Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Model 1- Screening in Clinic Only, Model 2 - Screening in Clinic and Community.
- Who it may be relevant to
- Registry conditions: Cervix Cancer, HIV Infections, HPV Infection. Basic parameters: 25 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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 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.
Primary outcome measures
- Cervical cancer monthly screening rates [Time frame: Up to 1 month]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Uganda · 1 center
- Makerere University Walter Reed Program — Kampala
Identifiers
NCT: NCT07428330 · 24-0684 · UG1CA275412 · UG1CA275403 · U24CA275417