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Recruiting NCT06751030

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

Observational HIV Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Mother Mentor program, GeneXpert HPV test.
Who it may be relevant to
Registry conditions: HIV, Cervical Cancer. Basic parameters: 25 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Nigeria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed 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.

Interventions

  • Behavioral 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
  • Diagnostic test GeneXpert HPV test
    A cervical cancer screening tool.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

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

Publications

  • 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

Identifiers

NCT: NCT06751030 · STUDY00004817 · U01CA275113

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗