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

Emory University

Status: Enrolling

Conditions: HIV; Cervical Cancer

Treatments: Diagnostic Test: GeneXpert HPV test; Behavioral: The Mother Mentor program

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06751030

U01CA275113 (U.S. NIH Grant/Contract)

STUDY00004817

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

Women living with HIV

Description:

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.

Treatment:

Behavioral: The Mother Mentor program

Diagnostic Test: GeneXpert HPV test