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Набор скоро начнётся NCT07053514

Same-Day Antiretroviral Therapy as a Behavioral Design Intervention to Reduce Stigma in Key Affected Populations

Без фазы С лечением Hiv

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: SD-ART.
Кому может быть актуально
Состояния в реестре: Hiv. 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
Перу
Следующий шаг
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Обзор

The goal of this study is to develop and implement a same-day ART (SD-ART) protocol for key affected populations with HIV in Peru. The development of the protocol will be guided by asynchronous online focus groups with HIV experts to define eligibility criteria and essential components of the protocol, as well as nominal group technique focus groups and in-depth interviews to identify barriers and facilitators to SD-ART implementation. Finally, investigators will pilot the SD-ART protocol with patients and clinicians using a prospective, longitudinal design integrated into routine HIV care.

Подробное описание

The proposed study has 3 aims:

1. Conduct asynchronous online focus groups (AOFGs) and flowcharting to map the current ART initiation process and design a streamlined same-day antiretroviral therapy (SD-ART) protocol as a behavioral design. 2. Assess the multi-level barriers and facilitators to refine and implement an SD-ART protocol from the perspectives of patients, clinicians, and administrators, considering the high levels of stigma and suboptimal HIV treatment outcomes. Findings from Aims 1 and 2 will guide Aim 3. 3. Pilot-test the protocol-concordant SD-ART strategy in newly diagnosed People with HIV where investigators will assess and follow multi-level stigma constructs in patients and providers, analyzed through longitudinal dyadic analyses, to provide the evidence for SD-ART as a behavioral design intervention that reduces stigma.

The focus of this registration is the trial in aim 3.

Вмешательства

  • Поведенческое SD-ART
    SD-ART protocol for PWH with both patients and their HIV clinicians

Первичные конечные точки

  • Reductions in patient HIV and multi-dimensional stigma [Срок оценки: baseline, month 1, month 3, month 6, month 9, and month 12]
  • Provider stigma toward patients [Срок оценки: baseline, month 1, month 3, month 6, month 9, and month 12]
  • Everyday Discrimination Scale [Срок оценки: baseline, month 1, month 3, month 6, month 9, and month 12]

Критерии участия

Критерии включения

  • Aim 1:

HIV experts will be selected from National Societies of HIV experts according to the following criteria: 1) 18 years old or older; 2) Be an HIV expert, including those from NGOs providing HIV care, and international specialists; 3) Provide informed consent.

  • Aim 2:
  • NGT Focus Groups (FG)
  • Staff members
  • 18 years old or older.
  • Be a clinical staff member at Hospital Dos de Mayo or Patrucco Primary Health Center.
  • Provide informed consent.
  • PWH receiving HIV care
  • 18 years old or older.
  • Identify as member of a KAP.
  • Receive HIV care at Hospital Dos de Mayo or Patrucco Primary Health.
  • Provide informed consent.
  • PWH who dropped out of HIV care
  • 18 years old or older.
  • Identify as a member of a KAP.
  • Previously received HIV care at Hospital Dos de Mayo or Patrucco Primary Health but dropped out of care, as identified through patient registries.
  • Provide informed consent.
  • In-depth interviews
  • 1\) 18 years old or older.
  • 2\) Be the director of Hospital Dos de Mayo or Patrucco primary health center or the HIV director at the Ministry of Health
  • 3\) Provide informed consent
  • Aim 3:
  • Clinical Staff Dyadic Surveys
  • 1\) 18 years old or older.
  • 2\) Be an HIV provider at Hospital Dos de Mayo or Raul Patrucco Primary Health Center.
  • 3\) Provide HIV care to one of the 125 PWH
  • 4\) Provide informed consent.
  • Patient Dyadic Surveys
  • 1\) 18 years old or older.
  • 2\) Identify as a member of a KAP.
  • 3\) Be newly diagnosed with HIV and eligible for SD-ART based on clinical criteria identified from Aims 1 and 2.
  • 4\) Provide informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Перу · 2 центра
  • Centro de Salud Raul Patrucco Puig — Lima
  • Hospital Dos de Mayo — Lima

Идентификаторы

NCT: NCT07053514 · 2000040491 · R01TW013180

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗