Recruiting

Cervical Cancer

Sponsor:

UCLA

Code:

NCT06128304

Conditions

HIV

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 25 - 64

Healthy Volunteers: Not accepted

Interventions

Core Implementation strategies

Core+ Enhanced Implementation Strategies

Study Details

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

Study ID

NCT06128304

Start date

Nov 13, 2023

Status verified date

Jan, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women living with HIV

Exclusion Criteria:

\-

Study Design

Enrollment

2436 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

Core Implementation strategies

Core Implementation Strategies

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

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 ]
  • Sustainment [ Time Frame: 3 months prior to study completion ]

Central Contacts and Locations

Central contacts

Gregory Aarons, PhD

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

Echezona Ezeanolue, MD, MPH

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

Locations

UC San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Joella Phillips, BA

8589667703jiphillips@ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 10, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-02-10.