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Идёт набор NCT05736614

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

Без фазы С лечением Prevention

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: Stage 1 Strength Based Case Management (SBCM) Condition, Stage 2 PrEPare for Work Intervention Condition.
Кому может быть актуально
Состояния в реестре: Prevention. 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
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

Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design

Обзор

"PrEPare for Work" is a randomized controlled trial (RCT) whose goal is to test the efficacy of a behavioral intervention (Short Title: PrEPare for Work) in improving PrEP uptake, adherence, and persistence among male sex workers (MSW)

Подробное описание

A theory-based, manualized intervention -called "PrEPare for Work"-includes two separate but complementary interventions that address MSW-specific behavioral, economic, interpersonal \& structural-level barriers to accessing and adhering to PrEP: 1) peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake; and 2) a technology and counseling intervention to optimize PrEP adherence (once they have access to PrEP). This research will test the PrEPare for Work intervention in a fully-powered RCT to assess efficacy and cost-effectiveness.

Вмешательства

  • Поведенческое Stage 1 Strength Based Case Management (SBCM) Condition
    Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.
  • Поведенческое Stage 2 PrEPare for Work Intervention Condition
    Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.

Первичные конечные точки

  • Stage one: PrEP initiation [Срок оценки: 2-month post Stage 1 randomization]
  • Stage two: PrEP adherence [Срок оценки: 12-month post Stage 2 randomization]
Вторичные конечные точки (1)
  • PrEP persistence [Срок оценки: 12-month post Stage 2 randomization]

Критерии участия

Inclusion

  • Age: 18 years or older
  • Assigned male sex at birth
  • Identifies as male at enrollment
  • Report having engaged in condomless anal sex with another man in the past 3 months
  • Report having exchanged sex for money, drugs, items of value, or a place to stay with another man in the past 3 months
  • Report HIV status as negative or unsure
  • Not currently on PrEP
  • Able to understand and speak English or Spanish

Exclusion

  • Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview (will use an adapted version of the Evaluation to Sign Consent Form65 to assess capacity)
  • Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment)
  • Laboratory or clinical findings that would preclude PrEP initiation (e.g. Chronic Hepatitis B Virus infection, decreased creatinine clearance)
  • Participated in the pilot RCT and initiated PrEP during study participation

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 5 центров
  • UCLA Fielding School of Public Health — Los Angeles
  • The Miriam Hospital — Providence
  • Open Door Health — Providence
  • Project Weber/RENEW — Providence
  • Brown University School of Public Health — Providence

Публикации

  • Biello KB, Chan PA, Ndoye CD, Nelson L, Nelson E, Silva V, Kwak E, Napoleon S, Cormack Orellana C, Richards OG, Davis E, Mimiaga MJ. Study protocol of a randomized controlled trial to assess the efficacy of the "PrEPare for Work" intervention to enhance PrEP uptake and optimize adherence for HIV prevention among male sex workers in the U.S. BMC Public Health. 2024 Feb 9;24(1):424. doi: 10.1186/s12 PMID 38336731

Идентификаторы

NCT: NCT05736614 · 2001002627 · R01NR020227

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗