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

NCT ID: NCT06751030

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2026-06-30

Brief 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.

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.

Conditions

HIV; Cervical Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women living with HIV

During the screening process:

• Women testing negative for high-risk HPV (HrHPV) will complete participation one year after their test results, at which time they will be invited to retest.
• Women living with HIV (WLWH) testing positive for HrHPV will have endpoints based on treatment outcomes:

• Other HrHPV types (not 16/18/45):

• Endpoint: One year post-VIA (visual inspection with acetic acid).
• VIA-positive patients will receive thermal ablation treatment.
• VIA-negative patients will have repeat VIA or standard screening after one year.
• HrHPV types 16/18/45:

• Endpoint: Two years post-treatment.
• Follow-up includes repeat HPV self-collection, VIA, biopsies, and further treatment (thermal ablation or excision) if needed.

WLWH testing positive for HrHPV 16/18/45 via self-collection will be notified by a Mentor Mother, who, along with Nigerian clinical staff, will assist in scheduling VIA. Treatment follows the standard of care protocol.

The Mother Mentor program

Intervention Type: BEHAVIORAL

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

GeneXpert HPV test

Intervention Type: DIAGNOSTIC_TEST

A cervical cancer screening tool.

Interventions

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

Intervention Type: BEHAVIORAL

GeneXpert HPV test

A cervical cancer screening tool.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

MoMent Program

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Lisa Flowers

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Flowers, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

APIN Health Initiatives

Abuja, , Nigeria

Site Status: RECRUITING

University of Ibadan

Ibadan, , Nigeria

Site Status: RECRUITING

Nigeria Institute of Medical Research (NIMR

Lagos, , Nigeria

Site Status: RECRUITING

Countries

Nigeria

Central Contacts

Lisa Flowers, MD, MPH

Role: CONTACT

Lflowe2@emory.edu

404-712-3522

Facility Contacts

Olabanjo Ogunsola

Role: primary

Olutosin Awolude, MBBS, MSc

Role: primary

Oliver Ezechi, MBBS,PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40895387 (View on PubMed)

Other Identifiers

U01CA275113

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004817

Identifier Type: -

Identifier Source: org_study_id