A randomized trial of mailed HPV self-sampling for cervical cancer screening among ethnic minority women in South Florida.

PURPOSE: HPV self-sampling has previously been shown to increase cervical cancer screening among ethnic minority and immigrant women. We conducted a randomized pragmatic trial to examine the effectiveness of HPV self-sampling delivered via in-person versus by US mail for medically underserved Hispanic, Haitian, and non-Hispanic Black women living in South Florida. METHODS: We randomized women aged 30-65 who had not completed Pap smear screening in the past 3 years into two groups: (1) HPV self-sampling delivered in-person (IP) by a community health worker (CHW; IP + SS) or (2) HPV self-sampling delivered via US mail (SS + Mail). Our primary outcome was HPV self-sampling completion by 6-month post-study enrollment. RESULTS: We enrolled 600 women. Approximately 65% were Hispanic and 35% were Haitian or non-Hispanic Black. Nearly half (43%) had an income of less than $20,000/year and 67% were uninsured. In intent-to-treat analyses, 71.6% of participants in the SS + Mail group and 81.0% of participants in the IP + SS group completed HPV self-sampling. CONCLUSION: Mailed HPV self-sampling is an effective strategy to increase cervical cancer screening among underserved immigrant and ethnic minority women.

Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial.

BACKGROUND: Underserved ethnic minority women experience significant disparities in cervical cancer incidence and mortality, mainly due to lack of cervical cancer screening. Barriers to Pap smear screening include lack of knowledge, lack of health insurance and access, and cultural beliefs regarding disease prevention. In our previous SUCCESS trial, we demonstrated that HPV self-sampling delivered by a community health worker (CHW) is efficacious in circumventing these barriers. This approach increased screening uptake relative to navigation to Pap smear screening. SUCCESS trial participants, as well as our community partners, provided feedback that women may prefer the HPV self-sampler to be delivered through the mail, such that they would not need to schedule an appointment with the CHW. Thus, our current trial aims to elucidate the efficacy of the HPV self-sampling method when delivered via mail. DESIGN: We are conducting a randomized controlled trial among 600 Haitian, Hispanic, and African-American women from the South Florida communities of Little Haiti, Hialeah, and South Dade. Women between the ages of 30 and 65 years who have not had a Pap smear within the past 3 years are eligible for the study. Women are recruited by CHWs and complete a structured interview to assess multilevel determinants of cervical cancer risk. Women are then randomized to receive HPV self-sampling delivered by either the CHW (group 1) or via mail (group 2). The primary outcome is completion of HPV self-sampling within 6 months post enrollment. DISCUSSION: Our trial is among the first to examine the efficacy of the mailed HPV self-sampling approach. If found to be efficacious, this approach may represent a cost-effective strategy for cervical cancer screening within underserved and underscreened minority groups. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02202109 . Registered on 9 July 2014.

A randomized controlled trial of a faith-placed, lay health advisor delivered smoking cessation intervention for rural residents.

INTRODUCTION: Rural US residents smoke at higher rates than urban or suburban residents. We report results from a community-based smoking cessation intervention in Appalachian Kentucky. STUDY DESIGN: Single-blind, group-randomized trial with outcome measurements at baseline, 17 weeks and 43 weeks. SETTING/PARTICIPANTS: This faith-placed CBPR project was located in six counties of rural Appalachian Kentucky. A total of 590 individual participants clustered in 28 churches were enrolled in the study. INTERVENTION: Local lay health advisors delivered the 12-week Cooper/Clayton Method to Stop Smoking program, leveraging sociocultural factors to improve the cultural salience of the program for Appalachian smokers. Participants met with an interventionist for one 90 min group session once per week incorporating didactic information, group discussion, and nicotine replacement therapy. MAIN OUTCOME MEASURES: The primary outcome was self-reported smoking status. Secondary outcomes included Fagerström nicotine dependence, self-efficacy, and decisional balance. RESULTS: With post-intervention data from 92% of participants, those in intervention group churches (N = 383) had 13.6 times higher odds of reporting quitting smoking one month post-intervention than participants in attention control group churches (N = 154, p < 0.0001). In addition, although only 3.2% of attention control group participants reported quitting during the control period, 15.4% of attention control participants reported quitting smoking after receiving the intervention. A significant dose effect of the 12-session Cooper/Clayton Method was detected: for each additional session completed, the odds of quitting smoking increased by 26%. CONCLUSIONS: The Cooper/Clayton Method, delivered in rural Appalachian churches by lay health advisors, has strong potential to reduce smoking rates and improve individuals' health.