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NCT Number: NCT07624123

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

This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE)-3001-B 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 (CHWs) 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.

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Key information

Conditions

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

Age range

25 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Zimbabwe Clinical Trials Research Centre

Harare, 263-772287143, Zimbabwe

Location contact

Bothwell T Guzha, MD

CONTACT

[email protected]

263-772287143

Bothwell T Guzha, MD

PRINCIPAL_INVESTIGATOR

About this study

The feasibility phase of 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 main study phase of the C3001-B trial will include a total of 20 clinics which will be enrolled in a stepped-wedge cluster randomized into Models 1 and 2 as described below. The feasibility phase of the study (C3001B-P-CS7) will include a total of 6 clinics, and the main phase of the study, if approved, will include 20 clinics. Trial dates and sample sizes are estimated for 26 clinics total. The feasibility phase of 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 the Zimbabwe National Screening 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 Visual Inspection with Acetic Acid and Cervicography (VIAC), 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 <6 weeks 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

Treatment and study plan

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 and Cervicography (VIAC), 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.

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 Community Health workers (CHWs). 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.

Primary outcomes

  1. 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 community health workers (CHWs)(Model 2).

    Standard-of-care for Model 1 is defined as HPV self-collection when available or Visual Inspection with Acetic Acid and Cervicography (VIAC) when HPV-based screening is not available.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Smith, PhD

CONTACT

[email protected]

919-445-6911

Poonam Rawat, MPH

CONTACT

[email protected]

919-445-6911

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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 (CASCADE-3001-B)

Acronym: C-3001B-P-CS7

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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