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

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

Tracking Information

• First Submitted Date: November 7, 2023
• First Posted Date: November 13, 2023
• Last Update Posted Date: January 3, 2024
• Actual Study Start Date: November 13, 2023
• Estimated Primary Completion Date: August 31, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 13, 2023)

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

Original Primary Outcome Measures (submitted: November 7, 2023)

• Reach [ Time Frame: 12 months after enrollment ]
  Percent of WLHIV who had cervical cancer (CC) screening
• Sustainment [ Time Frame: 3 months prior to study completion ]
  Moullin et al. (2021) (PRESS; 3-items) Provider Report of Sustainment Scale

Current Secondary Outcome Measures (submitted: November 7, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• HIV
• Cervical Cancer

Intervention

• 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

Study Arms

• 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
  Interventions:

  • Other: Core Implementation strategies
  • Other: Core+ Enhanced Implementation Strategies
• 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

  Intervention: Other: Core+ Enhanced Implementation Strategies

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 7, 2023): 2436
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2027
• Estimated Primary Completion Date: August 31, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Women living with HIV

Exclusion Criteria:

-

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Gregory Aarons, PhD; +1 8583350700; gaarons@health.ucsd.edu

Contact: Echezona Ezeanolue, MD, MPH; +234 803 773 9972; echezona.ezeanolue@unn.edu.ng

• Listed Location Countries: Nigeria, United States

Administrative Information

• NCT Number: NCT06128304
• Other Study ID Numbers: U01CA275118( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Gregory Aarons, University of California, San Diego
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, San Diego
• Original Study Sponsor: Same as current
• Collaborators: University of Nigeria Nsukka

Investigators

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

• PRS Account: University of California, San Diego
• Verification Date: December 2023