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Идёт набор NCT06751030

Community, Home-based Education, Screening Services Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria

— Наблюдательное HIV Cervical Cancer

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: The Mother Mentor program, GeneXpert HPV test.
Кому может быть актуально
Состояния в реестре: HIV, Cervical Cancer. Базовые параметры: 25 лет — 50 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
Nigeria
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

Community, Home-based Education, Screening Services (CHESS) Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria

Обзор

The goal of this observational study is to focus on adapting and implementing a program to promote HPV and cervical cancer (CC) screening and follow-up treatment for HIV-positive women, with three specific aims: * Adaptation: Use stakeholder deliberation to tailor the successful MoMent program for this population. * Implementation and Assessment: Deploy the adapted MoMent program and evaluate its reach, effectiveness, adoption, and fidelity. * Evaluation: Conduct a post-implementation process evaluation to identify barriers and facilitators to the program's maintenance and sustainability.

Подробное описание

Despite the increased risk of cervical cancer (CC) among women living with HIV (WLWH), access to CC screening in Nigeria remains limited. While advances in prevention programs and antiretroviral therapy have reduced other AIDS-associated malignancies, CC risk in WLWH persists. This study aims to leverage Nigeria's existing HIV treatment infrastructure to integrate home-based CC (HCC) screening for WLWH.

The approach involves adapting the MoMent (MOther MENTor) peer-based HIV support program to include HCC screening and evaluating its implementation and sustainability using the Consolidated Framework for Implementation Research (CFIR) and RE-AIM frameworks. The study has three key aims:

* Adapting the MoMent program to promote home-based HPV screening and follow-up treatment through stakeholder deliberation. * Implementing and assessing the program's reach, effectiveness, adoption, and fidelity with a sample of 1,500 WLWH. * Conducting a post-implementation evaluation to identify barriers and enablers for program maintenance and scalability.

Stakeholder input, including perspectives from WLWH, peer counselors, clinical managers, and policymakers, will guide the program's design and execution. By integrating stakeholder insights and addressing systemic challenges, the study aims to advance CC control in Nigeria and provide a scalable model for implementing cancer control strategies for people living with HIV in low- and middle-income countries globally.

Вмешательства

  • Поведенческое The Mother Mentor program
    The MOther MENTor (MoMent) program in Nigeria pairs trained treatment-experienced Women living with HIV (WLWH), known as Mentor Mothers (MMs), with new mothers who are newly diagnosed with HIV to improve access to and retention in HIV care
  • Диагностический тест GeneXpert HPV test
    A cervical cancer screening tool.

Первичные конечные точки

  • Program Reach [Срок оценки: Baseline, Month 6, Month 18]
  • Effectiveness of the Program [Срок оценки: Baseline, Month 6, Month 18]
  • Adoption of the program [Срок оценки: Baseline, Month 6, Month 18]
  • Fidelity of the program [Срок оценки: Baseline, Month 6, Month 18]

Критерии участия

Критерии включения

\- Patients must be able to perform vaginal self-collection as well as give informed consent

Критерии исключения

  • Male gender
  • Age <25 or >50
  • Unknown or negative HIV status
  • Pregnancy
  • Hysterectomy
  • Inability to give informed consent Inability/refusal to perform vaginal self-collection

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Nigeria · 3 центра
  • APIN Health Initiatives — Abuja
  • University of Ibadan — Ibadan
  • Nigeria Institute of Medical Research (NIMR — Lagos

Публикации

  • Ogunsola O, Gaydos LM, Ajayi O, Dieci M, Kaonga N, Awolude O, Ezemelue P, Staple T, Salami K, Idigbe I, Ezechi O, Flowers L. The CHESS Protocol: A Mixed-Methods Evaluation of an HPV Screening Intervention for Women Living With HIV in Nigeria. Int J Public Health. 2025 Aug 14;70:1608716. doi: 10.3389/ijph.2025.1608716. eCollection 2025. PMID 40895387

Идентификаторы

NCT: NCT06751030 · STUDY00004817 · U01CA275113

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗