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

Last updated: December 20, 2024
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Pelvic Cancer

Cervical Cancer

Treatment

GeneXpert HPV test

The Mother Mentor program

Clinical Study ID

NCT06751030
STUDY00004817
U01CA275113
  • Ages 25-50
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must be able to perform vaginal self-collection as well as give informedconsent

Exclusion

Exclusion Criteria:

  • Male gender

  • Age <25 or >50

  • Unknown or negative HIV status

  • Pregnancy

  • Hysterectomy

  • Inability to give informed consent Inability/refusal to perform vaginalself-collection

Study Design

Total Participants: 1500
Treatment Group(s): 2
Primary Treatment: GeneXpert HPV test
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
June 30, 2026

Study Description

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.

Connect with a study center

  • APIN Health Initiatives

    Abuja,
    Nigeria

    Active - Recruiting

  • University of Ibadan

    Ibadan,
    Nigeria

    Active - Recruiting

  • Nigeria Institute of Medical Research (NIMR

    Lagos,
    Nigeria

    Active - Recruiting

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