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

What this Trial Is About

Researchers are evaluating how adding a community-health-worker-facilitated approach to the existing clinic-only model affects cervical cancer screening rates among women living with HIV (WLWH). This trial focuses on offering human papillomavirus (HPV) self-collection for cervical cancer screening to eligible WLWH, aiming to improve screening access and uptake. The study is part of the CASCADE Network, which works to enhance cervical cancer screening, management, and treatment options for WLWH within various healthcare settings. The trial is a parallel, cluster randomized study involving 33 clinics divided into two groups. Model 1 clinics provide the standard care of clinic-based HPV self-collection or Visual Inspection with Acetic Acid (VIA) when HPV testing is unavailable. Model 2 clinics offer both clinic-based HPV self-collection and community-based distribution of HPV self-collection kits through facilitators who reach women in their homes or community settings. The trial includes a feasibility phase with 6 clinics and a main phase with 27 more clinics, assessing these two implementation models. Participants will be women living with HIV aged 25 to 49 who attend enrolled clinics or live in their catchment areas. Researchers will track cervical cancer screening rates monthly and monitor outcomes up to one month. Data collection includes screening uptake through medical record abstraction. The study also evaluates the feasibility, acceptability, and cost of the community-based approach. Participation involves receiving HPV self-collection kits either in the clinic or community and following up according to national guidelines.

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