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

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ClinicalTrials.gov Identifier: NCT06128304
Recruitment Status : Recruiting
First Posted : November 13, 2023
Last Update Posted : January 3, 2024
Sponsor:
Collaborator:
University of Nigeria Nsukka
Information provided by (Responsible Party):
Gregory Aarons, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
HIV Cervical Cancer Other: Core Implementation strategies Other: Core+ Enhanced Implementation Strategies Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services
Actual Study Start Date : November 13, 2023
Estimated Primary Completion Date : August 31, 2026
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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





Primary Outcome Measures :
  1. Reach [ Time Frame: 12 months after enrollment ]
    Percent of WLHIV who had cervical cancer (CC) screening

  2. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women living with HIV

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06128304


Contacts
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Contact: Gregory Aarons, PhD +1 8583350700 gaarons@health.ucsd.edu
Contact: Echezona Ezeanolue, MD, MPH +234 803 773 9972 echezona.ezeanolue@unn.edu.ng

Locations
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United States, California
UC San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Joella Phillips, BA    858-966-7703 ext 2695    jiphillips@ucsd.edu   
Nigeria
University of Nigeria, Nsukka Recruiting
Enugu, Nigeria
Contact: Echezona Ezeanolue, MD, MPH    +1 7024991082    echezona.ezeanolue@unn.edu.ng   
Contact: Tonia Onyeka    +234 806 356 3223    tonia.onyeka@unn.edu.ng   
Sponsors and Collaborators
University of California, San Diego
University of Nigeria Nsukka
Investigators
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Principal Investigator: Gregory Aarons, PhD University of California, San Diego
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Responsible Party: Gregory Aarons, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT06128304    
Other Study ID Numbers: U01CA275118 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2023    Key Record Dates
Last Update Posted: January 3, 2024
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gregory Aarons, University of California, San Diego:
Implementation Science
Cluster randomized trial
Capacity building
Low and middle income countries
Research infrastructure
Exploration Preparation Implementation Sustainment (EPIS)
EPIS Framework
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases