ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Core Implementation strategies, Core+ Enhanced Implementation Strategies.
- Who it may be relevant to
- Registry conditions: HIV, Cervical Cancer. Basic parameters: 25 years — 64 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Core Implementation strategies
Core Implementation Strategies 1. Ongoing consultation 2. Educational meetings 3. Strengthen referral system 4. Prepare patients to be active participants - Other Core+ Enhanced Implementation Strategies
Includes all of the Core implementation strategies and adds: 5\. Community engagement using Health Beginning Initiative Model 6\. Smart Cards to facilitate patient engagement
Primary outcome measures
- Reach [Time frame: 12 months after enrollment]
- Sustainment [Time frame: 3 months prior to study completion]
Secondary outcome measures (1)
- CCST Effectiveness [Time frame: 15 months after treatment of pre-invasive cancer]
Eligibility criteria
Inclusion criteria
- Women living with HIV
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- UC San Diego — La Jolla
Nigeria · 1 center
- University of Nigeria, Nsukka — Enugu
Publications
- Olakunde BO, Itanyi IU, Olawepo JO, Liu L, Bembir C, Idemili-Aronu N, Lasebikan NN, Onyeka TC, Dim CC, Chigbu CO, Ezeanolue EE, Aarons GA. Comparative effectiveness of implementation strategies for Accelerating Cervical Cancer Elimination through the integration of Screen-and-treat Services (ACCESS study): protocol for a cluster randomized hybrid type III trial in Nigeria. Implement Sci. 2024 Mar PMID 38468266
Identifiers
NCT: NCT06128304 · U01CA275118