care appointment, antiretroviral treatment ART initiation, and ART adherence primary outcome; reduced trauma symptoms, including intrusive experiences, avoidance, and hyperarousal secondary outcome) with 40 +BSMM diagnosed within the past three months. Participants will be assessed at baseline, post-intervention, and 6- and 9-month follow-ups post-baseline. The investigators will develop and maintain a community advisory board for consultation throughout the study.
Вмешательства
- Поведенческое Resilience-Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE)
RISE is based on Cognitive-Behavior Therapy (CBT) and the Information-Motivation-Behavioral Skills (IMB) Model. RISE will consist of six, weekly sessions, followed by a booster session in week 8, including resilience-building and health-promoting activities of RISE. Sessions will emphasize the participants' strengths, including positive thoughts, beliefs, and behaviors that work for the client and existing assets and supports in the participant's life. Tailored, health-promotion text messages wi - Поведенческое Waitlist control: Text messaging-reminder comparison condition
This control condition will involve reminder text messages for adherence to HIV treatment and engaging in HIV care. As this condition is a waitlist control, participants in this condition will ultimately receive the RISE intervention.
Первичные конечные точки
- Client Satisfaction Questionnaire-8 [Срок оценки: Throughout study completion: 3-, 6- and 9-Month Follow-Up Post-Baseline]
Вторичные конечные точки (12)
- Question (Yes/No; Attended HIV care appointment in past 3 months): "Have [the participant] attended an HIV care appointment with a HIV care, primary care, or similarly care provider in the past 3 months?" [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Question (Yes/No; Initiated antiretroviral treatment): "Have [the participant] begun taking medication prescribed to treat HIV?" [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Question (Yes/No; Have future appointment scheduled): "Do [the participant] have a future HIV care appointment scheduled?" [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up]
- Visual Analog Scale [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Berlin Social Support Scale [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Impact of Event Scale - Revised [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Center for Epidemiologic Studies - Depression Scale [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Beck Depression Inventory-II [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Coping Self-Efficacy Scale [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Illness Intrusiveness Ratings Scale [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- HIV Treatment Adherence Self-Efficacy Scale [Срок оценки: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Demographics [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Diagnosed with HIV within the past 3 months
- Self-identification as Black or African American
- Aged 18-39 years
- Elevated traumatic stress as indicated by scores above clinical cutoffs on either of the following subscales of the Impact of Event Scale--Revised: Intrusion (score of 5 or greater) and Avoidance (score of 7 or greater)
- Owning a phone with short-message service or messaging
- Access to a device with a screen, a web browser, and adequate internet speed for videoconferencing (e.g., smartphone, computer).
Критерии исключения
- Demonstrating cognitive impairment or acute psychosis
- Reporting unvailability to participate in the Baseline Assessment, the RISE intervention, and 3-, 6, and 9-Month Follow-Up Assessments
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
- Профилактика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07055360 · R34MH132561 · 1R34MH132561-01