Increasing uptake of evidence-based screening services though a community health worker-delivered multimodality program: study protocol for a randomized pragmatic trial.

BACKGROUND: Underserved ethnic minority populations experience significant disparities in HIV, hepatitis C virus (HCV), colorectal cancer (CRC), and cervical cancer incidence and mortality. Much of the excess burden of these diseases among underserved communities is due to lack of preventive care, including screening. Barriers to disease screening include low awareness, lack of access to care and health insurance, and cultural beliefs regarding disease prevention. Our current trial aims to examine community health worker (CHW)-delivered, home-based multi-modality screening for HIV, HCV, CRC, and cervical cancer simultaneously. DESIGN: We are conducting a randomized pragmatic trial among 900 Haitian, Hispanic, and African-American participants from diverse underserved communities in South Florida. People between the ages of 50 and 65 who have not had appropriate HIV, HCV, CRC, and cervical cancer screening per United States Preventive Services Task Force (USPSTF) recommendations are eligible for the study. Participants are recruited by CHWs and complete a structured interview to assess multilevel determinants of disease risk. Participants are then randomized to receive HIV, HCV, CRC, and cervical cancer screening via navigation to care by a CHW (Group 1) or via CHW-delivered home-based screening (Group 2). The primary outcome is completion of screening for each of these diseases within 6 months post-enrollment. DISCUSSION: Our trial is among the first to examine the effectiveness of a CHW-delivered, multimodality, home-based disease-screening approach. If found to be effective, this approach may represent a cost-effective strategy for disease screening within underserved and underscreened minority groups. TRIAL REGISTRATION: Clinical Trials.gov # NCT02970136, registered November 21, 2016.

Implementing Two Randomized Pragmatic Trials of HPV Self-sampling among Underserved Women: Challenges and Lessons Learned.

BACKGROUND: Haitian and Hispanic immigrant women experience substantial disparities in cervical cancer screening. Recently, our team completed two randomized trials of human papillomavirus (HPV) self-sampling as a cervical cancer screening strategy among Haitian and Hispanic women, using a community-based participatory research (CBPR) approach. OBJECTIVE: To reflect on lessons learned in the process of completing two large randomized cancer screening trials within underserved communities. METHODS: Haitian and Hispanic women were randomized to HPV self-sampling versus navigation to Pap smear versus standard cervical cancer screening education in the first trial, and HPV self-sampling delivered in-person versus via mail in the second trial. LESSONS LEARNED: During the two trials, our team encountered several challenges. The lessons learned from these challenges allowed for the strengthening of our community partnerships, study procedures, and our ability to conduct CBPR within an academic setting. CONCLUSIONS: Lessons learned from our trials may be useful to other researchers engaging in CBPR within underserved communities.

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.

HPV Self-Sampling for Cervical Cancer Screening Among Ethnic Minority Women in South Florida: a Randomized Trial.

BACKGROUND: Ethnic minority women are at increased risk of cervical cancer. Self-sampling for high-risk human papillomavirus (HPV) is a promising approach to increase cervical screening among hard-to-reach populations. OBJECTIVE: To compare a community health worker (CHW)-led HPV self-sampling intervention with standard cervical cancer screening approaches. DESIGN: A 26-week single-blind randomized pragmatic clinical trial. PARTICIPANTS: From October 6, 2011 to July 7, 2014, a total of 601 Black, Haitian, and Hispanic women aged 30-65 years in need of cervical cancer screening were recruited, 479 of whom completed study follow-up. INTERVENTIONS: Participants were randomized into three groups: (1) outreach by CHWs and provision of culturally tailored cervical cancer screening information (outreach), (2) individualized CHW-led education and navigation to local health care facilities for Pap smear (navigation), or (3) individualized CHW-led education with a choice of HPV self-sampling or CHW-facilitated navigation to Pap smear (self-swab option). MAIN MEASURES: The proportion of women in each group whom self-reported completion of cervical cancer screening. Women lost to follow-up were considered as not having been screened. KEY RESULTS: Of the 601 women enrolled, 355 (59%) were Hispanic, 210 (35%) were Haitian, and 36 (6%) were non-Haitian Black. In intent-to-treat analyses, 160 of 207 (77%) of women in the self-swab option group completed cervical cancer screening versus 57 of 182 (31%) in the outreach group (aOR 95% CI, p < 0.01) and 90 of 212 (43%) in the navigation group (aOR CI, p = 0.02). CONCLUSIONS: As compared to more traditional approaches, CHW-facilitated HPV self-sampling led to increased cervical cancer screening among ethnic minority women in South Florida. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02121548.

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.

Get Vaccinated! and Get Tested! Developing Primary and Secondary Cervical Cancer Prevention Videos for a Haitian Kreyòl-Speaking Audience.

Although routine screening reduces cervical cancer rates between 60% and 90%, thousands of women worldwide are diagnosed with the disease on an annual basis because of inadequate screening. Haitian women in South Florida experience a disproportionate burden of cervical cancer, with disease rates 4 times higher than the average for women in Miami. An ongoing community-based participatory research initiative to assess and reduce this burden has revealed that a complex interplay of factors contributes to a lack of access to screening in this community, including socioeconomics, language barriers, and traditional understandings of health and disease. In an effort to address some of these barriers and encourage uptake of primary and secondary cervical cancer prevention strategies, 2 videos on cervical cancer prevention were created using a community-based participatory research framework. The video screenplays were created by a Haitian screenwriter using evidence-based medical information provided by academic researchers. The films feature Haitian actors speaking a Haitian Kreyòl dialogue with a storyline portraying friends and family discussing human papillomavirus disease and vaccination, Papanicolaou testing, and cervical cancer. Focus groups held with Haitian women in South Florida suggested that the films are engaging; feature relatable characters; and impact knowledge about human papillomavirus, cervical cancer development, and current prevention recommendations.

Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial.

BACKGROUND: In the United States certain minority groups, such as racial/ethnic immigrant women, are less likely than non-Hispanic White women to be screened for cervical cancer. Barriers to such care include health insurance, cost, knowledge, attitudes, health literacy, and cultural norms and practices. Among the most promising approaches to increase screening in these groups are patient navigators that can link women to sources of appropriate care. Another recent promising approach is using human papilloma virus (HPV) self-sampling. In this manuscript, we describe our National Cancer Institute-sponsored study testing such approaches among immigrant minority women. DESIGN: The South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS) is conducting a three-arm randomized trial among Hispanic, Haitian, and African American women in Miami-Dade County. Community health workers (CHW) based in each of three communities are recruiting 200 women at each site (600 total). Eligibility criteria include women aged 30-65 years who have not had a Pap smear test in the last 3 years. Prior to randomization, all women undergo a standardized structured interview. Women randomized to public health outreach, Group 1, receive culturally tailored educational materials. Women in Group 2 receive an individualized comprehensive cervical cancer CHW-led education session followed by patient navigation to obtain the Pap smear test at community-based facilities. Women in Group 3 have the option of navigation to a Pap smear test or performing HPV self-sampling. The primary outcome is self-report of completed screening through a Pap smear test or HPV self-sampling within 6 months after enrollment. DISCUSSION: SUCCESS is one of the first trials testing HPV self-sampling as a screening strategy among underserved minority women. If successful, HPV self-sampling may be an important option in community outreach programs aimed at reducing disparities in cervical cancer. TRIAL REGISTRATION: Clinical Trials.gov # NCT02121548, registered April 21, 2014.