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Идёт набор NCT06829394

Transitional Housing and HIV Health

Наблюдательное HIV HIV Antiretroviral Therapy (ART) Adherence Housing Instability

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: Program Assignment.
Кому может быть актуально
Состояния в реестре: HIV, HIV Antiretroviral Therapy (ART) Adherence, Housing Instability. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Type 1 Hybrid Effectiveness-Implementation Evaluation of a City-Level Transitional Housing Program's Effects on Health, Economic, and Psychologic Outcomes Among People With HIV

Обзор

The goal of this pilot study is to evaluate the implementation and outcomes of the Arms Around You (AAY) program, a supportive housing initiative launched by the Philadelphia Department of Public Health (PDPH) in 2024. The program aims to address housing instability among people with HIV (PWH) using a Housing First model. The main questions it seeks to answer are: 1. How does AAY affect HIV-related outcomes, particularly viral suppression and antiretroviral therapy (ART) adherence? 2. What are the program's effects on economic, psychological, and secondary health outcomes? 3. How feasible, acceptable, and scalable is the program for broader implementation? Participants will be assigned to immediate program access or a waitlist using a random lottery system, creating treatment and control groups, respectively. Surveys and health data will be collected at baseline and over 36 months to assess changes in outcomes such as viral suppression, housing security, mental health, and financial well-being. Qualitative interviews with participants and stakeholders will complement quantitative findings to explore mechanisms of change and guide program optimization.

Подробное описание

Housing instability significantly impedes HIV-related outcomes, such as engagement in care, ART adherence, and viral suppression. Structural racism and poverty exacerbate these disparities, particularly for racial and sexual minorities. To address this, the PDPH developed the AAY program, which combines rent support (up to 48 months), housing medical case management (MCM), and intensive housing counseling, following client-centered, harm-reduction principles.

This hybrid type 1 effectiveness-implementation study will evaluate the effects of the AAY intervention on health, economic, and psychological outcomes. PWH experiencing homelessness or severe housing instability will be prioritized for the program. The lottery-based design will allow researchers to observe differences between those granted immediate program access and those on the waitlist (who will receive standard of care treatment and serve as the control group). The primary outcomes of interest are HIV viral suppression (defined as \<200 copies/mL) and ART adherence, measured via pharmacy refill data. Secondary outcomes include housing security, food security, financial stress, psychological distress, and health-related quality of life.

Researchers will use mixed methods to collect data over 36 months. Quantitative data will include pre- and post-program surveys, pharmacy refill records, and PDPH surveillance data. Qualitative data will be gathered through semi-structured interviews with key stakeholders, including program participants, waitlisted individuals, referral case managers, implementing case managers and housing MCMs, and city leaders. These interviews will explore the program's acceptability, implementation challenges, and pathways through which housing support influences HIV outcomes.

Approximately 200 participants will be enrolled in the survey study, with data collected at baseline and at 6, 12, 24, and 36 months. Key implementation outcomes, such as the program's reach, sustainment, and costs, will also be analyzed to inform scalability. This study will provide critical evidence on how housing interventions can reduce health inequities and improve HIV-related outcomes, offering actionable insights for policymakers and public health leaders in Philadelphia and beyond.

Вмешательства

  • Другое Program Assignment
    The intervention group will include People living with HIV who were assigned to the Arms Around You Program in the lottery.

Первичные конечные точки

  • HIV viral suppression - defined as HIV RNA < 200 copies/mL [Срок оценки: From lottery to 12 months after the lottery]
  • ART adherence [Срок оценки: During discrete 3-month periods up to 12 months after the lottery]
Вторичные конечные точки (12)
  • Engagement in HIV care [Срок оценки: From lottery to 12 months after the lottery]
  • Health Related Quality of Life [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • Alcohol use [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • Cigarette Dependence [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • Recent Substance Use [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • ED visits and reason for most recent visit [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • Hospitalizations [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • Out of pocket health costs [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • HIV Transmission risk behaviors [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • Housing security [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • Perceived Housing Quality [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]
  • Neighborhood safety scale [Срок оценки: 6, 12, 24 and 36 months after assignment to the lottery]

Критерии участия

Inclusion Criteria: Inclusion criteria for the Lottery Population will be all PWH in priority groups 1 or 2 included in the initial lottery for access to the AAY program.

Inclusion criteria for the Survey population is (1) eligible for the HIV transitional housing program (2) priority group 1 or 2 with anticipated inclusion in the initial lottery (3) no plans to leave Philadelphia in the next year (4) regular access to a telephone to be able to complete phone surveys (5) able to provide informed consent.

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Exclusion Criteria: Does not meet the above inclusion criteria.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • University of Pennsylvania — Philadelphia
  • University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT06829394 · 855009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗