Juntas Contra el Virus del Papiloma Humano: protocol for a pilot randomized controlled trial of an HPV self-sampling intervention for underscreened Latinas

BACKGROUND: Rates of cervical cancer incidence and mortality are persistently higher among Latina women in the continental United States (US) and women in Puerto Rico (a US territory) compared with non-Hispanic White (NHW) women. Multiple factors contribute to low participation in cancer screening, including structural barriers (e.g., low access to healthcare services, racism/discrimination, lack of culturally and linguistically adequate information), cultural concerns, and low perceived risk and awareness of cervical cancer. Although community-based education and navigation support can be effective in overcoming some barriers to screening, structural barriers and limited access remain formidable challenges to overcome. Emerging technologies supporting self-sampling for high-risk human papillomavirus (HPV) testing may offer a valuable evidence-based strategy for empowering Latina women to engage in cervical cancer screening. Thus, the objective of this study is to assess the feasibility and acceptability of a novel HPV self-sampling intervention for underscreened Latina women.

METHODS: The study will be a randomized controlled feasibility trial involving 100 Latina women who have not received cervical cancer screening within the recommended guidelines. Participants will be randomly assigned to the intervention condition, which includes a synchronous three-session group cervical cancer educational program delivered virtually along with a mailed HPV self-sampling kit (to obtain self-collected cervical samples for HPV testing), or to a comparison condition that involves receipt of the mailed HPV self-sampling kit with written information about cervical cancer screening and nearby clinics. Study assessments will be obtained at baseline (i.e., study entry) and 1-month post-program. The primary outcome of feasibility will be measured through study enrollment and intervention completion. In addition, acceptability of study materials and the self-sampling procedures will be assessed using self-report surveys at 1-month post-program.

DISCUSSION: Provision of a mailed HPV self-sampling kit may present new options for encouraging participation in cervical cancer screening among underscreened Latina women. This study will evaluate the feasibility and acceptability of such an approach, which will inform the subsequent design of a full-scale randomized trial to assess intervention effectiveness on screening behavior.

TRIAL REGISTRATION: ClinicalTrials.gov no. NCT06439706. Registered 28 May 2024 - retrospectively registered.