ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services

HIV Clinical Trial

— ACCESS  

Official title:

ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128304
• Other study ID #: U01CA275118
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: December 2023
• Source: University of California, San Diego
• Contact: Gregory Aarons, PhD
• Phone: +1 8583350700
• Email: gaarons[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2436
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women living with HIV Exclusion Criteria: -

Related Conditions & MeSH terms

• Cervical Cancer
• HIV
• Uterine Cervical Neoplasms

Intervention

Other:
• Core Implementation strategies
Core Implementation Strategies Ongoing consultation Educational meetings Strengthen referral system Prepare patients to be active participants
• 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

Locations

Country	Name	City	State
Nigeria	University of Nigeria, Nsukka	Enugu
United States	UC San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	University of Nigeria Nsukka

Countries where clinical trial is conducted

United States,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach	Percent of WLHIV who had cervical cancer (CC) screening	12 months after enrollment
Primary	Sustainment	Provider Report of Sustainment Scale (PRESS; Moullin et al., 2021). The PRESS has 3-items scored from 0 "not at all" to 4 "to a very great extent" where higher scores indicate better evidence-based practice sustainment.	3 months prior to study completion
Secondary	CCST Effectiveness	Percent of WLHIV treated for pre-invasive cancer who had negative post treatment follow-up screen	15 months after treatment of pre-invasive cancer