Fang Carolyn Y, Cora-Cruz Marisol, Koirala Pratistha, Perez Sophia, Li Minzi, Egleston Brian L, Chen Yuku, Mantia-Smaldone Gina, Martinez Omar
Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Ave., Philadelphia, PA, 19111, USA.
Department of Gynecologic Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Pilot Feasibility Stud. 2025 May 10;11(1):65. doi: 10.1186/s40814-025-01648-y.
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.
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.
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.
ClinicalTrials.gov no. NCT06439706. Registered 28 May 2024 - retrospectively registered.
与非西班牙裔白人（NHW）女性相比，美国大陆的拉丁裔女性以及波多黎各（美国领土）的女性宫颈癌发病率和死亡率一直较高。导致癌症筛查参与率低的因素有很多，包括结构性障碍（如获得医疗服务的机会少、种族主义/歧视、缺乏文化和语言上合适的信息）、文化问题以及对宫颈癌的低感知风险和认知度。尽管基于社区的教育和导航支持在克服一些筛查障碍方面可能有效，但结构性障碍和有限的获得机会仍然是难以克服的巨大挑战。支持高危人乳头瘤病毒（HPV）检测自我采样的新兴技术可能为促使拉丁裔女性参与宫颈癌筛查提供一种有价值的循证策略。因此，本研究的目的是评估一种针对筛查不足的拉丁裔女性的新型HPV自我采样干预措施的可行性和可接受性。
该研究将是一项随机对照可行性试验，涉及100名未按照推荐指南进行宫颈癌筛查的拉丁裔女性。参与者将被随机分配到干预组，该组包括一个同步的为期三节课的宫颈癌虚拟教育项目，同时邮寄HPV自我采样试剂盒（用于获取自我采集的宫颈样本进行HPV检测），或者分配到对照组，该组只收到邮寄的HPV自我采样试剂盒以及关于宫颈癌筛查和附近诊所的书面信息。研究评估将在基线（即研究入组时）和项目结束后1个月进行。可行性的主要结果将通过研究入组和干预完成情况来衡量。此外，将在项目结束后1个月使用自我报告调查来评估研究材料和自我采样程序的可接受性。
提供邮寄的HPV自我采样试剂盒可能为鼓励筛查不足的拉丁裔女性参与宫颈癌筛查提供新的选择。本研究将评估这种方法的可行性和可接受性，这将为后续全面随机试验的设计提供信息，以评估干预措施对筛查行为的有效性。
ClinicalTrials.gov编号：NCT06439706。于2024年5月28日注册——追溯注册。
