Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diagnostic Concordance of Self-Collected vs. Clinically collected sample (Phase I)
研究概览
简要总结
Phase I: Validating self-collection kit by comparing their results with clinical Pap smear results in a cohort of 20 patients.
Phase II: Evaluate the feasibility and acceptability of the CHW4CervicalHealth: Use of a self-collection kit to improve cervical health screening intervention aimed to promote HPV self-collection uptake among screening-eligible and under-screened ethnic minority women in the community.
详细描述
The self-collection kits will be collected at the clinic (Phase I) or at the end of the workshop (Phase II). A chain-of-custody form for each kit will be associated with the specimen and the clinic nurse will label and prepare to transport them via courier to the Jefferson NJ Molecular Virology lab, Cherry Hill, NJ; Richard Sunday, Lab Supervisor, will process according to Roche, the self-collected vaginal specimens suspended in PreservCyt® may be stored at 2-30°C (35.6- 86°F) for up to 1 month after the date of collection.
Phase I: In person accrual, enrollment and study implementation will take 15-30 minutes.
-Clinic staff will collect self-collection kit at appointment.
Phase II: Workshops will take about 30 minutes to complete and another 30 minutes to complete survey and self-collection kit use.
- Conduct educational workshops in participants primary language
- For those choosing to use the self-sample kit, obtain and document e-consent or paper consent from potential participants in their primary language.
- Provide participants with self-collection testing kits during workshop along with instructions
- Collect self-collection kit samples from participants and place in pre-made sample bags with appropriate label. CHW will take custody and coordinate with OBGYN clinic staff to drop off self-collected samples
- Collect post workshop survey and conduct post workshop interviews or focus group
- OBGYN staff set-up courier to send samples to NJ lab
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 25-65 years
- •Scheduled for a Pap smear test appointment at Jefferson OBGYN Center City location
- •Willing and able to provide informed consent for participation in the study
- •Agree to perform an HPV self-collection collection procedure during the same visit
- •Have not undergone a hysterectomy (intact cervix required)
- •This intervention targets under-screened minority individuals who must meet all the following inclusion criteria to be eligible to participate in the study:
- •Women aged 25-65 years
- •Who has not had a Pap smear in the past three to five years based on age of prior screening and type of screening. If under the age of 30, in the past 3 years and if over the age of 30, in the past 5 years. Participant will self-report normal pap smear and date.
- •Self-identify as Hispanic, Black/African or Black Caribbean, Chinese, Korean, or Vietnamese
- •Competent to give consent and provide signed and dated informed consent form in their preferred language.
排除标准
- •Current pregnancy (self-reported or confirmed)
- •Previous participation in an HPV self-collection study within the past 12 months
- •Presence of visible vaginal or cervical infection or symptoms suggestive of a current genital tract infection
- •Inability to comply with study procedures or follow instructions (e.g., due to language barriers or cognitive impairments)
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Have a history of hysterectomy, cervical cancer
- •Self-report participation in a cervical cancer screening or other prevention study
- •Pregnant (self-reported)
- •Inability to provide informed consent
研究组 & 干预措施
Arm 1: Evalyn Brush Self-Collection - Phase I (Validation)
Participants will be provided the Evalyn Brush self-sample kit at their scheduled Pap smear; a self-collected HPV test will also be collected as part of validation purposes for the study. Results will be shared from both their regularly scheduled appointment and the HPV self sample kit.
干预措施: Evalyn® Brush (Device)
Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation)
Participants will be assigned to use the Evalyn Brush device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.
干预措施: Evalyn® Brush (Device)
Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation)
Participants will be assigned to use the Evalyn Brush device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.
干预措施: CHW4CervicalHealth (Behavioral)
Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation)
Participants will be assigned to use the Copan FLOQSwab device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.
干预措施: Copan Floqswab (Device)
Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation)
Participants will be assigned to use the Copan FLOQSwab device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.
干预措施: CHW4CervicalHealth (Behavioral)
结局指标
主要结局
Diagnostic Concordance of Self-Collected vs. Clinically collected sample (Phase I)
时间窗: at the visit (approximately 30 minutes) and analysis completed within 2 weeks
Concordance rate between self-collection kit results and clinical Pap smear findings (measured as agreement in detection of HPV and/or abnormal cytology). Agreement between the two methods will be evaluated using Cohen's kappa statistic, with values interpreted based on standard benchmarks for strength of agreement. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) will be calculated to determine the accuracy of self-collection kits relative to the clinician-collected gold standard.
Feasibility of HPV Self-Collection: Completion of Self-Collection Kit
时间窗: Within 12 months
Feasibility will be assessed as the number of participants who proceed with HPV self-collection using the study kit out of the total number of participants enrolled in the study.
次要结局
- Change in Participants' HPV-related knowledge and perceived comfort with self-collection(From Baseline to Post-Intervention (approximately 18 months))