HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals

Официальное название

Advancing Cervical Cancer Screening Through Self-Sampling (ACCESS): A Pilot Study of HPV Self-sampling for Cervical Cancer Prevention in Washington State

Обзор

The objective of this study is to evaluate self-collection of vaginal samples for HPV testing as an alternative cervical cancer screening strategy for persons with HIV and/or limited access to care. Self-collection kits will be offered to persons who refuse a Pap smear or are overdue (\>=6 months) for cervical cancer screening, with screening uptake recorded as a primary outcome. Kits will be offered in-clinic to individuals who refuse a Pap smear, and individuals overdue for screening will have the option to receive and return kits in the mail. The investigators will additionally administer a phone-based survey to evaluate knowledge about HPV and cervical cancer, barriers and facilitators to screening, and attitudes towards screening. Data from medical records will be abstracted to describe the clinical characteristics of the sample and measure receipt of follow-up procedures. Focus groups will be conducted with clinic administrators, staff, and HIV and women's health experts to evaluate clinic and provider barriers and facilitators to cervical cancer screening. The investigators hypothesize that HPV self-sampling will result in favorable patient-centered outcomes and could reduce disparities in access to screening.

Вмешательства

• Устройство Flocked swab paired with Roche Cobas 4800
  Consenting individuals will insert the sterile flocked swab into the vagina, rotate at least once, and store in the provided dry tube. The sample will be stored at ambient temperature and routed to the lab for HPV testing with Roche Cobas 4800.

Первичные конечные точки

• Proportion of eligible individuals who accept self-sampling kits [Срок оценки: Baseline (during clinical and/or study recruitment encounter)]
• Proportion of eligible individuals who submit self-sampled specimens [Срок оценки: 3 weeks from enrollment]
• Satisfaction with self-collection [Срок оценки: Within 2 weeks of sample collection]
• Confidence with self-collection [Срок оценки: Within 2 weeks of sample collection]
• Recommendation of self-collection [Срок оценки: Within 2 weeks of sample collection]
• Ease of returning home kits [Срок оценки: Within 2 weeks of sample collection]

Вторичные конечные точки (9)

• Proportion of eligible individuals who return samples with adequate specimens [Срок оценки: 3 weeks from enrollment]
• Knowledge about HPV and cervical cancer screening [Срок оценки: Baseline]
• Perceived risk of cervical cancer [Срок оценки: Baseline]
• Attitudes and preferences for screening [Срок оценки: Baseline]
• HPV prevalence checklist [Срок оценки: Baseline]
• Receipt of follow-up care [Срок оценки: Up to 6 months after self-sampling]
• Reflex cytology results checklist [Срок оценки: Up to 6 months after self-sampling]
• Colposcopy results checklist [Срок оценки: Up to 6 months after self-sampling]
• Provider and/or clinic barriers and facilitators to cervical cancer screening survey [Срок оценки: During study year 1]

Критерии участия

Критерии включения

• Age >=25 and <65 (individuals without diagnosed HIV) or >=30 years (individuals with diagnosed HIV)
• Female sex at birth
• Proficient in English or Spanish
• Refused a Pap smear or are >=6 months overdue for cervical cancer screening

Критерии исключения

• Current pregnancy
• Complete hysterectomy
• History of cervical cancer
• Unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 3 центра

• SHE Clinic — Seattle
• Madison Clinic — Seattle
• MAX Clinic — Seattle

Идентификаторы

NCT: NCT05528237 · STUDY00014442 · 5KL2TR002317-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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