Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.

Abstract:

OBJECTIVES:Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants. METHODS:Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants. RESULTS:A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment. CONCLUSIONS:These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world.

journal_name

HIV Med

journal_title

HIV medicine

authors

Denning E,Sharma S,Smolskis M,Touloumi G,Walker S,Babiker A,Clewett M,Emanuel E,Florence E,Papadopoulos A,Sánchez A,Tavel J,Grady C,International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Grou

doi

10.1111/hiv.12230

subject

Has Abstract

pub_date

2015-04-01 00:00:00

pages

24-9

eissn

1464-2662

issn

1468-1293

journal_volume

16 Suppl 1

pub_type

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/hiv.12158

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    更新日期:2014-10-01 00:00:00

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    pub_type: 杂志文章

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    authors: Manosuthi W,Sungkanuparph S,Vibhagool A,Rattanasiri S,Thakkinstian A

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    journal_title:HIV medicine

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

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    更新日期:2004-07-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1111/hiv.12831

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    pub_type: 杂志文章

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    pub_type: 杂志文章

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    更新日期:2011-01-01 00:00:00

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    pub_type: 杂志文章,随机对照试验

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    pub_type: 杂志文章

    doi:10.1111/hiv.12807

    authors: Croxford S,Tavoschi L,Sullivan AK,Combs L,Raben D,Delpech V,Jakobsen SF,Amato-Gauci AJ,Desai S

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    journal_title:HIV medicine

    pub_type: 杂志文章

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    authors: Barry SM,Lipman MC,Deery AR,Johnson MA,Janossy G

    更新日期:2002-07-01 00:00:00

  • Community-onset methicillin-resistant Staphylococcus aureus in an urban HIV clinic.

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2006.00394.x

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  • The management of dyslipidaemias in antiretroviral-treated HIV infection: a systematic review.

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    journal_title:HIV medicine

    pub_type: 杂志文章,评审

    doi:10.1111/j.1468-1293.2007.00480.x

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    更新日期:2007-09-01 00:00:00

  • Total and unbound darunavir pharmacokinetics in pregnant women infected with HIV-1: results of a study of darunavir/ritonavir 600/100 mg administered twice daily.

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    journal_title:HIV medicine

    pub_type: 临床试验,杂志文章,多中心研究

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    journal_title:HIV medicine

    pub_type: 杂志文章,多中心研究

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    authors: McDonald C,Curtis H,de Ruiter A,Johnson MA,Welch J,British HIV Association (BHIVA) and the BHIVA audit subcommittee.

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  • Regulation of adiponectin in adipocytes upon exposure to HIV-1.

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2006.00372.x

    authors: Sankalé JL,Tong Q,Hadigan CM,Tan G,Grinspoon SK,Kanki PJ,Hotamisligil GS

    更新日期:2006-05-01 00:00:00

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    pub_type: 杂志文章,多中心研究,随机对照试验

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    journal_title:HIV medicine

    pub_type: 杂志文章,随机对照试验

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    更新日期:2014-01-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 临床试验,杂志文章,随机对照试验

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    更新日期:2003-04-01 00:00:00

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    pub_type: 杂志文章,评审

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    更新日期:2000-07-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2007.00428.x

    authors: Casula M,van der Valk M,Wit FW,Nievaard MA,Reiss P

    更新日期:2007-01-01 00:00:00

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    pub_type: 杂志文章,评审

    doi:10.1111/j.1468-1293.2012.00992.x

    authors: Thornton AC,Delpech V,Kall MM,Nardone A

    更新日期:2012-08-01 00:00:00

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/hiv.12164

    authors: Else LJ,Jackson V,Brennan M,Back DJ,Khoo SH,Coulter-Smith S,Lambert JS

    更新日期:2014-11-01 00:00:00

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    abstract:OBJECTIVES:The aim of the study was to compare the effects on lipids, body composition and renal function of once-daily ritonavir-boosted saquinavir (SQV/r) or atazanavir (ATV/r) in combination with tenofovir/emtricitabine (TDF/FTC) over 48 weeks. METHODS:An investigator-initiated, randomized, open-label, multinationa...

    journal_title:HIV medicine

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/j.1468-1293.2011.00941.x

    authors: Vrouenraets SM,Wit FW,Fernandez Garcia E,Moyle GJ,Jackson AG,Allavena C,Raffi F,Jayaweera DT,Mauss S,Katlama C,Fisher M,Slama L,Hardy WD,Dejesus E,van Eeden A,Reiss P,BASIC Study Group.

    更新日期:2011-11-01 00:00:00

  • Treatment initiation factors and cognitive outcome in youth with perinatally acquired HIV infection.

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    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/hiv.12220

    authors: Lazarus JR,Rutstein RM,Lowenthal ED

    更新日期:2015-07-01 00:00:00

  • European AIDS Clinical Society (EACS) guidelines on the prevention and management of metabolic diseases in HIV.

    abstract:BACKGROUND:Metabolic diseases are frequently observed in HIV-infected persons and, as the risk of contracting these diseases is age-related, their prevalence will increase in the future as a consequence of the benefits of antiretroviral therapy (ART). SUMMARY OF GUIDELINES:All HIV-infected persons should be screened a...

    journal_title:HIV medicine

    pub_type: 杂志文章,实务指引

    doi:10.1111/j.1468-1293.2007.00534.x

    authors: Lundgren JD,Battegay M,Behrens G,De Wit S,Guaraldi G,Katlama C,Martinez E,Nair D,Powderly WG,Reiss P,Sutinen J,Vigano A,EACS Executive Committee.

    更新日期:2008-02-01 00:00:00

  • Correction of facial lipoatrophy using autologous fat transplants in HIV-infected adolescents.

    abstract:OBJECTIVES:Antiretroviral therapy has dramatically improved the survival of HIV-infected children. Nevertheless, side effects comparable to those found in adults have been encountered, such as facial lipoatrophy, which can have a negative impact on the self-esteem of otherwise healthy adolescents. Cosmetic surgical pro...

    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2008.00682.x

    authors: Dollfus C,Blanche S,Trocme N,Funck-Brentano I,Bonnet F,Levan P

    更新日期:2009-05-01 00:00:00

  • How reliable is an undetectable viral load?

    abstract:OBJECTIVES:An article by the Swiss AIDS Commission states that patients with stably suppressed viraemia [i.e. several successive HIV-1 RNA plasma concentrations (viral loads, VL) below the limits of detection during 6 months or more of highly active antiretroviral therapy (HAART)] are unlikely to be infectious. Questio...

    journal_title:HIV medicine

    pub_type: 杂志文章

    doi:10.1111/j.1468-1293.2009.00714.x

    authors: Combescure C,Vallier N,Ledergerber B,Cavassini M,Furrer H,Rauch A,Battegay M,Bernasconi E,Vernazza P,Hirschel B,Swiss HIV Cohort Study.

    更新日期:2009-09-01 00:00:00