AIDS, SupplementPub Date : 1997-02-01DOI: 10.1097/00002030-199702001-00008
T. Hartwell, W. Schlenger, L. LaVange, D. McFadden, N. Hansen, R. Perritt, W. Poole
{"title":"Collecting sexually transmitted disease clinic chart data in multisite studies","authors":"T. Hartwell, W. Schlenger, L. LaVange, D. McFadden, N. Hansen, R. Perritt, W. Poole","doi":"10.1097/00002030-199702001-00008","DOIUrl":"https://doi.org/10.1097/00002030-199702001-00008","url":null,"abstract":"ion of biological data in support of the NIMH Multisite HIV Prevention Trial STD reinfection (i.e., incident STD in the follow-up period) is one of the clinical endpoints for the STD populations. Although STD data were collected for male and female clients at the STD clinics, there was concern that reinfection would not be detectable among female participants due to the asymptomatic nature of some diseases in women (e.g., C. trachomatis). For each follow-up period, clinical records were systematically checked to determine whether each participant had been treated at the clinic during the period, and if so, what clinical impressions, treatments, and laboratory test results were recorded. STD clients provided written consent for study personnel to obtain data from clinic records. Biologic endpoint abstraction form Even though laboratory tests were performed on many clients, because of missing data, the syndromic approach to STD identification was used in this trial for determining incident infection for members of the male and female STD populations. A biologic endpoint abstraction form was designed to obtain information for making syndromic evaluations of STD (Fig. 1). The abstraction form was developed by tr ial consultants and investigators and STD clinicians from three participating sites who reviewed a sample abstracting form, made recommendations for its expansion, and then reviewed the revised form. Consultants and investigators reviewed clinic charts from STD clinics at all sites and designed two versions of baseline and follow-up forms for use at all clinics, based on the data that were available in the charts. Both versions of the abstraction form collected demographic information, the reason for the current visit, information about prior STD, laboratory test results (both immediate tests and tests ordered), and clinical impressions. On the longer form, the abstractor also collected information about risk factors and HIV testing, and this form was used when such data were available. Follow-up forms were designed to be completed for each visit during the period between the baseline visit and 13 months after the end of the intervention. Follow-up forms were similar to the baseline forms, but information on referral for further services or treatment was omitted. Method of STD data collection The unit of analysis for abstraction was the patient visit. Thus, patients may have had none, one, or multiple visits over a subsequent year. In the tr ial’s pilot study, the number of return visits ranged from 0 to 14. Where possible, a trained nurse abstractor conducted the record abstraction; a study clinician at each site assisted in the determination of local charting practices, as well as in maintaining quality control of the data collection procedures. A second staff member reabstracted data for 20% of the cases randomly selected by the coordinating center so that inter-abstractor reliability could be assessed. Although it was recommended that a t","PeriodicalId":133742,"journal":{"name":"AIDS, Supplement","volume":"2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1997-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134195663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AIDS, SupplementPub Date : 1997-02-01DOI: 10.1097/00002030-199702001-00003
{"title":"Demographic and behavioral predictors of sexual risk in the NIMH Multisite HIV Prevention Trial","authors":"","doi":"10.1097/00002030-199702001-00003","DOIUrl":"https://doi.org/10.1097/00002030-199702001-00003","url":null,"abstract":"The intent of the NIMH Multisite HIV Prevention Trial was to test an intervention to reduce high-risk sexual behaviors. To this end, participants were recruited from sexually transmitted disease (STD) clinics and health service organizations (HSO) for low-income women in endemic areas. Each person entered in the trial reported at least one risky act within the previous 90 days. However, there was considerable variation in risk levels with some individuals reporting few and others reporting many r isky acts. Previous research suggests that certain demographic and behavioral factors influence one’s level of HIV risk behavior. However, much of this past work has been conducted with national probability samples, community samples, or college students [1–3]. The extent to which the same set of factors helps predict the extent of HIV risk among individuals who currently report risk behaviors has not been thoroughly examined. Understanding who is at greatest r isk in a given population can provide direction for the development and targeting of HIV interventions and the effective use of limited resources. For example, such information may be useful to health educators and other service providers who may need to select only the highest risk clients for intensive intervention efforts because of limited budgets.","PeriodicalId":133742,"journal":{"name":"AIDS, Supplement","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1997-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130722149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AIDS, SupplementPub Date : 1997-02-01DOI: 10.1097/00002030-199702001-00002
{"title":"Screening, recruiting and predicting retention of participants in the NIMH Multisite HIV Prevention Trial","authors":"","doi":"10.1097/00002030-199702001-00002","DOIUrl":"https://doi.org/10.1097/00002030-199702001-00002","url":null,"abstract":"If HIV prevention efforts are to be successful on a national level, scientists and collaborators in agency and community settings must demonstrate that they can recruit and influence behavior change with those at highest risk for contracting HIV. The NIMH Multisite HIV Prevention Trial was designed as a phase III clinical trial to determine the efficacy of an HIV intervention program, Project LIGHT, across geographic regions, cities, and clinics with differing populations and service under different delivery conditions. This article describes recruitment, screening, enrollment, and retention among a sample composed of individuals eligible for participation in the HIV prevention trial. Predictors of attrition are identified among the randomized cohort.","PeriodicalId":133742,"journal":{"name":"AIDS, Supplement","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1997-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115283754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AIDS, SupplementPub Date : 1997-02-01DOI: 10.1097/00002030-199702001-00005
{"title":"Endpoints and other measures in the NIMH Multisite HIV Prevention Trial: rationale and psychometric properties","authors":"","doi":"10.1097/00002030-199702001-00005","DOIUrl":"https://doi.org/10.1097/00002030-199702001-00005","url":null,"abstract":"The ultimate purpose of HIV prevention efforts is to interrupt future transmission of HIV infection. HIV is transmitted when infected blood, semen, or possibly other bodily fluids from one person is introduced into the bloodstream (directly or via the mucosa) of another person. This can happen in a relatively limited number of ways, most commonly through insertive sexual activity (e.g., and vaginal or oral intercourse), use of contaminated syringes or needles, or perinatally from infected mothers to their children during pregnancy, delivery or breastfeeding.","PeriodicalId":133742,"journal":{"name":"AIDS, Supplement","volume":"47 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1997-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132367898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
AIDS, SupplementPub Date : 1997-02-01DOI: 10.1097/00002030-199702001-00007
T. Hartwell, W. Schlenger, L. LaVange, D. McFadden, N. Hansen, R. Perritt, W. Poole
{"title":"Definition of adverse reactions in clinical trials of a behavioral intervention","authors":"T. Hartwell, W. Schlenger, L. LaVange, D. McFadden, N. Hansen, R. Perritt, W. Poole","doi":"10.1097/00002030-199702001-00007","DOIUrl":"https://doi.org/10.1097/00002030-199702001-00007","url":null,"abstract":"An important tenet in the ethical conduct of research is to evaluate the risk–benefit ratio for each participant as part of obtaining informed consent [1]. Identifying potential adverse reactions to treatment has long been a major touchstone for risk assessment in drug efficacy trials and treatment. In the conduct of clinical drug trials, safety data, including adverse reactions, are carefully documented and have become an important part of the indication to use the drugs to treat people in the public health system. Trials of behavioral interventions, including interventions that assist individuals in reducing their r isk of contracting HIV, have the potential to confer not only benefits but also risks. Procedures are needed to systematically detect, monitor, and respond to adverse events in clinical trials of behavioral interventions.","PeriodicalId":133742,"journal":{"name":"AIDS, Supplement","volume":"51 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1997-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130653098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}