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

December 29, 2023 updated by: Gregory Aarons, University of California, San Diego
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women living with HIV

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 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
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach
Time Frame: 12 months after enrollment
Percent of WLHIV who had cervical cancer (CC) screening
12 months after enrollment
Sustainment
Time Frame: 3 months prior to study completion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CCST Effectiveness
Time Frame: 15 months after treatment of pre-invasive cancer
Percent of WLHIV treated for pre-invasive cancer who had negative post treatment follow-up screen
15 months after treatment of pre-invasive cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

University of Nigeria Nsukka

Investigators

  • Principal Investigator: Gregory Aarons, PhD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01CA275118 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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