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

UNC Lineberger Comprehensive Cancer Center

Status: Enrolling

Conditions: HPV Infection; HIV Infections; Cervix Cancer

Treatments: Diagnostic Test: Model 1- Screening in Clinic Only; Diagnostic Test: Model 2 - Screening in Clinic and Community

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07428330

UG1CA275412 (U.S. NIH Grant/Contract)

UG1CA275403 (U.S. NIH Grant/Contract)

24-0684

U24CA275417 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,597 estimated patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,597 participants in 2 patient groups

Participants enrolled at Model 1 Clinics

Experimental group

Description:

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

Treatment:

Diagnostic Test: Model 1- Screening in Clinic Only

Participants enrolled at Model 2 Clinic s

Experimental group

Description:

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

Treatment:

Diagnostic Test: Model 2 - Screening in Clinic and Community