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

NCT ID: NCT06128304

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-13

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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HIV Cervical Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Core Implementation Strategies

Core Implementation Strategies

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

Group Type ACTIVE_COMPARATOR

Core Implementation strategies

Intervention Type 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

Intervention Type 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+ 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

Group Type EXPERIMENTAL

Core+ Enhanced Implementation Strategies

Intervention Type 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

Interventions

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Core Implementation strategies

Core Implementation Strategies

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women living with HIV

Exclusion Criteria

\-
Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Nigeria Nsukka

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Gregory Aarons

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory Aarons, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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UC San Diego

La Jolla, California, United States

Site Status RECRUITING

University of Nigeria, Nsukka

Enugu, Enugu State, Nigeria

Site Status RECRUITING

Countries

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United States Nigeria

Central Contacts

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Gregory Aarons, PhD

Role: CONTACT

Phone: 858-966-7703

Email: [email protected]

Echezona Ezeanolue, MD, MPH

Role: CONTACT

Phone: +234 803 773 9972

Email: [email protected]

Facility Contacts

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Joella Phillips, BA

Role: primary

Echezona Ezeanolue, MD, MPH

Role: primary

Tonia Onyeka

Role: backup

References

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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.

Reference Type DERIVED
PMID: 38468266 (View on PubMed)

Other Identifiers

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U01CA275118

Identifier Type: NIH

Identifier Source: org_study_id

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