Community-based Clinical Trial Research Articles

Home-based management of severely acute malnutrition: feasibility of ethically designed, community-based randomised clinical trials

The Indian Council of Medical Research had, on May 31, 2011, called for research proposals on severely acute malnourished (SAM) children to generate evidence for the development of practical and scalable regimens to medically rehabilitate children suffering from SAM, without serious complications, at the home/community level and/or peripheral inpatient facilities. The primary outcomes of the proposed research study are recovery from SAM in the short term, as well as sustenance of recovery (for at least six months after the initiation of treatment). The secondary outcomes are the acceptability, feasibility and safety of the regimes being tested. It was suggested that the studies be designed as individual or cluster randomised or quasi randomised controlled trials (RCTs). This paper analyses the methodological, operational, and most importantly, ethical challenges and implications of conducting community-based RCTs involving SAM children. The paper dwells in detail on why and how the RCT design is inappropriate and unsuitable for studying the effectiveness of home-based management of SAM children in the community.

Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial.

BackgroundThe prevalence of osteoarthritis and knee osteoarthritis in the Spanish population is estimated at 17% and 10.2%, respectively. The clinical guidelines concur that the first line treatment for knee osteoarthritis should be non-pharmacological and include weight loss, physical activity and self-management of pain. Health Coaching has been defined as an intervention that facilitates the achievement of health improvement goals, the reduction of unhealthy lifestyles, the improvement of self-management for chronic conditions and quality of life enhancement.The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, pain, overweight and physical activity in patients from 18 primary care centres of Barcelona with knee osteoarthritis.Methods/DesignMethodology from the Medical Research Council on developing complex interventions. Phase 1: Intervention modelling and operationalization through a qualitative, socioconstructivist study using theoretical sampling with 10 in-depth interviews to patients with knee osteoarthritis and 4 discussion groups of 8–12 primary care professionals, evaluated using a sociological discourse analysis. Phase 2: Effectiveness, cost-effectiveness and cost-utility study with a community-based randomized clinical trial. Participants: 360 patients with knee osteoarthritis (180 in each group). Randomization unit: Primary Care Centre. Intervention Group: will receive standard care plus 20-hour health coaching and follow-up sessions. Control Group: will receive standard care. Main Outcome Variable: quality of life as measured by the WOMAC index. Data Analyses: will include standardized response mean and multilevel analysis of repeated measures. Economic analysis: based on cost-effectiveness and cost-utility measures. Phase 3: Evaluation of the intervention programme with a qualitative study. Methodology as in Phase 1.DiscussionIf the analyses show the cost-effectiveness and cost-utility of the intervention the results can be incorporated into the clinical guidelines for the management of knee osteoarthritis in primary care.Trial registrationISRCTN57405925. Registred 20 June 2014.

Knowledge, Awareness, and Interest in Cancer Clinical Trials among Rural Latinos Following Brief Education by Promotores de Salud

Background: Promotores have been widely used for health promotion in underserved Latino communities and are increasingly being partnered with throughout the country to enhance health care access when there are cultural and economic barriers to care. A community network approach using Promotores de Salud may be a useful strategy for increasing overall knowledge and participation of Latinos in clinical trials. Objective: To assess knowledge, attitudes, and interest related to participating in cancer clinical trials among rural Latinos following receipt of a brief community-based cancer research educational session delivered by previously trained promotores de salud. Methods: Trained promotores de salud conducted 10-15 minute one-to-one educational sessions with Latinos. Participants completed a pre-post assessment on knowledge, attitudes and interest in participating in clinical trials. Results: Over a period of two months, five trained promotores recruited and delivered a single educational session with 228 Latinos. At baseline, 68% of participants had heard about clinical trials, but only 5% had participated in one. Compared to baseline, after training, participants increased significantly their positive views of clinical trials, trust in medical researchers, and belief in general safety of clinical research (p<0.001). Interest in participating in cancer clinical trials increased from 68% to 79% (p<.001). Providing bio-specimens for research purposes (p<0.001) also increased significantly. Conclusion: Use of Promotores de Salud to conduct community-based clinical trials education is a promising approach to promote widespread community participation in cancer clinical trials available to ethnic and racial underserved populations.

Effectiveness of tailored lifestyle interventions, using web-based and print-mail, for reducing blood pressure among rural women with prehypertension: main results of the Wellness for Women: DASHing towards Health clinical trial.

BackgroundLifestyle modification is recommended for management of prehypertension, yet finding effective interventions to reach rural women is a public health challenge. This community-based clinical trial compared the effectiveness of standard advice to two multi-component theory-based tailored interventions, using web-based or print-mailed delivery, in reducing blood pressure among rural women, ages 40–69, with prehypertension.Methods289 women with prehypertension enrolled in the Wellness for Women: DASHing towards Health trial, a 12-month intervention with 12-month follow-up. Women were randomly assigned to groups using a 1:2:2 ratio, comparing standard advice (30-minute counseling session) to two interventions (two 2-hour counseling sessions, 5 phone goal-setting sessions, strength-training video, and 16 tailored newsletters, web-based or print-mailed). Linear mixed model methods were used to test planned pairwise comparisons of marginal mean change in blood pressure, healthy eating and activity, adjusted for age and baseline level. General estimating equations were used to examine the proportion of women achieving normotensive status and meeting health outcome criteria for eating and activity.ResultsMean blood pressure reduction ranged from 3.8 (SD = 9.8) mm Hg to 8.1 (SD = 10.4) mm Hg. The 24-month estimated marginal proportions of women achieving normotensive status were 47% for web-based, and 39% for both print-mailed and standard advice groups, with no group differences (p = .11 and p = .09, respectively). Web-based and print-mailed groups improved more than standard advice group for waist circumference (p = .017 and p = .016, respectively); % daily calories from fat (p = .018 and p = .030) and saturated fat (p = .049 and p = .013); daily servings of fruit and vegetables (p = .008 and p < .005); and low fat dairy (p < .001 and p = .002). Greater improvements were observed in web-based versus standard advice groups in systolic blood pressure (p = .048) and estimated VO2max (p = .037). Dropout rates were 6% by 6-months, 11.4% by 24 months, with no differences across groups.ConclusionsRural women with prehypertension receiving distance-delivery theory-based lifestyle modifications can achieve a reduction of blood pressure and attainment of normotensive status.Trial registrationClinicalTrials.gov NCT00580528

A Clinical Overview of Monoamine Oxidase Inhibitors: Pharmacological Profile, Efficacy, Safety/Tolerability, and Strategies for Successful Outcomes in the Management of Major Depressive Disorders

The discovery of monoamine oxidase inhibitors (MAOIs) resulted in their widespread use as first- and second-line treatments for major depressive disorders (MDD) and anxiety for more than 30 years. Newer antidepressant modalities were developed to provide greater efficacy and address the safety concerns of medication and dietary interactions associated with conventional MAOIs. The newer antidepressant treatments, including augmentation, resulted in a significant reduction in the use of, and familiarity with, MAOIs. There is increasing evidence that MAOIs play an important role in the management of MDD, including large, community-based clinical trials in outpatients with MDD that used treatment with MAOIs as a third- or fourth-level treatment after failing to remit with other treatments. The MAOIs are still included among MDD treatment recommendations in internationally recognized guidelines. The introduction of reversible, or selective, MAOIs offers treatment options that reduce safety concerns regarding diet and medication interactions associated with conventional MAOIs, and dietary instructions are less restrictive. MAOIs can be used successfully with a basic review of the pharmacology, dosing strategies, possible side effects and management, safety issues, dietary and medication guidelines, and when to introduce MAOIs in the management of patients with MDD and related disorders. [ Psychiatr Ann . 2014;44(11):513–523.]

Abstract A56: Adaptation of a cancer clinical trials educational program for African Americans and Latinos

Abstract The purpose of this study was to educate Latino and African American urban populations about cancer clinical trials. Compared to whites, both African Americans and Latinos tend to have lower access to cancer treatment and to be diagnosed at advanced stages, trends associated with increased mortality and more difficult treatments. Clinical trials offer the possibility of developing improved treatments and participants may access treatments before they are widely available. Yet, while overall 3-5% of cancer patients participate in clinical trials, a lower proportion of ethnic minorities participate, resulting in limited generalizability of outcome data on the effectiveness of interventions to prevent and control cancer among underrepresented groups, and less access to newer treatments. Previous research has identified barriers to minority participation in clinical research related to scientific literacy (including fear of mistreatment), language, and civic literacy (lack of trust in biomedical systems). This paper describes the adaptation of a community-based cancer clinical trials educational program from the West Coast of the United States to the East Coast. Researchers and program staff from the two sites worked closely together to share materials, including the pre- and post-program questionnaires and the curriculum formatted in PowerPoint. The program curriculum was revised to be consistent with contextual factors, in order to be culturally competent in the adapting region, as follows. Minority cancer clinical trial participants who were representative of local populations were invited to participate in videotaped interviews about their research experiences. Taped segments of local interview subjects were integrated into the presentation, and segments featuring West Coast research participants were removed. The Spanish language in the curriculum was revised to match regional usage of Latino groups dominant in the East Coast region, while attempting to maintain fidelity with the original meaning. Community outreach, program delivery, and data collection methods were revised to be compatible with the capacity of the adapting site, including revising the measures to match Spanish-language changes made in the curriculum and shifting from written questionnaires to Audience Response electronic technology. Every possible effort was made to otherwise maintain fidelity during implementation and measurement. In the data analysis phase, the research staff is sharing syntax for variable recoding and creation, and will discuss and compare findings across both sites. To test the feasibility of the adaptation, a recruitment goal of 120 participants (40 African Americans, 40 English-speaking Latinos, and 40 Spanish speaking Latinos) was planned. To meet our recruitment goals, over all, 143 people attended our replication programs. To measure participant responsiveness, participants were asked to provide open-ended written comments. The vast majority expressed satisfaction with the presentation. The main themes identified from their comments were that the program was interesting, important, and useful, and that they learned something new. Negative feedback regarding the presentation was minor and related to technical difficulties which prolonged the meetings. We discuss the procedures and lessons learned during the adaptation and feasibility testing of this intervention. This study demonstrates that adaptation of a cancer clinical trials education program from one geographic region to another is feasible, and that the process and the initiative benefit from the sharing of materials between multiple sites. These data contribute to the growing literature on dissemination and implementation research in cancer control and prevention. Citation Format: Debra J. Pelto, Georgia Robins Sadler, Ogo Njoku, Maria Carina Rodriguez, Alma Behar, Vanessa L. Malcarne, Lina Jandorf. Adaptation of a cancer clinical trials educational program for African Americans and Latinos. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A56. doi:10.1158/1538-7755.DISP13-A56

NCI Funds Community-Based Trial Network

Abstract The NCI has awarded 53 grants totaling $93 million annually for 5 years to researchers, academic institutions, and oncologists participating in a national community-based clinical trial network aimed at boosting the participation of minority and underserved populations in cancer research.

Prevention of congenital malformations and other adverse pregnancy outcomes with 4.0mg of folic acid: community-based randomized clinical trial in Italy and the Netherlands.

BackgroundIn 2010 a Cochrane review confirmed that folic acid (FA) supplementation prevents the first- and second-time occurrence of neural tube defects (NTDs). At present some evidence from observational studies supports the hypothesis that FA supplementation can reduce the risk of all congenital malformations (CMs) or the risk of a specific and selected group of them, namely cardiac defects and oral clefts. Furthermore, the effects on the prevention of prematurity, foetal growth retardation and pre-eclampsia are unclear.Although the most common recommendation is to take 0.4 mg/day, the problem of the most appropriate dose of FA is still open.The aim of this project is to assess the effect a higher dose of peri-conceptional FA supplementation on reducing the occurrence of all CMs. Other aims include the promotion of pre-conceptional counselling, comparing rates of selected CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age, abruptio placentae.Methods/DesignThis project is a joint effort by research groups in Italy and the Netherlands. Women of childbearing age, who intend to become pregnant within 12 months are eligible for the studies. Women are randomly assigned to receive 4 mg of FA (treatment in study) or 0.4 mg of FA (referent treatment) daily. Information on pregnancy outcomes are derived from women-and-physician information.We foresee to analyze the data considering all the adverse outcomes of pregnancy taken together in a global end point (e.g.: CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age). A total of about 1,000 pregnancies need to be evaluated to detect an absolute reduction of the frequency of 8%. Since the sample size needed for studying outcomes separately is large, this project also promotes an international prospective meta-analysis.DiscussionThe rationale of these randomized clinical trials (RCTs) is the hypothesis that a higher intake of FA is related to a higher risk reduction of NTDs, other CMs and other adverse pregnancy outcomes. Our hope is that these trials will act as catalysers, and lead to other large RCTs studying the effects of this supplementation on CMs and other infant and maternal outcomes.Trial registrationItalian trial: ClinicalTrials.gov Identifier: NCT01244347.Dutch trial: Dutch Trial Register ID: NTR3161.

The Effect of Self-Administered Acupressure on Chronic Pain in Breast Cancer Survivors

The Journal of Alternative and Complementary MedicineVol. 20, No. 5 Oral Abstract Session 14: Clinical Manual TherapiesThe Effect of Self-Administered Acupressure on Chronic Pain in Breast Cancer SurvivorsSuzanna Zick and Richard HarrisSuzanna ZickSearch for more papers by this author and Richard HarrisSearch for more papers by this authorPublished Online:7 May 2014https://doi.org/10.1089/acm.2014.5057.abstractAboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"The Effect of Self-Administered Acupressure on Chronic Pain in Breast Cancer Survivors." The Journal of Alternative and Complementary Medicine, 20(5), p. A23FiguresReferencesRelatedDetailsCited byAcupressure for Cancer-fatigue in Ovarian Cancer Survivor (AcuOva) Study: A community-based clinical trial study protocol examining the impact of self-acupressure on persistent cancer-related fatigue in ovarian cancer survivorsContemporary Clinical Trials, Vol. 107Auricular points acupressure for insulin resistance in overweight/obese women with polycystic ovary syndrome: protocol for a randomised controlled pilot trial28 May 2019 | BMJ Open, Vol. 9, No. 5 Volume 20Issue 5May 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Suzanna Zick and Richard Harris.The Effect of Self-Administered Acupressure on Chronic Pain in Breast Cancer Survivors.The Journal of Alternative and Complementary Medicine.May 2014.A23-A23.http://doi.org/10.1089/acm.2014.5057.abstractPublished in Volume: 20 Issue 5: May 7, 2014PDF download

The Effect of a Community-Based Self-Help Multimodal Behavioral Intervention in Korean American Seniors With High Blood Pressure

Great strides have been made in improving heart health in the United States during the last 2 decades, yet these strides have not encompassed many ethnic minority populations. There are significant health disparity gaps stemming from both a paucity of valid research and a lack of culturally sensitive interventions. In particular, many Korean Americans with chronic illnesses encounter difficulty navigating the healthcare system because of limited health literacy. The effect of a multimodal Self-Help Intervention Program on the Control of High Blood Pressure (HBP) was tested in a community-based clinical trial for Korean American seniors. Of 440 seniors enrolled, 369 completed the study (184 in the intervention group and 185 in the control group; mean age = 70.9±5.3 years). The intervention group received 6 weekly educational sessions on HBP management skill building, including health literacy training, followed by telephone counseling and home blood pressure (BP) monitoring for 12 months. Findings support that the Self-Help Intervention Program on the Control of HBP was effective in controlling BP in this ethnic/linguistic minority population. The BP control rates for the intervention and control groups were 49.5% vs. 43.2% at baseline, 58.5% vs. 42.4% at 6 months, 67.9% vs. 52.5% at 12 months, and 54.3% vs. 53.0% at 18 months. Significant changes were observed over time in some psychobehavioral outcomes, including self-efficacy for BP control, medication adherence behavior, HBP knowledge, and depression. The study findings suggest that the multimodal Self-Help Intervention Program on the Control of HBP is effective at promoting optimal HBP control for this ethnic/linguistic minority population. NCT00406614.

The Impact of a Community-Based Clinical Trial Educational Intervention among Underrepresented Chinese Americans

Clinical trials are a critical resource for the discovery of new prevention, diagnostic, and treatment methods for cancer. The most effective prevention and treatment modalities are based on previous clinical trial results. However, participation in clinical trials is underrepresented by racial/ethnic minority populations, Asian Americans in particular. Asian Americans are the least represented of any ethnic groups in clinical trials. The purpose of this study is to develop and evaluate a culturally and linguistically appropriate community-based educational intervention to increase knowledge of and intent to participate in cancer clinical trials among underrepresented Chinese Americans. Community-Based Participatory Research approach was used to guide the development, cultural tailoring, implementation, and evaluation of clinical trial intervention. First, 22 Asian community representatives were recruited as community health educators (CHE) who received 12-hour training on clinical trial education. Second, 262 members were recruited from 11 Chinese community organizations. Of those recruited, a total of 247 eligible Chinese enrolled and participated in the clinical trial education delivered by trained CHEs. Participants completed pretest before and posttest after the intervention. Fifteen of 21 measures of clinical trial knowledge showed significant changes post the intervention (P < 0.05). Education remained the sole demographic factor increasing clinical trial knowledge in multivariate analysis. Clinical trial education should emphasize both benefits to science and the larger Asian community. This community-based clinical trial intervention demonstrated promising results and has potential to enhance recruitment and participation in clinical trial research among the underrepresented Asian Americans. Improving clinical trial participation in the fast-growing Asian American population is key to dissemination of health innovations targeted to diminish health disparities.

Preventing caries in preschoolers: Successful initiation of an innovative community-based clinical trial in Navajo Nation Head Start

Navajo Nation children have the greatest prevalence of early childhood caries in the United States. This protocol describes an innovative combination of community-based participatory research and clinical trial methods to rigorously test a lay native Community Oral Health Specialists-delivered oral health intervention, with the goal of reducing the progression of disease and improving family knowledge and behaviors. Methods/DesignThis cluster-randomized trial designed by researchers at the Center for Native Oral Health Research at the University of Colorado in conjunction with members of the Navajo Nation community compares outcomes between the manualized 2-year oral health fluoride varnish-oral health promotion intervention and usual care in the community (child–caregiver dyads from 26 Head Start classrooms in each study arm; total of 1016 dyads). Outcome assessment includes annual dental screening and an annual caregiver survey of knowledge, attitudes and behaviors; collection of cost data will support cost–benefit analyses. DiscussionThe study protocol meets all standards required of randomized clinical trials. Aligned with principles of community-based participatory research, extended interaction between members of the Navajo community and researchers preceded study initiation, and collaboration between project staff and a wide variety of community members informed the study design and implementation. We believe that the benefits of adding CBPR methods to those of randomized clinical studies outweigh the barriers and constraints, especially in studies of health disparities and in challenging settings. When done well, this innovative mix of methods will increase the likelihood of valid results that communities can use.

Description of the EUROBIS program: a combination of an Epode community-based and a clinical care intervention to improve the lifestyles of children and adolescents with overweight or obesity.

The present paper describes the Epode Umbria Region Obesity Prevention Study (EUROBIS) and aims to implement the C.U.R.I.A.MO. model through the EPODE methodology. The main goal of the EUROBIS is to change the pendency of slope of the actual trend towards the increase in the yearly rates of childhood overweight and obesity in Umbria and to improve healthy lifestyles of children and their parents. The project is the first EPODE program to be performed in Italy. The aims of the Italian EUROBIS study are: (1) a community-based intervention program (CBP) carrying out activities in all primary schools of the Umbria Region and family settings as first step, to reverse the current obesity trend on a long-term basis, and (2) a clinical care program for childhood and adolescent by C.U.R.I.A.MO. model. C.U.R.I.A.MO. model is a multidisciplinary approach to improve three key aspects of healthy lifestyles: nutrition, exercise, and psychological aspects with the strategy of a family-based approach. The community-based intervention and clinical trial provide an innovative valuable model to address the childhood obesity prevention and treatment in Italy.

Abstract 294: Community-Based, Targeted CPR Education to Improve Survival From Out-of-Hospital Cardiac Arrest in High-Risk Neighborhoods

Background: High-risk neighborhoods, defined as having a low prevalence of bystander CPR and high incidence of out-of-hospital cardiac arrest (OHCA), may be targets for community-based interventions. The HANDDS Program(identifying H igh A rrest N eighborhoods to D ecrease D isparities in S urvival) is a novel intervention to target these neighborhoods to increase CPR awareness. Objective: Conduct a community-based clinical trial in Denver’s high-risk neighborhoods. Methods Population: Convenience sample of 344 participants recruited from target neighborhoods during 12-week study period. Intervention: Participants completed a pre-test survey to assess baseline knowledge of CPR. A group hands-only CPR training lasting 1 hour was conducted with the CPR Anytime kit, which includes an educational DVD and hands-on practical skills training. Participants then completed a survey to assess their post-training knowledge and were asked to use the kits to train others. A $10 incentive was given to participants. Two-sample t -tests were conducted to assess for differences in CPR knowledge pre- and post training. Results: Participants were Asian (50.0%), Black (35.6%), female (68.0%), had completed high school (26.8%), and had an annual income of less than $30,000 (37.1%). After the CPR intervention, the mean number of questions answered correctly on CPR knowledge increased ( Table 1): Majority of participants (84.6%) felt comfortable performing hands-only CPR after the intervention. Information was returned by 154 (44.8%) participants, with an additional 836 friends and family trained. Conclusion: A total of 1180 people were trained in hands-only CPR (average 3.43 people/kit). At $35 per CPR Anytime kit, this comes to a cost $10.20 for each person trained. Participants demonstrated increased knowledge of CPR and enthusiasm to train others. The HANDDS Program is a feasible method for increasing bystander CPR training in high-risk neighborhoods.

Vitamin C supplementation protect from adverse effects of perfluorinated compounds on insulin resistance in the elderly: Community-based clinical trial

Backgrounds. Perfluorinated compounds (PFCs) are persistent organic pollutants which exhibit hormone disturbances in addition to hepatotoxicity, immunotoxicity, developmental toxicity, and tumorigenic potential. Aims. Whether PFCs affect insulin resistance (IR) and vitamin C intake protects against the adverse effect of PFCs was estimated. Methods. We designed a cross-over intervention study and assigned 141 elderly subjects aged ?60 either to vitamin C or placebo treatment for 4 weeks in a random order. A 2-week washout period was implemented between the interventions. We measured serum levels of PFCs to estimate PFC exposures and urinary levels of MDA and 8-OHdG for oxidative stress. We also measured levels of fasting glucose and insulin and derived the homeostatic model assessment (HOMA) index to assess IR. Results. In 126 participants without a history of diabetes, PFOS and PFDoDA levels were found to be positively associated with HOMA index at the baseline and after placebo treatment (PPFOS=0.053 and PPFDoDA=0.01). Risks of IR determined as HOMA ? 2.5 for the top decile of PFOS and PFDoDA exposures were significantly elevated compared with those of less than top decile exposures (ORPFOS=2.2, PPFOS&lt;0.0001; and ORPFDoDA=3.3, PPFDoDA&lt;0.0001). However, the effects of PFOS and PFDoDA on HOMA were disappeared after vitamin C supplementation. Furthermore, at the baseline and after placebo treatment, PFOS and PFDoDA levels were also significantly associated with MDA (PPFOS=0.02) and 8-OHdG levels (PPFOS=0.001 and PPFDoDA=0.01) and MDA levels were positively associated with HOMA index (P=0.03). Conclusions. In the elderly without a history of diabetes, PFOS and PFDoDA exposures were positively associated with IR and vitamin C supplementation protects against the adverse effect of PFOS and PFDoDA.

Cognitive mapping: using local knowledge for planning health research

BackgroundCognitive mapping is a participatory research methodology that documents, in visual form, a construct of the local environment in which people live and work. We adapted this method to provide detailed data about study locales to inform recruitment and retention strategies for HIV prevention community based clinical trials.MethodsFour cognitive mapping studies were undertaken between 2005 and 2010, in and around Johannesburg in Orange Farm, and Hillbrow. Participants included members of clinical trial Community Advisory Boards (CAB), young people recruited from schools in Hillbrow and an organization for out of school youth, and men recruited from a database of men in the community interested in taking part in research. These groups participated in reconnaissance walks and in depth interviews, and drew detailed sketch maps.ResultsThe cognitive maps defined the physical boundaries of the research locales, provided insights into their social histories, and identified important characteristics of the population such as movement, social and sexual networks, ethnic and other divisions. Important differences between the official cartographic maps and the cognitive maps were raised. The mapping data was applied by identifying key areas for recruitment that recruitment staff members were less familiar with and that may otherwise have been overlooked.ConclusionsCognitive mapping is an effective, rapid and low cost method that can be used to inform recruitment and retention strategies for community-based clinical trial research. The method also provides a means for clinical trial researchers to involve the local community in research and to familiarise them with the social setting.

Retention in methadone and buprenorphine treatment among African Americans

Methadone has been the most commonly used pharmacotherapy for the treatment of opioid dependence in U.S. public sector treatment, but availability of buprenorphine as an alternative medication continues to increase. Drawing data from two community-based clinical trials that were conducted nearly contemporaneously, this study examined retention in methadone versus buprenorphine treatment over 6months among urban African Americans receiving treatment in one of four publicly-funded programs (N=478; 178 methadone; 300 buprenorphine). Adjusting for confounds related to medication selection, survival analysis revealed that buprenorphine patients are at substantially higher risk of dropout compared to methadone patients (HR=2.43; p<.001). Buprenorphine's retention disadvantage appears to be concentrated in the earlier phases of treatment (approximately the first 50days), after which risk of subsequent dropout becomes similar for the two medications. These findings confirm a retention disparity between methadone and buprenorphine in this population, and suggest potential avenues for future research to enhance retention in buprenorphine treatment.

High effectiveness of peginterferon alfa-2a plus ribavirin therapy in Korean patients with chronic hepatitis C in clinical practice

Background/AimsIdentifying the impact of a patient's ethnicity on treatment responses in clinical practice may assist in providing individualized treatment regimens for chronic hepatitis C (CHC). The effectiveness of standard peginterferon plus ribavirin therapy and the need for triple combination therapy with protease inhibitors in Koreans remain matters of debate. These issues were investigated in the present study.MethodsThe clinical data of 272 treatment-naïve Korean CHC patients who were treated in a community-based clinical trial (Clinical Trial group; n=51) and in clinical practice (Cohort group; n=221), were analyzed and compared. All were treated with standard protocols of peginterferon alfa-2a plus ribavirin therapy.ResultsFor patients with hepatitis C virus (HCV) genotype 1, the sustained virological response (SVR) rates in the Clinical Trial and Cohort groups were 81% (21/26) and 55% (58/106), respectively, by intention-to-treat (ITT) analysis (P=0.02), and 100% (13/13) and 80% (32/40), respectively, in treatment-adherent patients (P=0.18). For patients with HCV genotype 2, the SVR rates in these two groups were 96% (24/25) and 88% (101/115), respectively, by ITT analysis (P=0.31). Adherence and treatment duration were independent predictors of SVR for genotypes 1 and 2, respectively (P<0.01 for each). Korean patients with CHC achieved high SVR rates with peginterferon alfa-2a plus ribavirin in both the clinical trial and clinical practice settings.ConclusionsMeasures to raise adherence to standard therapy in clinical practice may improve the SVR rates in these patients as effectively as adding protease inhibitors, thus obviating the need for the latter.

ASSOCIATIONS OF CARDIORESPIRATORY FITNESS AND FATNESS WITH METABOLIC SYNDROME IN RURAL WOMEN WITH PREHYPERTENSION

Background. This study investigated the associations of fitness and fatness with metabolic syndrome in rural women, part of a recognized US health disparities group. Methods. Fitness, percentage body fat, BMI, and metabolic syndrome criteria were assessed at baseline in 289 rural women with prehypertension, ages 40–69, enrolled in a healthy eating and activity community-based clinical trial for reducing blood pressure. Results. Ninety (31%) women had metabolic syndrome, of which 70% were obese by BMI (≥30 kg/m2), 100% by percentage body fat (≥30%), and 100% by revised BMI standards (≥25 kg/m2) cited in current literature. Hierarchical logistic regression models, adjusted for age, income, and education, revealed that higher percentage body fat (P < 0.001) was associated with greater prevalence of metabolic syndrome. Alone, higher fitness lowered the odds of metabolic syndrome by 7% (P < 0.001), but it did not lower the odds significantly beyond the effects of body fat. When dichotomized into “fit” and “unfit” groups, women categorized as “fat” had lower odds of metabolic syndrome if they were “fit” by 75% and 59%, for percentage body fat and revised BMI, respectively. Conclusion. Among rural women with prehypertension, obesity and fitness were associated with metabolic syndrome. Obesity defined as ≥25 kg/m2 produced results more consistent with percentage body fat as compared to the ≥30 kg/m2 definition.

Abstract PL05-01: Cervical cancer as an example of gender-associated health inequality.

Abstract Latin America has experienced important improvements in socio-economic and health indicators in the last few decades. Between 1960 and 2000, per capita income doubled, life expectancy increased from 57 to 70 years and infant mortality decreased from 97 to 27/1000 children born alive (1). However, the region, together with sub Saharan Africa, is the most unequal in the world (2) and the benefits of the improved indicators are only reaching a subset of the population. In this context, it is no surprise that cervical cancer, that characteristically affects poor women without access to medical care, continues to be one of the leading public health problems in the region as it is in most developing areas. Almost 90% of cervical cancer occurs in developing regions, and remarkable geographical differences are present even in low-incidence countries, where the most disadvantaged segments of the population are still at high risk of this disease. Efforts to control cervical cancer have been largely unsuccessful in developing regions, in part because the preventive interventions of the past were very limited and complex. Programs based on cytology screening, despite their success in cervical cancer control in high income countries, have been very difficult to implement, in part because of the limitations of the technique (low sensitivity, need for quality control) and in part because of the multiple visits required when the test is positive (screening, colposcopy, treatment), which involve ample coordination between multiple instances within the health system, with the corresponding high cost. The new options available for primary and secondary prevention offer an excellent opportunity to intervene more effectively. Vaccination of adolescent women promises significant reduction in the burden of disease within several decades, and the new screening methodologies available represent an improvement in multiple aspects of the process, but require active and decisive efforts of scientists, activists and the health system for their implementation in organized national programs. The production of new knowledge about cervical cancer and the development of new preventive methods have had the unprecedented participation of multiple research centers in Latin America, as well as many thousands of study participants from the region who have generously contributed. The more than 25 years collaboration between the US National Cancer Institute and Costa Rican researchers to investigate multiple aspects of the natural history of HPV and associated neoplasia (3-8) including the evaluation of an HPV vaccine in a large randomized clinical trial, is an example of the potential of multinational collaboration. The extensive technology transfer associated with this effort has likely contributed to an important decline in cervical cancer mortality in Costa Rica HPV vaccination of young women is advancing rapidly in the region, and organized screening programs based on HPV testing and incorporating innovative strategies, are starting with the leadership of Mexico, Argentina and Colombia. Many questions remain unanswered, including how to manage HPV positive women and its associated psychosocial issues, but we are at the threshold of a new era where the terrible suffering imposed by cervical cancer on Latin American families will be a thing of the past.