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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06128304
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • 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+ 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

Study Details

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.

Key Dates

Start date
Nov 13, 2023
Status verified
Jan 2026
Primary completion
Dec 1, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
2,436 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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
  • 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

Primary Outcome Measure

Reach [ Time Frame: 12 months after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC San DiegoLa JollaCalifornia92093
Joella Phillips, BA
8589667703

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