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

NCT06751030 | Recruiting

• 2 other identifiers: STUDY00004817U01CA275113
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV; Cervical Cancer

Keywords

Women Living With HIV; cervical cancer screening

Outcome Measures

Primary Outcomes (4)

• Program Reach

  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

  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

  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

  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

Study Arms (1)

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; Diagnostic Test: GeneXpert HPV test

Interventions

The Mother Mentor program 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

Also known as: MoMent Program

Women living with HIV

GeneXpert HPV test DIAGNOSTIC_TEST

A cervical cancer screening tool.

Women living with HIV

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

APIN Health Initiatives

Abuja, Nigeria

RECRUITING

University of Ibadan

Ibadan, Nigeria

RECRUITING

Nigeria Institute of Medical Research (NIMR

Lagos, Nigeria

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lisa Flowers, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Flowers, MD, MPH

CONTACT

404-712-3522; Lflowe2@emory.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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
• 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.

Locations

NG (3)