A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System Asian/Asian American Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Primary screening participation
研究概览
简要总结
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.
详细描述
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. The parent study (NCT03898167) is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. The three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample HPV testing kits; and 3) telephone recall with mailed self-sample HPV testing kits and patient navigation. A supplemental accrual of Asian/Asian American persons (target n=240) was added to increase representation of this subpopulation in the parent trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Asian ethnicity reported in the electronic health record
- •no history of hysterectomy or cervical cancer
- •no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years
- •patient of Harris Health System in Harris County (Houston), Texas
- •have at least 2 visits to ambulatory care within Harris Health System in the past 5 years
- •be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months
排除标准
- •no valid telephone contact information
- •unable to communicate in English, Vietnamese or Spanish
- •currently pregnant
- •history of cervical dysplasia in the past 3.5 years
研究组 & 干预措施
Telephone Recall
Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System
干预措施: Telephone Recall (Behavioral)
Mailed HPV Self-Sampling Kit
Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a prepaid return envelope
干预措施: Telephone Recall (Behavioral)
Mailed HPV Self-Sampling Kit
Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a prepaid return envelope
干预措施: Mailed HPV Self-Sampling Kit (Behavioral)
Mailed HPV Self-Sampling Kit + Patient Navigation
Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.
干预措施: Telephone Recall (Behavioral)
Mailed HPV Self-Sampling Kit + Patient Navigation
Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.
干预措施: Mailed HPV Self-Sampling Kit (Behavioral)
Mailed HPV Self-Sampling Kit + Patient Navigation
Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.
干预措施: Patient Navigation (Behavioral)
结局指标
主要结局
Primary screening participation
时间窗: [Time Frame: within 6 months of randomization
completion and return of a mailed self-sample HPV testing kit that is adequate for testing (i.e., does not produce unsatisfactory results) or attendance for clinic-based screening
次要结局
- Screening tests results(Time Frame: within 6 months of randomization)
- completion of clinical follow-up among women with an abnormal screening test result(Time Frame: within 12 months of screening test result)
研究者
Jane Montealegre
Associate Professor
M.D. Anderson Cancer Center