Clinical trial NCT06751030: Community, Home-based Education, Screening Services Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria
Official title: Community, Home-based Education, Screening Services (CHESS) Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Cervical Cancer
Keywords: Women Living With HIV
cervical cancer screening
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-12-27
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Program Reach
timeFrame: Baseline, Month 6, Month 18
measure: Effectiveness of the Program
timeFrame: Baseline, Month 6, Month 18
measure: Adoption of the program
timeFrame: Baseline, Month 6, Month 18
measure: Fidelity of the program
timeFrame: Baseline, Month 6, Month 18
Secondary outcomes:
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: APIN Health Initiatives
city: Ibadan
country: Nigeria
facility: University of Ibadan
city: Lagos
country: Nigeria
facility: Nigeria Institute of Medical Research (NIMR
Study officials:
affiliation: Emory University
name: Lisa Flowers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: