Comparing clinic-only versus clinic plus community outreach to offer HPV self-collection for cervical screening in women with HIV
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
This project will test whether adding community health worker outreach to clinic services helps more women living with HIV complete HPV self-collection for cervical screening.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2912 (estimated) |
| Ages | 25 Years to 49 Years |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Kampala) |
| Trial ID | NCT07428330 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women living with HIV aged approximately 25–49 who attend or live in the catchment areas of participating clinics in Uganda and are due or overdue for HPV-based cervical screening are the ideal candidates.
Not a fit: Women who are not living with HIV, are outside the specified age range, do not attend participating clinics or live outside their catchment areas, or are already up-to-date with HPV-based screening are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could increase screening coverage among women living with HIV, enabling earlier detection and treatment of precancer and reducing cervical cancer incidence.
How similar studies have performed: Previous studies in low-resource settings have shown that HPV self-collection and community outreach can increase screening uptake, but combining these approaches specifically for women living with HIV at this scale has limited large-scale evidence.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Kampala
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.