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Идёт набор NCT07194902

HIV Self-testing for Partners of HIV-uninfected Postpartum Women

Без фазы С лечением HIV Self-testing Male Partners of HIV-negative Postpartum Women PrEP Uptake Feasibility

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: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P")..
Кому может быть актуально
Состояния в реестре: HIV Self-testing, Male Partners of HIV-negative Postpartum Women, PrEP Uptake, Feasibility. 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
ЮАР
Следующий шаг
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Официальное название

HIV Self-testing for Partners of HIV-uninfected Postpartum Women to Facilitate PrEP and Antiretroviral Therapy Uptake to Promote HIV Treatment and Prevention

Обзор

The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving. The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.

Вмешательства

  • Поведенческое HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").
    For female participants, the intervention includes a 30-45 minute counseling session that will cover (1) SOC PrEP information, (2) communications skills training for HIVST kit distribution, (3) Motivational interviewing strategies (e.g., PrEP/HIVST pros/cons), (4) problem-solving barriers to PrEP uptake or HIVST distribution, (5) linkage enablers (e.g., care sites, transportation, asking questions of providers). For their male partners, an informative video will cover geographically diverse HIV

Первичные конечные точки

  • Feasibility of intervention [Срок оценки: Baseline and 3-month follow-up]
  • Acceptability [Срок оценки: Post-Intervention]
  • Safety concerns as a result of HIVST distribution [Срок оценки: Baseline and 3-month follow-up]
  • Preliminary effectiveness of H4P intervention. [Срок оценки: 3-month follow-up]
  • Challenges, successes, barriers, facilitators, and preferences for optimizing H4P intervention. [Срок оценки: 3-month follow-up]
Вторичные конечные точки (11)
  • Estimate PrEP uptake among female participants [Срок оценки: 3-month follow-up]
  • HIV and Pregnancy characteristics [Срок оценки: Baseline and 3-month follow-up]
  • Physical health [Срок оценки: Baseline and 3-month follow-up]
  • Depression [Срок оценки: Baseline and 3-month follow-up]
  • Substance Use [Срок оценки: Baseline and 3-month follow-up]
  • Health beliefs [Срок оценки: Baseline]
  • Relationship characteristics and communication [Срок оценки: Baseline and 3-month follow-up]
  • Partner Violence [Срок оценки: Baseline and 3-month follow-up]
  • HIV-related stigma [Срок оценки: Baseline and 3-month follow-up]
  • Structural barriers [Срок оценки: Baseline and 3-month follow-up]
  • Demographics [Срок оценки: Baseline]

Критерии участия

Female Inclusion Criteria:

  • woman
  • Age ≥18
  • ≥30 weeks pregnant per medical record due date
  • non-reactive third trimester HIV test (verified from their antenatal care chart)
  • reporting at least one unknown-serostatus partner
  • fluent in English or isiZulu
  • willing to give researchers permission to contact them for repeated assessments
  • able to provide informed consent

Male Inclusion Criteria: partners meeting the inclusion criteria as described above, and who complete verification questions to confirm their identity and status as the partners of the enrolled female participants. Additional inclusion criteria for men include:

  • man
  • Age ≥18
  • partner of enrolled women, confirmed via couples verification tool
  • fluent in English or isiZulu
  • willing to give researchers permission to contact them
  • able to provide informed consent.

Exclusion Criteria: Individuals with significant psychiatric illness that could interfere with participation or the ability to provide informed consent will be excluded at the discretion of the study team.

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
Открытое
Основная цель
Организация здравоохранения

Центры проведения

ЮАР · 1 центр
  • Wits MatCH Research Unit — Durban

Публикации

  • Psaros C, Beesham I, Mosery N, Aoun ZR, Bhardwaj A, Ndlovu L, Ntanzi N, Pratt MC, Chikovore J, Smit JA, Matthews LT. HIV self-testing for partners of postpartum women to facilitate HIV pre-exposure prophylaxis and antiretroviral therapy uptake: a protocol to adapt and pilot an intervention via a pilot randomised controlled trial in South Africa. BMJ Open. 2026 Jun 9;16(6):e121917. doi: 10.1136/bmj PMID 42264526

Идентификаторы

NCT: NCT07194902 · 2025P002271 · R34MH132446

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗