Cervix Cancer, HIV Infections, HPV Infection
Conditions
Keywords
screening, self-collection
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.
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.
Interventions
DIAGNOSTIC_TESTModel 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_TESTModel 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
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Randomization is performed at the facility level. There will not be participant level randomization.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 49 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical cancer monthly screening rates | 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. |
Countries
Uganda
Contacts
CONTACTJennifer S Smith, PhD
CONTACTFranklin K Okwunze, MD
STUDY_CHAIRJennifer Tang, MD
UNC Lineberger Comprehensive Cancer Center
STUDY_CHAIRJennifer Smith, PhD
UNC Lineberger Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORBetty Mwesigwa, MD
Makerere University Walter Reed Program
STUDY_DIRECTORMichael Hudgens, PhD
University of North Carolina, Chapel Hill
STUDY_DIRECTORKatie Mollan, PhD
University of North Carolina, Chapel Hill
STUDY_DIRECTORVikrant Sahasrabuddhe, MBBS, MPH, DrPH
Division of Cancer Prevention (DCP), NCI
STUDY_DIRECTORMonica Etima, MD
Makerere University Walter Reed Program
STUDY_DIRECTORGrace Mirembe, MD
Makerere University Walter Reed Program
STUDY_DIRECTORFred Magala, MD
Makerere University Walter Reed Program
STUDY_DIRECTORStephen Mugamba, MD
Makerere University Walter Reed Program
STUDY_DIRECTORMichael Semwogerere, MD
Makerere University Walter Reed Program
STUDY_DIRECTORHannah Kibuuka, MD
Makerere University Walter Reed Program
STUDY_DIRECTORRobert Mutumba, MD
Ministry of Health, Uganda
STUDY_DIRECTORMina Nakawuka, MD
Ministry of Health, Uganda
STUDY_DIRECTORLameck Chinula, MD
University of North Carolina, Chapel Hill
STUDY_DIRECTORLisa Spees, PhD
University of North Carolina, Chapel Hill
STUDY_DIRECTORChemtai Mungo, MD MPH
University of North Carolina, Chapel Hill
STUDY_DIRECTORSue Siminski, MS MBA
Frontier Science Foundation
Outcome results
None listed