Comparing clinic-only versus clinic plus community outreach to offer HPV self-collection for cervical screening in women with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a parallel, open-label, cluster randomized implementation trial randomizing 33 clinics 1:1 to two models of offering HPV self-collection for cervical screening. Model 1 offers screening only at clinics while Model 2 adds community-health-worker–facilitated outreach alongside clinic services. The trial includes a 6-clinic feasibility phase and a planned main phase covering an additional 27 clinics, enrolling women living with HIV who are eligible for HPV-based cervicovaginal testing per national guidelines. Mixed-methods implementation outcomes will be collected to compare uptake, triage pathways for HPV-positive women, and feasibility of integrating optimized treatment algorithms into routine care.

Why it matters

Who can join: the full rules

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

Where it's running

• Makerere University Walter Reed Program
  Kampala, Uganda Recruiting

Study contacts

• Principal investigator: Betty Mwesigwa, MD — Makerere University Walter Reed Program
• Study coordinator: Jennifer S Smith, PhD
• Email: jennifers@unc.edu
• Phone: 919-966-4432

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.