Clinical trial NCT06128304: ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services
Official title: ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Cervical Cancer
Keywords: Implementation Science
Cluster randomized trial
Capacity building
Low and middle income countries
Research infrastructure
Exploration Preparation Implementation Sustainment (EPIS)
EPIS Framework
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of Nigeria Nsukka
First posted: 2023-11-13
Enrollment: 2436
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: While there has been a significant increase in the uptake of antiretroviral therapy among women living with HIV (WLHIV) in many low- and-middle income countries (LMICs), the coverage of cervical cancer screening and treatment (CCST) among WLHIV remains low. This study aims to leverage the available infrastructure for HIV care and treatment programs in Nigeria to integrate cervical cancer screening and treatment and conduct a cluster randomized, hybrid type III trial design to assess the comparative effectiveness of a Core set of implementation strategies versus a Core+ (enhanced) set of implementation strategies to implement cervical cancer screening, onsite treatment, referral and referral completion, treatment, and retention in care among WLHIV. The overarching goal is to improve the health and life expectancy of WLHIV with co-occurring cervical cancer.

Detailed description: Nigeria has one of the largest HIV epidemics in the world with 1.8 million people living with HIV infection. With an estimated female population of 102 million and HIV prevalence of 1.6% among adult females, Nigeria has the largest population of women and the 4th largest number of women living with HIV (WLHIV) in Africa. Although access to antiretroviral therapy (ART) among WLHIV in Nigeria has increased over the years, with over 98% of the 960,000 WLHIV on ART, AIDS-related mortality remains high. In 2020, 16,000 WLHIV died from AIDS- related illnesses including cervical cancer. A pilot implementation program in Nigeria demonstrated that leveraging the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) supported HIV programs for the provision of evidence-based cervical cancer screen-and-treat interventions in WLHIV is feasible. The pilot program demonstrated, however, that tailored implementation strategies will be needed to address specific multilevel barriers along the cancer control continuum in order to address adoption, reach, and sustainability that are necessary for successful scale-up. However, in many African countries with a high burden of both HIV and cervical cancer, there is a paucity of evidence-based implementation strategies to inform effective integration of HIV and cervical cancer services delivery. Objectives of this proposal are to: 1) Refine strategies to integrate cervical cancer screening, treatment and management within existing comprehensive HIV treatment programs and determine implementation readiness; 2) Determine the comparative effectiveness of a Core set of implementation strategies versus Core+ enhanced implementation strategies; and 3) assess sustainment of the integration of cervical cancer screening, treatment, and management intervention into HIV programs. The investigators have assembled a strong team from University of California San Diego, the University of Nigeria, Nsukka, and Northeastern University with expertise in implementation science, HIV care and research, and cancer care and research. Our proposal is responsive to the NCI request for applications (RFA) and consistent with the World Health Organization global plan of elimination of cervical cancer by 2030. If effective, the proposed project will result in a set of feasible, culturally adaptable, and sustainable implementation strategies to integrate evidence-based cervical cancer screening and treatment into HIV programs in order to improve the health and life expectancy of WLHIV.

Eligibility criteria: Inclusion Criteria:

* Women living with HIV

Exclusion Criteria:

-

Primary outcomes:
measure: Reach
timeFrame: 12 months after enrollment
measure: Sustainment
timeFrame: 3 months prior to study completion
Secondary outcomes:
measure: CCST Effectiveness
timeFrame: 15 months after treatment of pre-invasive cancer
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: Enugu
country: Nigeria
facility: University of Nigeria, Nsukka
Study officials:
affiliation: University of California, San Diego
name: Gregory Aarons, PhD
role: PRINCIPAL_INVESTIGATOR
References: