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

August 4, 2025 updated by: Lisa Flowers, Emory University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nigeria
      • Abuja, Nigeria
        • Recruiting
        • APIN Health Initiatives
        • Contact:
          • Olabanjo Ogunsola
      • Ibadan, Nigeria
        • Recruiting
        • University of Ibadan
        • Contact:
          • Olutosin Awolude, MBBS, MSc
      • Lagos, Nigeria
        • Recruiting
        • Nigeria Institute of Medical Research (NIMR
        • Contact:
          • Oliver Ezechi, MBBS,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Aim 1: The stakeholder deliberation conferences will include stakeholders from the following groups:

  • State and National Policymakers
  • Organizational-clinical managers
  • Mentor mothers
  • Women living with HIV (WLWH) Since this is a socio-behavioral component, pregnant individuals may partake. All individuals who take part in this portion of the study will be above 18 and capable of providing informed consent.

Aim 2: This study will only include WLWH aged 25-50. Pregnant individuals will not be included due to the potential for treatment of precancerous lesions. All individuals who partake in the study will be older than 18 and capable of providing informed consent.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
Other Names:
  • MoMent Program
Diagnostic test: GeneXpert HPV test
A cervical cancer screening tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program Reach
Time Frame: Baseline, Month 6, Month 18
Reach evaluated through the provision of home test kits to eligible women, returned samples, number of WLWH positive for high-risk HPV (hrHPV) treated, persistence or reoccurrence of hrHPV or cervical precancerous lesions post-treatment, and correlation of these results with CD4 and HIV viral load.
Baseline, Month 6, Month 18
Effectiveness of the Program
Time Frame: Baseline, Month 6, Month 18
Effectiveness evaluated through the provision of home test kits to eligible women, returned samples, number of WLWH positive for high-risk HPV (hrHPV) treated, persistence or recurrence of hrHPV or cervical precancerous lesions post-treatment, and correlation of these results with CD4 and HIV viral load.
Baseline, Month 6, Month 18
Adoption of the program
Time Frame: Baseline, Month 6, Month 18
Adoption will be measured through the proportions of MMs who complete training and WLWH who return self-collected (SC) samples
Baseline, Month 6, Month 18
Fidelity of the program
Time Frame: Baseline, Month 6, Month 18
Will be measured by peer leaders' monitoring of practices, as well as measuring system barriers and added MoMent program costs per completed home screening
Baseline, Month 6, Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lisa Flowers, MD, MPH, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004817
  • U01CA275113 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data shared:

De-identified sociodemographic data (e.g., race/ethnicity, age). Health behavior and health care utilization data from medical records. Cervical pathology results, HPV testing data, laboratory tests (e.g., CD4 and viral load), prescribed HIV medications, and adherence data.

Qualitative data from in-depth interviews and focus group discussions, coded and anonymized.

IPD Sharing Time Frame

Start Date: After primary analyses have been completed and results are published (expected within 12 months of study completion).

End Date: Indefinitely, contingent on adherence to data-sharing agreements

IPD Sharing Access Criteria

Researchers will submit a Data Analysis Request Form, detailing their proposed analysis, purpose, and data needed.

Data access will be granted following review and approval. Approved users will sign a Data Use and Confidentiality Agreement. Anonymized data will be shared securely via a designated data repository or encrypted file transfer.

Researchers must commit to using the data for specified purposes, implementing secure data storage, and destroying or returning the data after analyses are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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