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Набор скоро начнётся NCT07225062

Improving HIV Prevention and Substance Use Post-Sexual Assault Services

Без фазы С лечением HIV Infections Substance Use Sexual Assault

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: Enhanced intervention, Usual Care.
Кому может быть актуально
Состояния в реестре: HIV Infections, Substance Use, Sexual Assault. Базовые параметры: 17 лет — 25 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 →

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Официальное название

Improving HIV Prevention and Substance Use Post-Sexual Assault Services for Adolescents and Young Adults

Обзор

The purpose of this study is to tailor existing sexual assault nurse examiner (SANE) services with same-day HIV prophylaxis and substance use screening, brief intervention, or referral using semi-structured adolescents and young adults (AYA) survivor and key informant interviews, and iterative co-design/pilot testing of adapted strategies with the youth working group (YWG), to optimize study mechanisms and outcome measures using cognitive interviews, analysis of community partner data, and recruitment and retention strategies with the youth working group (YWG) and community advisory board (CAB), to conduct a pilot randomized controlled trial with 40 AYA to test feasibility, acceptability, and initial efficacy compared to usual care, to evaluate recruitment, randomization, and follow-up strategies; adherence to intervention dose; retention benchmarks; and acceptability and to evaluate preliminary efficacy of outcome measures (uptake of post-assault HIV prevention and substance use treatment).

Вмешательства

  • Поведенческое Enhanced intervention
    The intervention has three components: 1). Exploring how to increase access to and promotion of SANE services among vulnerable AYA within the 72 hr window for nPEP treatment; 2). Enhanced SANE services to increase same-day access to nPEP and DoxyPEP and 3). An advocate-delivered screening, brief intervention, and referral to prevent and address substance misuse.
  • Поведенческое Usual Care
    The usual care condition will be used with control participants and entail receiving typical SANE services without modifications to enhance HIV prevention or substance use screening, brief intervention, or referral to treatment

Первичные конечные точки

  • Recruitment feasibility as measured by percentage of eligible individuals screened [Срок оценки: end of study (1 month after baseline)]
  • Recruitment feasibility as measured by percentage of eligible individuals enrolled [Срок оценки: end of study (1 month after baseline)]
  • Recruitment feasibility as measured by time delay from screening to enrollment [Срок оценки: end of study (1 month after baseline)]
  • Recruitment feasibility as measured by time to enroll sufficient sample size [Срок оценки: end of study (1 month after baseline)]
  • Recruitment feasibility as measured by percentage loss to exclusion criteria. [Срок оценки: end of study (1 month after baseline)]
  • Randomization strategies as measured by proportion randomized to intervention and control [Срок оценки: end of study (1 month after baseline)]
  • Retention as measured by the number of participants that completed the one month follow-up survey [Срок оценки: end of study (1 month after baseline)]
  • Retention of the intervention group as measured by the number of participants that completed the one month follow-up survey [Срок оценки: end of study (1 month after baseline)]
  • Retention of the control group as measured by the number of participants that completed the one month follow-up survey [Срок оценки: end of study (1 month after baseline)]
  • Adherence to intervention as measured by percentage of content completed in the fidelity checklist [Срок оценки: end of study (1 month after baseline)]
Вторичные конечные точки (5)
  • Uptake of post-assault HIV prevention as measured by self report of nPEP uptake [Срок оценки: 1-month follow-up]
  • Uptake of substance use treatment as self reported as reported on the self report questionnaire [Срок оценки: 1-month follow-up]
  • Uptake of post-assault HIV prevention as measured by self report of Doxycycline Post-Exposure Prophylaxis (DoxyPEP) uptake [Срок оценки: 1-month follow-up]
  • Adherence of non-occupational Post-Exposure Prophylaxis (nPEP) as reported on the self report questionnaire [Срок оценки: 1-month follow-up]
  • Adherence of substance use treatment as reported on the self report questionnaire [Срок оценки: 1-month follow-up]

Критерии участия

Критерии включения

  • experienced a sexual assault within the last 72 hours
  • speak English
  • not planning to move out of the metro area during the study.

Критерии исключения

  • noticeably intoxicated or under the influence
  • are overtly having severe, untreated mental illness symptoms

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
Профилактика

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT07225062 · HSC-SN-25-0423

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗