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

NCT06128304 | Recruiting

• 1 other identifier: U01CA275118
• Study Type: interventional
• Target: 2,436
• Locations: 2 countries
• Sites: 2

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.

Conditions

HIV; Cervical Cancer

Keywords

Implementation Science; Cluster randomized trial; Capacity building; Low and middle income countries; Research infrastructure; Exploration Preparation Implementation Sustainment (EPIS); EPIS Framework

Outcome Measures

Primary Outcomes (2)

• Reach

  Percent of WLHIV who had cervical cancer (CC) screening

  12 months after enrollment

• 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 Outcomes (1)

• CCST Effectiveness

  15 months after treatment of pre-invasive cancer

Study Arms (2)

Core Implementation Strategies

ACTIVE COMPARATOR

Core Implementation Strategies 1. Ongoing consultation 2. Educational meetings 3. Strengthen referral system 4. Prepare patients to be active participants

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

Core+ Enhanced Implementation Strategies

EXPERIMENTAL

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

Interventions

Core+ Enhanced Implementation Strategies OTHER

Includes all of the Core implementation strategies and adds: 5\. Community engagement using Health Beginning Initiative Model 6\. Smart Cards to facilitate patient engagement

Core Implementation Strategies; Core+ Enhanced Implementation Strategies

Core Implementation strategies OTHER

Core Implementation Strategies 1. Ongoing consultation 2. Educational meetings 3. Strengthen referral system 4. Prepare patients to be active participants

Core Implementation Strategies

Eligibility Criteria

• Age: 25 Years - 64 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women living with HIV

Sponsors & Collaborators

• University of California, San Diego: lead
• University of Nigeria Nsukka: collaborator

Study Sites (2)

UC San Diego

La Jolla, California, 92093, United States

RECRUITING

University of Nigeria, Nsukka

Enugu, Enugu State, Nigeria

RECRUITING

Related Publications (1)

• 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 11;19(1):25. doi: 10.1186/s13012-024-01349-9.

  PMID: 38468266 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregory Aarons, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Aarons, PhD

CONTACT

858-966-7703; gaarons@health.ucsd.edu

Echezona Ezeanolue, MD, MPH

CONTACT

+234 803 773 9972; echezona.ezeanolue@unn.edu.ng

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: November 13, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1); US (1)