Adolescent Medicine Trials Network for HIV/AIDS Interventions Data Harmonization: Rationale and Development of Guidelines.
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ABSTRACT: Background
The Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) research program aims to defeat the rising HIV epidemic among adolescents and young adults in the United States.Objective
This study aims to optimize cross-study analyses and comparisons of standardized measures (variables) collected in the ATN.Methods
Guidelines were developed for harmonizing measures to be collected across ATN studies.Results
Eight domains were identified for harmonization-Demographics and Socioeconomic Characteristics, Sexual Behavior and Risk, Substance Use and Abuse, HIV-Positive Cascade, HIV-Negative Cascade, Mental Health, Social Support and Isolation, and Pre-exposure Prophylaxis Cascade.Conclusions
The collection of selected key measures in a uniform manner across studies facilitates the characterization of participant populations, comparisons between studies, and pooled analysis of data from multiple studies.
SUBMITTER: McCumber M
PROVIDER: S-EPMC6320398 | biostudies-literature | 2018 Dec
REPOSITORIES: biostudies-literature
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Project description:BackgroundOne of the most difficult areas in the fight against HIV/AIDS is reaching out to youth aged 13 to 24 years. The proportion of youth living with HIV/AIDS on antiretroviral therapy (ART) and who are virally undetectable is low, highlighting significant challenges for reaching the Joint United Nations Program on HIV targets.ObjectiveThis study aimed to assess the feasibility of obtaining key clinical indicators and monitoring treatment, viral suppression, and retention components of the youth HIV treatment cascade in Adolescent Trials Network for HIV/AIDS Interventions clinics using electronic health record (EHR) downloads and to provide baseline characteristics for the study participants.MethodsEHR data were systematically obtained from multiple clinical sites and used to meaningfully capture clinical characteristics, initiation of antiretrovirals, and retention in care, which are part of the Centers for Disease Control and Prevention's 4 continuum of care measures. In addition, this study used standard cost values attached to Current Procedural Terminology codes to estimate the cost per visit.ResultsOnly 2 of the 4 Centers for Disease Control and Prevention treatment cascade measures were assessed using routine EHR data. EHR data are not adequate for monitoring HIV testing or linkage to care because denominator data are not available. However, the data work well for measuring ART initiation and adequately for retention in care. The sites were broadly able to provide information for the required data. However, in most cases, these data are insufficient for identifying patterns of missed appointments because such misses are not captured in the EHR system. Sites with good access to data management resources can operate more efficiently for cascade monitoring study purposes.ConclusionsData other than EHRs are needed to measure HIV testing and linkage to youth care. EHR data are useful for measuring ART initiation and work moderately well for measuring retention in care. Site data management resources should be part of the selection process when looking for site partners for clinical studies that plan to use EHR data. Study planners should determine the feasibility of additional funding for organizations in need of additional information technology or data management resources.
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Project description:Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration. These specifics, combined with the characteristics of the study population, will have an impact on the design and ethics of RCTs. The recently closed JUVENTAS trial will serve as an example to identify the (interwoven) scientific and ethical challenges in the design and launch of stem cell RCTs. The JUVENTAS trial has investigated the efficacy of autologous bone marrow cells in end-stage vascular patients, in a double-blind sham-controlled design. We first describe the choices, considerations, and experiences of the JUVENTAS team. Subsequently, we identify the main ethical and scientific challenges and discuss what is important to consider in the design of future stem cell RCTs: assessment of risks and benefits, the choice for outcome measures, the choice for the comparator, the appropriate selection of participants, and adequate informed consent. Additionally, the stem cell field is highly in the spotlight due to the (commercial) interests and expectations. This warrants a cautious pace of translation and scrupulous set up of clinical trials, as failures could put the field in a negative light. At the same time, knowledge from clinical trials is necessary for the field to progress. We conclude that in the scientifically and ethically challenging field of stem cell RCTs, researchers and clinicians have to maneuver between the Skylla of hyper accelerated translation without rigorously conducted RCTs and the Charybdis of the missed opportunity of valuable knowledge.
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Project description:Adolescent and Young Adult Oncology (AYAO, including patients 15-39 years of age) is an emerging discipline in the field of cancer treatment and research. Poorer survival outcomes for this population and characteristic age-related challenges in care have called attention to the need for increased AYAO research. This chapter outlines pressing questions and reviews recent progress in AYAO research within the current organizational structure of the federal clinical trials enterprise, emphasizing how the United States National Cancer Institute's National Clinical Trials Network (NCTN) has created novel opportunities for collaborative AYAO research among the pediatric and adult NCTN groups. Potential strategies for expanding AYAO research, both within the NCTN and with other partners in the federal and advocacy domains are identified.
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Project description:BackgroundDespite sub-Saharan Africa [SSA] constituting just 12% of the world's population, the region has the highest burden of HIV with 70% of HIV infection in general and 80% of new infections among young people occuring in the region. Diverse intervention programmes have been implemented among young people but with minimal translation to behavior change. A systematic review of Behavior Change Interventions [BCI] targeting adolescents in SSA was therefore conducted with the objective of delineating this intervention vis-a-vis efficacy gap.MethodsFrom April to July 2015 searches were made from different journals online. Databases searched included MEDLINE, EBSCOhost, PsychINFO, Cochrane, and Google Scholar; Cambridge and Oxford journal websites, UNAIDS and WHO for studies published between 2000 and 2015. After excluding other studies by review of titles and then abstracts, the studies were reduced to 17. Three of these were randomized trials and five quasi-experimental. Overall interventions included those prescribing life skills, peer education [n = 6] and community collaborative programmes. The main study protocol was approved by the University of Malawi College of Medicine Ethics Committee on 30th June 2016 [ref #: P.01/16/1847. The review was registered with PROSPERO [NIH] in 2015.ResultsThe review yielded some 200 titles and abstracts, 20 full text articles were critically analysed and 17 articles reviewed reflecting a dearth in published studies in the area of psychosocial BCI interventions targeting adolescents in SSA. Results show that a number of reviewed interventions [n = 8] registered positive outcomes in both knowledge and sexual practices.ConclusionsThe review demonstrates a paucity of psychosocial BCI studies targeting adolescents in SSA. There are however mixed findings about the effectiveness of psychosocial BCI targeting adolescents in SSA. Other studies portray intervention effectiveness and others limited efficacy. Peer education as an intervention stands out as being more effective than other psychosocial regimens, like life skills, in facilitating HIV risk reduction. There is therefore need for further research on interventions employing peer education to substantiate their potential efficacy in HIV risk reduction among adolescents.Prospero registration numberCRD42015019244, available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015019244 .
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Project description:IntroductionTo effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs). Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008.ObjectivesTo describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008.MethodsWe searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders.ResultsOur search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20), Zambia (12) and Zimbabwe (9). The median sample size was 628 (range 33-9645). Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA) and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials.ConclusionPrevention trials dominate the trial landscape in Africa. Of note, few principal investigators and funders are from Africa. These findings mirror our previous work and continue to indicate a need for strengthening trial research capacity in Africa.
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