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

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

Interventions

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.

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Jennifer Tang, MD · UNC Lineberger Comprehensive Cancer Center

• Jennifer Smith, PhD · UNC Lineberger Comprehensive Cancer Center

• Betty Mwesigwa, MD · Makerere University Walter Reed Program

• Michael Hudgens, PhD · University of North Carolina, Chapel Hill

• Katie Mollan, PhD · University of North Carolina, Chapel Hill

• Vikrant Sahasrabuddhe, MBBS, MPH, DrPH · Division of Cancer Prevention (DCP), NCI

• Monica Etima, MD · Makerere University Walter Reed Program

• Grace Mirembe, MD · Makerere University Walter Reed Program

• Fred Magala, MD · Makerere University Walter Reed Program

• Stephen Mugamba, MD · Makerere University Walter Reed Program

• Michael Semwogerere, MD · Makerere University Walter Reed Program

• Hannah Kibuuka, MD · Makerere University Walter Reed Program

• Robert Mutumba, MD · Ministry of Health, Uganda

• Mina Nakawuka, MD · Ministry of Health, Uganda

• Lameck Chinula, MD · University of North Carolina, Chapel Hill

• Lisa Spees, PhD · University of North Carolina, Chapel Hill

• Chemtai Mungo, MD MPH · University of North Carolina, Chapel Hill

• Sue Siminski, MS MBA · Frontier Science Foundation

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-22

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• Uganda

Study Locations