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

NCT07428330 | Recruiting DMC

• 4 other identifiers: 24-0684UG1CA275412UG1CA275403U24CA275417
• Study Type: interventional
• Target: 7,597
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervix Cancer; HIV Infections; HPV Infection

Keywords

screening; self-collection

Outcome Measures

Primary Outcomes (1)

• Cervical cancer monthly screening rates

  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

Study Arms (2)

Participants enrolled at Model 1 Clinics

EXPERIMENTAL

Women living with Human Immunodeficiency Virus (WLWH) enrolled at Model 1 Clinic.

Diagnostic Test: Model 1- Screening in Clinic Only

Participants enrolled at Model 2 Clinic s

EXPERIMENTAL

Women living with Human Immunodeficiency Virus (WLWH) enrolled at Model 2 Clinics.

Diagnostic Test: Model 2 - Screening in Clinic and Community

Interventions

Model 1- Screening in Clinic Only DIAGNOSTIC_TEST

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.

Participants enrolled at Model 1 Clinics

Model 2 - Screening in Clinic and Community DIAGNOSTIC_TEST

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.

Participants enrolled at Model 2 Clinic s

Eligibility Criteria

• Age: 25 Years - 49 Years
• Gender Eligibility Details: Women living with Human Immunodeficiency Virus (HIV) since they are at an increased risk of invasive cervical cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Makerere University Walter Reed Program

Kampala, 16524, Uganda

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Uterine Cervical Neoplasms; HIV Infections; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Tang, MD

  UNC Lineberger Comprehensive Cancer Center

  STUDY CHAIR

• Jennifer Smith, PhD

  UNC Lineberger Comprehensive Cancer Center

  STUDY CHAIR

• Betty Mwesigwa, MD

  Makerere University Walter Reed Program

  PRINCIPAL INVESTIGATOR

• Michael Hudgens, PhD

  University of North Carolina, Chapel Hill

  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 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

  STUDY DIRECTOR

Central Study Contacts

Jennifer S Smith, PhD

CONTACT

919-966-4432; jennifers@unc.edu

Franklin K Okwunze, MD

CONTACT

kokwunze@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization is performed at the facility level. There will not be participant level randomization.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

UG (1)