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NCT Number: NCT06128304

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

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.

Recruiting

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Key information

Age range

25 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Nigeria, Nsukka, Enugu, Enugu State, Nigeria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women living with HIV

Exclusion criteria

-

Treatment and study plan

Core Implementation strategies

Other

Core Implementation Strategies

  • Ongoing consultation
  • Educational meetings
  • Strengthen referral system
  • Prepare patients to be active participants

Core+ Enhanced Implementation Strategies

Other

Includes all of the Core implementation strategies and adds:

  • Community engagement using Health Beginning Initiative Model
  • Smart Cards to facilitate patient engagement

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Echezona Ezeanolue, MD, MPH

CONTACT

[email protected]

+234 803 773 9972

Gregory Aarons, PhD

CONTACT

[email protected]

858-966-7703 ext. 90101

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • University of Nigeria Nsukka

Registry information

Acronym: ACCESS

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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