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

Recruiting

• Conditions: HIV; Cervical Cancer

• Registration Number: NCT06751030
• Lead Sponsor: Emory University

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-01
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Program Reach	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.
Effectiveness of the Program	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.
Adoption of the program	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
Fidelity of the program	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

Trial Locations

Locations (3)

APIN Health Initiatives; 🇳🇬 Abuja, Nigeria

University of Ibadan; 🇳🇬 Ibadan, Nigeria

Nigeria Institute of Medical Research (NIMR; 🇳🇬 Lagos, Nigeria