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Идёт набор NCT06684613

Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics

Без фазы С лечением Sexual Risk Behavior for HIV-infection Reproductive Health

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: PrEP Decision Aid, Generic Information.
Кому может быть актуально
Состояния в реестре: Sexual Risk Behavior for HIV-infection, Reproductive Health. Базовые параметры: от 18 лет · Женщины.
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

Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics

Обзор

This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.

Подробное описание

The purpose of this study is to expand and enhance a PrEP decision aid to include the full array of available formulation options and then integrate its delivery into sexual and reproductive health settings during counseling visits, where PrEP can be provided to all women who are interested. Rooted in health implementation frameworks, this study evaluates health and implementation determinants simultaneously along: 1) innovation characteristics; 2) clinical encounter; 3) recipients; and 4) context.

In Aim 1, patients (n=15-20), clinicians (n=10), and staff (n=10) at sexual and reproductive health clinics across Greater New Haven, CT will be engaged for semi-structured interviews to expand and enhance an existing PrEP decision aid to include all available formulations and optimize its integration into sexual and reproductive health clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in sexual and reproductive health clinics.

In Aim 2 (a hybrid Type 2 effectiveness-implementation study), patients will be randomized (n=50) to receive either the PrEP decision aid or generic PrEP information prior to a clinician visit. In follow-up interviews immediately post-visit, and at Months 3 and 6, primary outcomes are clinical efficacy (PrEP initiation) and implementation (using Proctor definitions for feasibility, acceptability, penetration, and adoption) that are important for future planned scale-up.

Вмешательства

  • Устройство PrEP Decision Aid
    Patient-facing decision-aid on PrEP that will be enhanced to include various formulations of available PrEP. Can be integrated into sexual and reproductive health clinics as part of counseling.
  • Другое Generic Information
    Participants will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis" (available online free of charge through the CDC web site). The video will serve as a time- and attention- based control to the decision aid.

Первичные конечные точки

  • PrEP initiation (prescribing) [Срок оценки: 6 months]
  • Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy [Срок оценки: 6 months]
  • Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy) [Срок оценки: 6 months]
  • Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy) [Срок оценки: 6 months]
  • Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy) [Срок оценки: 6 months]
  • Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy) [Срок оценки: 6 months]
  • Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy) [Срок оценки: 6 months]
Вторичные конечные точки (6)
  • PrEP initiation (dispensing) [Срок оценки: 6 months]
  • PrEP initiation (first use) [Срок оценки: 6 months]
  • PrEP adherence [Срок оценки: 6 months]
  • PrEP adherence [Срок оценки: 6 months]
  • PrEP adherence [Срок оценки: 6 months]
  • PrEP persistence [Срок оценки: 6 months]

Критерии участия

Patients (inclusion):

  • Woman
  • Aged 18 years or older
  • Have a uterus
  • Do not have HIV (by self-report)
  • Not currently on PrEP
  • Comfortable conversing in English or Spanish
  • Able to participate in informed consent procedures

Patients (exclusion):

  • People who cannot become pregnant (i.e., have had a hysterectomy or tubal ligation)
  • People who wish to become pregnant (will not qualify for pregnancy prevention counseling)
  • Have a scheduled visit with a member of the investigative team (to minimize risk of potential ascertainment bias)
  • Participants of Aim 1 cannot participate in Aim 2.

Sexual and Reproductive Health clinicians will be included if they provide sexual and reproductive health patient care at any of the participating sites. Clinic staff will be included if they work at any of the participating sites and have patient-facing or non-patient-facing roles .

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 · 1 центр
  • Yale Clinical and Community Research — New Haven

Идентификаторы

NCT: NCT06684613 · 2000038555 · 1R34MH137756-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗