Community Health Workers, Access to Care, and Service Utilization Among Florida Latinos: A Randomized Controlled Trial.

OBJECTIVES: To determine whether a 1-year community health worker intervention improves access to care and service utilization among Latinos with diabetes. METHODS: We conducted a single-blind randomized trial of 300 adults with poorly controlled diabetes treated in 2 public hospital clinics in Miami, Florida. We began enrollment in 2010 and completed follow-up in 2015. We examined access and utilization using self-reported measures and data from electronic medical records. RESULTS: Participants randomized to the community health worker intervention self-reported fewer problems accessing needed care and prescriptions than did those in the usual care group (30% vs 43% and 28% vs 41%, respectively; P < .05 for both). Adjusting for age, gender, education, depression, and comorbidities showed similar results (odds ratio [OR] = 0.52; 95% confidence interval [CI] = 0.29, 0.93 and OR = 0.45; CI = 0.24, 0.82, respectively). We found no significant utilization differences in primary care visits, emergency department utilization, or hospitalization between the 2 groups. CONCLUSIONS: Among Latinos with poorly controlled diabetes, a 1-year community health worker intervention was associated with improvements in self-reported access to care but not service utilization.

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.

Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial.

Importance: Community health worker (CHW) intervention is a promising approach to address type 2 diabetes among Latinos. However, evidence from randomized clinical studies is limited. Objective: To compare a CHW intervention with enhanced usual care. Design, Setting, and Participants: This 52-week, single-blind, randomized clinical trial included 300 Latino adults aged 18 to 65 years who were treated in 2 public hospital outpatient clinics in Miami-Dade County, Florida, from July 1, 2010, through October 31, 2013. Eligible participants had a hemoglobin A1c (HbA1c) level of 8.0 or greater. Follow-up was completed January 31, 2015, and data were analyzed from March 10, 2015, to June 6, 2016. Interventions: A 1-year CHW intervention consisted of home visits, telephone calls, and group-level activities. Main Outcomes and Measures: Primary outcomes included systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDLC) levels, and HbA1c levels. Secondary outcomes included body mass index, medication regimen intensification, and self-reported measures of diet, physical activity, and medication regimen adherence. Results: Of the 300 participants randomized (135 men [45%] and 165 women [55%]; mean [SD] age, 55.2 [7.0] years), we obtained follow-up data on 215 (71.7%). Participants in the CHW group received a median of 4 home visits and 20 telephone calls. After adjusting for baseline values and covariates, participants in the CHW group had an HbA1c level that was 0.51% lower (95% CI, -0.94% to -0.08%) than that of participants in the enhanced usual care group. The reduction in SBP of 4.62 mm Hg (95% CI, -9.01 to -0.24 mm Hg) did not meet the preplanned target of 8 mm Hg and was not statistically significant in unadjusted models. No significant differences in LDLC levels (mean difference, -8.2 mg/dL; 95% CI, -18.8 to 2.3 mg/dL) or any of the preplanned secondary outcomes were observed. Post hoc analyses suggest that the intervention may be more beneficial among those with worse control of their type 2 diabetes at baseline. Conclusions and Relevance: Among Latinos with poorly controlled type 2 diabetes, a 12-month CHW intervention lowered HbA1c levels by 0.51%. The intervention did not lead to improvements in LDLC levels, and the findings with respect to SBP were variable and half of what was targeted. Future studies should examine whether CHW interventions affect other measures, such as access to health care or social determinants of health. Trial Registration: clinicaltrials.gov Identifier: NCT01152957.

Acceptability and Feasibility of Human Papilloma Virus Self-Sampling for Cervical Cancer Screening.

OBJECTIVES: Women in safety-net institutions are less likely to receive cervical cancer screening. Human papilloma virus (HPV) self-sampling is an alternative method of cervical cancer screening. We examine the acceptability and feasibility of HPV self-sampling among patients and clinic staff in two safety-net clinics in Miami. MATERIALS AND METHODS: Haitian and Latina women aged 30-65 years with no Pap smear in the past 3 years were recruited. Women were offered HPV self-sampling or traditional Pap smear screening. The acceptability of HPV self-sampling among patients and clinic staff was assessed. If traditional screening was preferred the medical record was reviewed. RESULTS: A total of 180 women were recruited (134 Latinas and 46 Haitian). HPV self-sampling was selected by 67% women. Among those selecting traditional screening, 22% were not screened 5 months postrecruitment. Over 80% of women agreed HPV self-sampling was faster, more private, easy to use, and would prefer to use again. Among clinic staff, 80% agreed they would be willing to incorporate HPV self-sampling into practice. CONCLUSIONS: HPV self-sampling was both acceptable and feasible to participants and clinic staff and may help overcome barriers to screening.

A profile of Latinos with poorly controlled diabetes in South Florida.

INTRODUCTION: Latinos are the largest minority group in the United States and diabetes or pre-diabetes affects more than 70% of Latinos aged 45 years and older. Miami-Dade County is home to one of the highest populations of diverse Latinos. In this descriptive manuscript, we present baseline characteristics of participants enrolled in the Miami Healthy Heart Initiative (MHHI). This was a study conducted to determine the effects of a community health worker (CHW) intervention among Latinos with poorly controlled diabetes in South Florida. METHODS: We recruited 300 diverse Latino adults with suboptimal diabetes outcomes (HbA1c≥8) into MHHI. This randomized control trial examined the impact of a 1-year CHW-led intervention on glycemic control, blood pressure, and cholesterol levels. At baseline, physiologic measures, including HbA1c, LDL, blood pressure, and BMI, were assessed. Data on socio-demographic characteristics and additional determinants of health such as depression status, provider communication, diet, exercise, cigarette smoking, readiness to change diabetes management behaviors (stages of change), and confidence in ability to improve diabetes self-care (self-efficacy) were collected. RESULTS: Participants came from 20 different countries, with Cuban Americans representing 38% of the sample. Most had lived in the US for more than 10 years, had completed at least 12 years of school, and had high levels of health literacy, yet 48% had very low acculturation. Nearly 80% had poor self-efficacy, 80% met the criteria for depression, and 83% were not adherent to their medications. More than half the population was not at their target for blood pressure, 50% were above the recommended LDL goal, and most were obese. CONCLUSION: In a diverse population of Latinos with poorly controlled diabetes in Miami, we found high rates of depression, obesity, medication non-adherence, poor self-efficacy, and provider communication. These may contribute to poor diabetes control, high blood pressure, and elevated cholesterol.

Is greater acculturation associated with an increased prevalence of cardiovascular risk factors among Latinos in South Florida?

OBJECTIVE: To examine the association of acculturation with various cardiovascular risk factors (CRFs) among Latinos with diabetes in South Florida. METHODS: In a cross-sectional analysis of data collected from 300 Latinos with poorly controlled diabetes we measured acculturation using the Marin Short Acculturation Scale. We examined correlations between acculturation and the following 7 CRFs: hemoglobin A1C, low-density lipoprotein, systolic blood pressure, body mass index, smoking status, physical activity, and fruit and vegetable intake. RESULTS: Cubans made up 38% of our population; no other Latino subgroup represented over 17% of the sample. Of the 8 outcomes examined, only smoking was associated with increased acculturation; 12% of Latinos in the 2 lowest acculturation groups were current smokers versus 25% in the highest acculturation group (P=0.02). Furthermore, Cuban Americans from our sample had over double the prevalence of smoking compared with non-Cubans in both the lowest and highest acculturation groups. CONCLUSIONS: With the exception of smoking, our data does not support a link between increased acculturation and higher prevalence of CRFs in Latinos with diabetes. Smoking prevention and cessation programs targeting Latinos and particularly among Cubans are needed.

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.

Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes.

BACKGROUND: Type 2 diabetes mellitus disproportionately affects the Latino community. Latinos with diabetes are also less likely to have adequate control of cardiovascular risk factors such as cholesterol and blood pressure. Community health workers (CHWs) are increasingly being used to address various health disparity conditions, including diabetes. However, evidence of their effectiveness from randomized controlled trials is limited. METHODS: The Miami Health Heart Initiative is a randomized controlled trial of 300 Latino patients with diabetes. Patients with hemoglobin A1c (HbA1c) ≥8.0% were recruited from Miami-Dade's public hospital system. At baseline, all patients underwent phlebotomy, physical examination, and a structured 90-minute research interview. They were then randomized to either usual care or a CHW intervention called Cariño. For participants in the Cariño arm of the study, CHW services included assistance with nonmedical social services, health education, and patient navigation in which the CHWs serve as a bridge between patients and the health care system. These services were delivered through home visits, phone calls, and group visits. At 12 months, all subjects had a follow-up examination. The primary outcomes at 1 year are changes in systolic blood pressure, low-density lipoprotein, and HbA1c. Secondary outcomes include medication adherence, medication intensification, diabetes self-efficacy, physical activity, and self-reported fruit and vegetable intake. DISCUSSION: The Miami Healthy Heart Initiative is one of the first rigorously conducted randomized controlled trials to provide evidence on the impact of CHWs on diabetes intermediate outcomes among Latinos. If the data support our primary hypotheses, the study would lend added support to ongoing efforts to incorporate CHWs as part of our national efforts to reduce and ultimately eliminate health disparities.