Recruitment and retention strategies in a clinical trial for children with chronic hepatitis C infection.

Successful strategies for recruitment and retention (R & R) in pediatric trials are needed. The purpose of our study was to analyze the effectiveness of R&R in a trial for children with hepatitis C. Recruitment strategies were (1) Initial (months 0-12) and (2) extra effort (months 13-18). Initial strategies enrolled 70/114 (61%) of patients. Extra effort strategies included: (1) radio broadcasts, (2) contact with adult hepatologists, (3) dissemination of study material and (4) modification of the exclusion criteria. The overall retention rate was 84% at 2 years. Lessons learned will be valuable in designing future pediatric trials.

Seroprevalence of HCV infection in homeless Baltimore families.

Our objective was to investigate hepatitis C virus (HCV) seroprevalence in homeless caregivers and their children 2-18 years of age living in a family. During a 30-month period from October 2001 through April 2004 in Baltimore, 170 caregivers enrolled and 168 of these accepted testing for antibody to HCV (anti-HCV), as did all 336 children and adolescents enrolled. Main results. None of the children younger than 18 years old were HCV seropositive; in striking contrast, however, 32 (19%) caregivers were seropositive. Most (59%) were previously unaware of their HCV serostatus. History of ever injecting drugs was the strongest predictor of HCV seropositive status in the caregivers, reported by 14% overall, and by 71% of HCV positives. Conclusion. The homeless families were very receptive to our HCV seroprevalence study and are likely also to be receptive to shelter-based HCV prevention programs for young children and adolescents as well as for adults.

High prevalence of overweight and obesity in homeless Baltimore children and their caregivers: a pilot study.

CONTEXT: In the past, nutritional deficiencies were common among homeless families. Because obesity is currently a major public health issue in the United States, it is possible that obesity has supplanted nutritional deficiencies as the "new malnutrition" of the homeless. OBJECTIVE: To perform a pilot study to determine the nutritional status of homeless caregivers and their children in the Baltimore City, Maryland. DESIGN: Determination of weight, height, and body mass index (BMI) (weight in kg/height in m2) of all subjects and correlation with demographic variables. SETTING: Six homeless shelters and transitional houses in Baltimore City. PATIENTS: Thirty-one caregivers and 60 children. MAIN OUTCOME MEASURES: Relationship between caregiver BMI and child BMI and comparison of our data to National Health and Nutrition Examination Survey (NHANES) norms. RESULTS: Forty-two percent of the children (25 of 60) had a BMI-for-age classifying them as at risk for overweight (18%) or overweight (23%). None were underweight. One hundred percent of girls and 88% of boys under age 7 years were in the normal range for BMI. There were no caregivers in the underweight range for BMI. Seventy-seven percent were either overweight (26%) or obese (51%). When the weight categories of the largely African-American homeless Baltimore caregivers and their children were compared with national data from NHANES 1999-2002 for both African-American poor and nonpoor adult females and children, the Baltimore subjects had the lowest proportion in the healthy range and the highest proportion in the obese (adults) and overweight (children) categories. Caregiver BMI correlated with child BMI: r = 0.43, P = .0002. CONCLUSION: Our data suggest that overweight and obesity are the major forms of malnutrition in homeless families.

Positive impact of a shelter-based hepatitis B vaccine program in homeless Baltimore children and adolescents.

Homeless youth are at increased risk for hepatitis B virus (HBV) infection and HBV vaccine coverage is poor in this group. The purpose of our study was to determine if a shelter-based HBV vaccine program in children and adolescents 2-18 years of age with a randomized controlled trial using a culturally appropriate HBV video could increase HBV vaccine coverage rates. Subjects were randomized to an 8 min HBV video or a control, smoking prevention video. Before exposure to the videos, HBV knowledge, and demographics were assessed in caregivers and adolescents. HBV vaccine no. 1 was offered to all subjects who did not produce a vaccine record; subsequently, an accurate HBV vaccine history was obtained from medical providers. Subjects were asked to return 1 and 3 months after visit 1, HBV vaccine was offered to all with incomplete coverage, and HBV knowledge was reassessed. There were 328 children and adolescents cared for by 170 caregivers enrolled in the study. One hundred and four had incomplete HBV vaccine coverage. Data are reported for all family units with at least one subject needing vaccine. There were 53 children and adolescents randomized to the HBV video vs. 51 to the smoking video. HBV knowledge scores of caregivers improved at Visit no. 2 vs. no. 1 in the HBV video group (p = 0.01) but not in the smoking group (p = 0.82). Similar results were observed for adolescents in the HBV video group (p = 0.05) but not in the smoking group (p = 0.40). Exposure to the HBV video vs the smoking video had a significant effect on return rates for vaccine at Visit no. 2 (59 vs. 31%; p = 0.05) but not at Visit no. 3 (47 vs. 18%, p = 0.06). The shelter-based vaccine program was very effective in increasing HBV coverage rates in the entire group of 328 children and adolescents enrolled in the study, from 68% coverage at baseline to 85% at the conclusion of the study. We conclude that shelter-based HBV vaccine programs can be highly effective in increasing vaccine coverage rates in older children and adolescents. A brief exposure to a culturally appropriate HBV video improves HBV knowledge and may improve return rates for vaccine.