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Набор скоро начнётся NCT07459218

IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania

Без фазы С лечением HIV - Human Immunodeficiency Virus Suicide 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: IDEAS for Hope, Safety Planning Intervention.
Кому может быть актуально
Состояния в реестре: HIV - Human Immunodeficiency Virus, Suicide Prevention. 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
Tanzania
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

IDEAS for Hope: A Brief Telehealth Intervention to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania

Обзор

In this project, the investigators will conduct a clinical trial to test the effectiveness and implementation of IDEAS for Hope, a 3-session telehealth counseling intervention delivered by nurses, to reduce suicidality and improve HIV care engagement among PLWH in Tanzania. The investigators will also examine mechanisms of change and implementation outcomes of the intervention, including cost-effectiveness, to disseminate a feasible, scalable, and sustainable intervention and implementation package to address a critical mental health comorbidity in HIV care.

Подробное описание

Suicide is a leading cause of death among people living with HIV (PLWH) worldwide and PLWH in Tanzania are two to three times as likely to die by suicide compared to people without HIV. Mental health challenges are also closely linked to poor HIV outcomes, including lapses in clinic attendance, poor medication adherence, risk of HIV transmission, and AIDS-related death. Yet when PLWH receive mental health treatment that addresses barriers to HIV treatment adherence, both mental health and HIV outcomes improve. The investigators are developing innovative approaches to bridge the mental health treatment gap in Tanzania, including telehealth and nurse-led counseling interventions. The investigators previously developed and conducted a pilot feasibility randomized controlled trial of IDEAS for Hope, a 3-session telehealth counseling intervention, led by nurses, to reduce suicide risk and improve HIV care engagement in Tanzania. The IDEAS for Hope intervention, grounded in Motivational Interviewing, CBT, and Problem-Solving Therapy frameworks, facilitates HIV education, stigma reduction, and social support to address social determinants of suicide risk. The pilot trial with 60 PLWH who were experiencing suicidal ideation demonstrated clear feasibility and acceptability of IDEAS for Hope, as well as strong trends toward intervention efficacy to reduce suicide risk. The long-term objective of this research is to develop a scalable implementation package to expand care, reduce suicide risk, and improve HIV care engagement in Tanzania. In Aim 1, the investigators will determine the effectiveness of IDEAS for Hope to reduce suicide risk and improve HIV care engagement in an individually randomized controlled trial. Based on the pilot trial, the investigators hypothesize that IDEAS for Hope will reduce suicidal plan and intent to near zero and will improve HIV care engagement by 17% at 6-month follow-up, which will be statistically superior to brief safety planning. In Aim 2, the investigators will explore mechanisms of change to identify how and for whom IDEAS for Hope is most effective. The investigators will analyze the effect of hypothesized mediators of suicide risk and HIV care engagement, including self-efficacy, depression, anxiety, and stigma; potential moderators include sex, age, and severity of baseline symptoms. These data will inform future refinement for at-risk groups and adaptation to other settings. In Aim 3, the investigators will evaluate implementation outcomes, including cost-effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). The investigators hypothesize that IDEAS for Hope will be effectively expanded to 12 clinic sites, with a favorable Incremental Cost-Effectiveness Ratio. Structured surveys and qualitative interviews with patients and providers will assess fidelity and sustainability outcomes for implementation. Given the emerging evidence for telehealth and nurse-led approaches, IDEAS for Hope has great potential to reduce the mental health treatment gap in Tanzania. The research is innovative, yet fundamentally essential, and supports NIH Strategic Objectives to prevent suicide across the lifespan in low- and middle-income countries, address mental health comorbidities of HIV, and strengthen the HIV care continuum.

Вмешательства

  • Поведенческое IDEAS for Hope
    The IDEAS for Hope framework integrates Joiner's Interpersonal Theory to address stigma, burdensomeness, and other drivers of suicide risk and improve HIV care engagement. This includes theoretical grounding in Motivational Interviewing-enhanced safety planning (MI-SafeCope), stigma reduction, cognitive-behavioral therapy with adherence counseling (CBT-AD), and problem-solving therapy. MI-SafeCope improves coping for suicide risk by developing an individualized safety plan and facilitating socia
  • Поведенческое Safety Planning Intervention
    The single-session safety planning intervention (SPI) will be provided according to protocols developed by Stanley \& Brown. The SPI involves collaboratively creating a personalized, step-by-step plan to help individuals recognize warning signs, use coping strategies, seek support, and reduce access to means during a suicidal crisis.

Первичные конечные точки

  • Number of participants with Suicidal thinking [Срок оценки: 6 months]
  • Number of participants with a Suicidal plan [Срок оценки: 6 months]
  • Number of participants with Suicidal intent [Срок оценки: 6 months]
  • Number of participants with Suicide preparatory behavior [Срок оценки: 6 months]
  • Number of participants with Suicide attempt [Срок оценки: 6 months]
  • Number of participants with HIV care engagement [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Adult
  • Living with HIV
  • Attending HIV care appointments
  • Self-report experiencing thoughts of suicide in the last 30 days

Критерии исключения

  • Physically or cognitively unable to provide informed consent or complete study procedures

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Tanzania · 1 центр
  • Kilimanjaro Clinical Research Institute — Moshi

Идентификаторы

NCT: NCT07459218 · Pro00119742

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗