Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV (CASCADE3001A)

May 26, 2026 updated by: UNC Lineberger Comprehensive Cancer Center

Comparison of Clinic-based Versus Clinic-plus Community Outreach-based Strategy Via HPV Self-Collection to Increase Uptake of Cervical Cancer Screening Among Women Living With HIV: a Cluster Randomized Trial

This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE) C3001-A trial aims to assess how the introduction of a community-health-worker-facilitated model, in addition to the existing static clinic-only model, influences the rates of cervical cancer screening uptake among women living with HIV (WLWH). This study involves offering human papillomavirus (HPV) self-collection for cervical cancer screening to eligible WLWH.

The 'CASCADE' Network is a clinical trials network aimed at improving cervical cancer screening, management, and pre-cancer treatment for WLWH, in various healthcare settings. The network will conduct implementation trials to improve the triage of HPV-positive WLWH, as well as algorithms to optimize access to and options for effective treatment. Trials will be conducted using a mixed-methods approach aimed at assessing implementation strategies and outcomes and their potential to integrate into existing health systems.

Further understanding of HPV-based community-based strategies to reach WLWH, and the acceptability, feasibility, appropriateness, and cost of these strategies will be valuable for cervical cancer screening programs serving WLWH. Inputs from various 'CASCADE' Clinical Sites (CS) regarding feasible screening outreach options available in their settings for WLWH have guided this study that focuses on evaluating a pragmatic HPV self-collection implementation model to improve access to screening.

While it is clear that HPV self-collection is a highly acceptable and feasible screening option, creating opportunities to conduct self-collection in alternative venues outside the clinic premises, and with the guidance of and facilitation by trusted community healthcare workers is an important implementation strategy that needs to be evaluated and considered for its potential benefit. Studies have not yet evaluated a community-based approach for HPV self-collection kit distribution among WLWH - who may have different characteristics, preferences, and access to screening services than women not living with HIV. Providing WLWH with the option of receiving HPV self-collection kits in their own homes or other community-based settings ('community-based HPV self-collection') is a novel implementation strategy that could improve cervical cancer screening rates among eligible women. Therefore, this novel trial aims to evaluate the feasibility and effectiveness of implementing community-based HPV self-collection among WLWH.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a parallel, 1:1, open label, cluster randomized trial to evaluate two implementation models to increase access to HPV self-collection for cervical cancer screening among WLWH. The C3001-A trial will include a total of 33 clinics which will be randomized into Models 1 and 2 as described below. The feasibility phase of the study (C3001A-P-CS1) will include a total of 6 clinics, and the main phase of the study, if approved, will include 27 additional clinics. Trial dates and sample sizes are estimated for 33 clinics total.

Study Type

Interventional

Enrollment (Estimated)

7597

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Uganda
      • Kampala, Uganda, 16524
        • Recruiting
        • Makerere University Walter Reed Program
        • Principal Investigator:
          • Betty Mwesigwa, MD
        • Principal Investigator:
          • Fred Magala
        • Contact:
        • Principal Investigator:
          • Monica Etima
        • Principal Investigator:
          • Grace Mirembe
        • Principal Investigator:
          • Stephen Mugamba
        • Principal Investigator:
          • Michael Semwogerere
        • Principal Investigator:
          • Hannah Kibuuka
        • Principal Investigator:
          • Robert Mutumba
        • Principal Investigator:
          • Mina Nakawuka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Clinic Inclusion Criteria

  • Clinics selected for inclusion will include those clinics that provide Human Immunodeficiency Virus (HIV) care and distribute antiretroviral therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH.
  • These clinics should also have the ability to collect their own data.
  • Such clinics could be supported by national programs and bilateral donor-funded initiatives

Inclusion Criteria for Medical Record Abstraction

  • Are living with Human Immunodeficiency Virus (HIV)
  • Are 25-49 years of age, or as recommended by Uganda's Ministry of Health Cervical Cancer Prevention and Control Guidelines
  • Live in the catchment areas of or attend a study-eligible clinic
  • Are eligible for Human Papillomavirus (HPV)-based cervicovaginal testing either because:
  • They have never undergone cervical cancer screening before, or
  • They have never undergone HPV-based testing before and are now due for Acetic Acid (VIA), per national guidelines, or
  • They have previously undergone HPV-based testing, and are now due for follow-up HPV-based testing per national guidelines, and /or
  • They underwent ablative or excisional treatment for presumed or confirmed cervical dysplasia >1 year ago and have not had any follow-up cervical cancer screening since treatment.

Exclusion Criteria for Medical Record Abstraction

  • Have had their cervix removed
  • Are pregnant or <3 months post-delivery
  • Were positive on their most recent cervical cancer screening test and referred for further evaluation or treatment, but did not complete their referral
  • Have previously been treated for invasive cervical cancer

Clinic Inclusion Criteria

  • Clinics selected for inclusion will include those clinics that provide Human Immunodeficiency Virus (HIV) care and distribute antiretroviral therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH).
  • These clinics should also have the ability to collect their own data.
  • Such clinics could be supported by national programs and bilateral donor-funded initiatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants enrolled at Model 1 Clinics
Women living with Human Immunodeficiency Virus (WLWH) enrolled at Model 1 Clinic.
Diagnostic test: Model 1- Screening in Clinic Only
Model 1 involves only the recommended standard-of-care of cervical cancer screening Human Papillomavirus (HPV) self-collection, if available, or Visual Inspection with Acetic Acid (VIA), if HPV-based testing is not available) to clients who are due for screening at clinics that distribute Antiretroviral Therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH). Efforts will be made to ensure availability of HPV kits for Model 1 clinics.
Experimental: Participants enrolled at Model 2 Clinic s
Women living with Human Immunodeficiency Virus (WLWH) enrolled at Model 2 Clinics.
Diagnostic test: Model 2 - Screening in Clinic and Community
Model 2 will include clinic-based Human Papillomavirus (HPV) self-collection, as well as the implementation strategy of providing community-based distribution for HPV self-collection via Facility-link facilitator (FLF)s. Women living with Human Immunodeficiency Virus (WLWH) who are due and overdue for cervical cancer screening will be identified via line lists and appointment directories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical cancer monthly screening rates
Time Frame: Up to 1 month

Monthly cervical cancer screening rates among Women living with Human Immunodeficiency Virus (WLWH) will be compared between two models: (1) standard-of-care screening at static clinics only (Model 1) , and (2) Human Papillomavirus (HPV) self-collection offered at static clinics and through a community-based strategy by facility link facilitators (FLFs)(Model 2).

Standard-of-care for Model 1 is defined as HPV self-collection when available or Visual Inspection with Acetic Acid (VIA) when HPV-based screening is not available.
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Study Director: Michael Hudgens, PhD, University of North Carolina, Chapel Hill
  • Study Chair: Jennifer Tang, MD, UNC Lineberger Comprehensive Cancer Center
  • Study Director: Katie Mollan, PhD, University of North Carolina, Chapel Hill
  • Study Director: Vikrant Sahasrabuddhe, MBBS, MPH, DrPH, Division of Cancer Prevention (DCP), NCI
  • Study Chair: Jennifer Smith, PhD, UNC Lineberger Comprehensive Cancer Center
  • Principal Investigator: Betty Mwesigwa, MD, Makerere University Walter Reed Program
  • Study Director: Monica Etima, MD, Makerere University Walter Reed Program
  • Study Director: Grace Mirembe, MD, Makerere University Walter Reed Program
  • Study Director: Fred Magala, MD, Makerere University Walter Reed Program
  • Study Director: Stephen Mugamba, MD, Makerere University Walter Reed Program
  • Study Director: Michael Semwogerere, MD, Makerere University Walter Reed Program
  • Study Director: Hannah Kibuuka, MD, Makerere University Walter Reed Program
  • Study Director: Robert Mutumba, MD, Ministry of Health, Uganda
  • Study Director: Mina Nakawuka, MD, Ministry of Health, Uganda
  • Study Director: Lameck Chinula, MD, University of North Carolina, Chapel Hill
  • Study Director: Lisa Spees, PhD, University of North Carolina, Chapel Hill
  • Study Director: Chemtai Mungo, MD MPH, University of North Carolina, Chapel Hill
  • Study Director: Sue Siminski, MS MBA, Frontier Science Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0684
  • U24CA275417 (U.S. NIH Grant/Contract)
  • UG1CA275412 (U.S. NIH Grant/Contract)
  • UG1CA275403 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified research data will be made available to qualified researchers upon request one year after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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