***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background Medical research must involve the participation of human subjects . Knowledge of patients ' perspectives and concerns with their involvement in research would enhance recruitment efforts , improve the informed consent process , and enhance the overall trust between patients and investigators . Several studies have examined the views of patients from Western countries . There is limited empirical research involving the perspectives of individuals from developing countries . The purpose of this study is to examine the attitudes of Egyptian individuals toward medical research . Such information would help clarify the type and extent of concerns regarding research participation of individuals from cultural , economic , and political background s that differ from those in developed countries . Methods We conducted semi-structured interviews with 15 Egyptian individuals recruited from the outpatient setting s ( public and private ) at Ain Shams University in Cairo , Egypt . Interviews were taped , transcribed , and translated . Thematic analysis followed . Results All individuals valued the importance of medical research ; however most would not participate in research that involved more than minimal risk . Individuals were comfortable with studies involving surveys and blood sampling , but many viewed drug trials as being too risky . All participants valued the concept of informed consent , as they thought that their permission to be in a research study was paramount . Many participants had discomfort with or difficulty in the underst and ing several research concepts : r and omization , double-blind , and clinical equipoise . Trust in the physicians performing research was important in deciding to participate in clinical research . The small sample size and the selection bias associated with obtaining information from only those who agreed to participate in a research study represent limitations in this study . Conclusion Overall , individuals in our sample recognize the value of medical research and have a great deal of trust regarding medical research and their participation in research . There were , however , concerns with the level of research risks associated with several types of medical research . Many also demonstrated confusion with certain research method ologies . We recommend 1 ) enhanced educational efforts regarding general research concepts to enhance the validity of informed consent and 2 ) further survey studies in other areas of Egypt to determine the generalizability of our results Introduction HIV epidemics in sub-Saharan Africa are generalized , but high-risk subgroups exist within these epidemics . A recent study among fisher-folk communities ( FFC ) in Ug and a showed high HIV prevalence ( 28.8 % ) and incidence ( 4.9/100 person-years ) . However , those findings may not reflect population -wide HIV rates in FFC since the study population was selected for high-risk behaviour . Methods Between September 2011 and March 2013 , we conducted a community-based cohort study to determine the population representative HIV rates and willingness to participate ( WTP ) in hypothetical vaccine trials among FFC , Ug and a. At baseline ( September 2011–January 2012 ) , a household enumeration census was done in eight fishing communities ( one lakeshore and seven isl and s ) , after which a r and om sample of 2200 participants aged 18–49 years was selected from 5360 individuals .  Interviewer-administered question naire data were collected on  HIV risk behaviours and WTP , and venous blood was collected for HIV testing using rapid HIV tests with enzyme-linked immunosorbent assay ( EIA ) confirmation . Adjusted prevalence proportion ratios ( adj . PPRs ) of HIV prevalence were determined using log-binomial regression models . Results Overall baseline HIV prevalence was 26.7 % and was higher in women than men ( 32.6 % vs. 20.8 % , p<0.0001 ) . Prevalence was lower among fishermen ( 22.4 % ) than housewives ( 32.1 % ) , farmers ( 33.1 % ) and bar/lodge/restaurant workers ( 37 % ) . The adj . PPR of HIV was higher among women than men ( adj . PPR = 1.50 , 95 % ; 1.20 , 1.87 ) and participants aged 30–39 years ( adj . PPR=1.40 , 95 % ; 1.10 , 1.79 ) and 40–49 years ( adj . PPR=1.41 , 95 % ; 1.04 , 1.92 ) compared to those aged 18–24 years . Other factors associated with HIV prevalence included low education , previous marriage , polygamous marriage , alcohol and marijuana use before sex . WTP in hypothetical vaccine trials was 89.3 % and was higher in men than women ( 91.2 % vs. 87.3 % , p=0.004 ) and among isl and communities compared to lakeshore ones ( 90.4 % vs. 85.8 % , p=0.004 ) . Conclusions The HIV prevalence in the general fisher-folk population in Ug and a is similar to that observed in the “ high-risk ” fisher folk . FFC have very high levels of willingness to participate in future HIV vaccine trials BACKGROUND In setting s where multiple HIV prevention trials are conducted in close proximity , trial participants may attempt to enroll in more than one trial simultaneously . Co-enrollment impacts on participant 's safety and validity of trial results . We describe our experience , remedial action taken , inter-organizational collaboration and lessons learnt following the identification of co-enrolled participants . EXPERIENCES Between February and April 2008 , we identified 185 of the 398 enrolled participants as ineligible . In violation of the study protocol exclusion criteria , there was simultaneous enrollment in another  HIV prevention trial  ( ineligible co-enrolled , n=135 ) , and enrollment of women who had participated in a microbicide trial within the past 12 months ( ineligible not co-enrolled , n=50 ) . Following a complete audit of all enrolled participants , ineligible participants were discontinued via study exit visits from trial follow-up . Custom- design ed education program on co-enrollment impacting on participants ' safety and validity of the trial results was implemented . Shared electronic data base between research units was established to enable verification of each volunteer 's trial participation and to prevent future co-enrollments . LESSONS LEARNT Interviews with ineligible enrolled women revealed that high- quality care , financial incentives , altruistic motives , preference for sex with gel , wanting to increase their likelihood of receiving active gel , perceived low risk of discovery and peer pressure are the reasons for their enrollment in the CAPRISA 004 trial . CONCLUSION Instituting education programs based on the reasons reported by women for seeking enrollment in more than one trial and using a shared central data base system to identify co-enrollments have effectively prevented further co-enrollments Background and Purpose — Most stroke rehabilitation studies have been performed in high-income countries . The aim of this study was to identify the main barriers for patient inclusion in a research protocol performed in Brazil . Methods — We evaluated reasons for exclusion of patients in a pilot , r and omized , double-blinded clinical trial of stroke rehabilitation .  Descriptive statistical analysis was performed . Results — Only 5.6 % of 571 screened patients were included . Recurrent stroke was responsible for exclusion of 45.4 % of potentially eligible patients . Conclusions — Recurrent stroke represented a big barrier to enroll patients in the protocol . External validity of rehabilitation trials will benefit from definition of study criteria according to regional characteristics of patients , including rates of recurrent stroke . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01333579 Background In the past , clinical study participants have suffered from the experiments that they were subjected to . Study subjects may not underst and the study process or may participate in clinical studies because they do not have access to medical care . The objectives of the present study were 1 . to analyze the motives that might cause a volunteer to participate as a study subject ; 2 . to identify the social-demographic profile of this study subjects ; and 3 . to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil . Methods Mixed- methods research was used ( a qualitative-quantitative approach ) . A sample of 80 volunteers underwent a semi-structured interview  , which was based on a survey script that was elaborated from discussion s with key informants . The sample was r and omly selected from a data base of clinical study volunteers that was provided by Brazilian clinical study centers . The interviews were recorded and transcribed . Descriptive statistics were used for content analysis , including contingency tables with hypothesis testing . Results The motivations for clinical study participation were linked to types of benefit . The most frequently encountered motivations were financial gain and therapeutic alternative . Altruism was not a common motivator , and when altruism was present , it was observed as a secondary motivator . All participants reported that they understood the Informed Consent Statement ( ICS ) . However , only two parts of the form were remembered by all of the volunteers : the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study . Conclusions The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies . Whether these study participants had an integral underst and ing of the ICS is not clear Background Mexico has the highest adult overweight and obesity prevalence in the Americas ; 23.8 % of children < 5 years old are at risk for overweight and 9.7 % are already overweight or obese . Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social ( IMSS ) clinics . Methods We r and omized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care . We recruited 306 parent-child pairs : 168 intervention , 138 usual care . Children were 2 - 5 years old with WHO body mass index ( BMI ) z-score 0 - 3 . We measured children ’s height and weight and parents reported children ’s diet and physical activity at baseline and 3 and 6-month follow-up . We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values . Results 93 ( 55 % ) intervention and 96 ( 70 % ) usual care families completed 3 and 6-month follow-up . At 3 months , intervention v. usual care children  increased vegetables by 6.3 servings/week ( 95 % CI , 1.8 , 10.8 ) . In stratified analyses , intervention participants with high program adherence ( 5 - 6 sessions ) decreased snacks and screen time and increased vegetables v. usual care .  No further effects on behavioral outcomes or BMI were observed . Transportation time and expenses were barriers to adherence . 90 % of parents who completed the post-intervention survey were satisfied with the program . Conclusions Although satisfaction was high among participants , barriers to participation and retention included transportation cost and time . In intention to treat analyses , we found intervention effects on vegetable intake , but not other behaviors or BMI .Trial registration Clinical Trials.gov NCT01539070.Comisión Nacional de Investigación Científica del IMSS : 2009 - 785 - 120 The study objective was to assess willingness of men who have sex with men ( MSM ) enrollled in a vaccine preparedness study ( ' Projeto Rio ' ) to participate in phase III anti-HIV/AIDS vaccine trials . Overall , 57 % of Projeto Rio participants stated they would participate in a putative vaccine trial . MSM who reported commercial sex work were significantly ( p<0.05 ) more likely to engage in risky behaviours than others . In bivariate analysis , commercial sex workers ( CSWs ) were significantly ( p<0.05 ) more likely than non-commercial sex workers ( NCSWs ) to be willing to participate in vaccine trials ( 62.6 % versus 51.4 % ) . Among those willing , CSWs reported significantly more often ( p<0.05 ) ( 50.5 % ) than NCSWs ( 38.0 % ) that they would enroll to protect themselves from HIV . In multivariate analyses , variables associated with willingness to participate ( WTP ) were lower educational level , positive serology for syphilis , and ' engagement , under the influence of alcohol , in risky sexual practice s that would normally be avoided ' , but not commercial sex work . The potential enrollment in vaccine trials of MSM CWSs , as well as participants of low socio-economic status and high risk , seems thus to be possible Background During the last decade , the number of clinical trials conducted in sub-Saharan Africa has increased significantly which has helped to address priority health problems in the region . Navrongo health research centre since it was established in 1989 , has conducted several trial studies including rectal artesunate trial in the Kassena-Nankana districts . However , there is little evidence -based for assessing the impact of new drug trials . This study explored factors that motivate parents to allow their children to participate in new drug trials in northern Ghana . Method The study used both quantitative and qualitative methods . The participants were r and omly selected from among parents whose children were enrolled in a new drug trial conducted in the Kassena-Nankana districts between 2000 and 2003 . QSR Nvivo 9 software was used to code the qualitative data into themes before analysis while STATA software Version 11.2 © was used to analyze the quantitative data . Results The results showed that majority ( 95.9 % ) of the parents were willing to allow their children to be enrolled in future new drug trials . The main factors motivating their willingness to allow their children to be enrolled in these trials were quality of health care services offered to trial participants ( 92.9 % ) , detail medical examination ( 90.8 % ) , promptness of care provided ( 94.4 % ) and quality of drugs ( 91.9 % ) . Other factors mentioned included disease prevention ( 99.5 % ) 
    Output:
    
Altruism , personal health benefits , access to health care , monetary benefit , knowledge , social support and trust were the most important reasons for participation .
Primary reasons for non‐participation were safety concerns , inconvenience , stigmatisation , lack of social support , confidentiality concerns , physical pain , efficacy concerns and distrust .
Stigmatisation was a major concern in relation to HIV research .
Reasons were similar across different regions , gender , non‐patient or patient participants and real or hypothetical study design s. Conclusions Addressing factors that affect (non‐)participation in the planning process and during the conduct of research may enhance voluntary consent to participation and reduce barriers for potential participants