Literature DB >> 23184582

Methodological lessons from clinical trials and the future of microbicide research.

Ariane van der Straten1, Elizabeth T Montgomery, Miriam Hartmann, Alexandra Minnis.   

Abstract

Interpretation of microbicide trial results has been compromised by challenges to accurate measurement of product adherence and sexual risk behaviors. This article provides an evaluation of the methods used to measure adherence and other sensitive behaviors relevant to assessment of product safety and effectiveness in recently completed trials of vaginal and rectal microbicides. We review the strengths and limitations of existing and novel behavioral measurement strategies and provide recommendations for future trial design with the goal of facilitating the development and identification of safe and effective microbicides for HIV prevention.

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Year:  2013        PMID： 23184582     DOI： 10.1007/s11904-012-0141-9

Source DB:  PubMed          Journal:  Curr HIV/AIDS Rep        ISSN： 1548-3568            Impact factor:   5.071


  70 in total

Review 1.  A proposal for quality standards for measuring medication adherence in research.

Authors:  Ann Bartley Williams; K Rivet Amico; Carol Bova; Julie A Womack
Journal:  AIDS Behav       Date:  2013-01

2.  Heterosexual anal intercourse has the potential to cause a significant loss of power in vaginal microbicide effectiveness studies.

Authors:  Ian McGowan; Douglas J Taylor
Journal:  Sex Transm Dis       Date:  2010-06       Impact factor: 2.830

3.  Optimal recall period and response task for self-reported HIV medication adherence.

Authors:  Minyi Lu; Steven A Safren; Paul R Skolnik; William H Rogers; William Coady; Helene Hardy; Ira B Wilson
Journal:  AIDS Behav       Date:  2007-06-19

4.  Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance.

Authors:  Terri Walsh; Lee Warner; Maurizio Macaluso; Ron Frezieres; Margaret Snead; Brian Wraxall
Journal:  Contraception       Date:  2012-03-02       Impact factor: 3.375

5.  Drug concentrations after topical and oral antiretroviral pre-exposure prophylaxis: implications for HIV prevention in women.

Authors:  Salim S Abdool Karim; Angela D M Kashuba; Lise Werner; Quarraisha Abdool Karim
Journal:  Lancet       Date:  2011-07-16       Impact factor: 79.321

6.  Predicting product adherence in a topical microbicide safety trial in Pune, India.

Authors:  Elizabeth E Tolley; Sharon Tsui; Sanjay Mehendale; Mark A Weaver; Rewa Kohli
Journal:  AIDS Behav       Date:  2012-10

7.  PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial.

Authors:  Sheena McCormack; Gita Ramjee; Anatoli Kamali; Helen Rees; Angela M Crook; Mitzy Gafos; Ute Jentsch; Robert Pool; Maureen Chisembele; Saidi Kapiga; Richard Mutemwa; Andrew Vallely; Thesla Palanee; Yuki Sookrajh; Charles J Lacey; Janet Darbyshire; Heiner Grosskurth; Albert Profy; Andrew Nunn; Richard Hayes; Jonathan Weber
Journal:  Lancet       Date:  2010-09-17       Impact factor: 79.321

8.  Biomarker validation of reports of recent sexual activity: results of a randomized controlled study in Zimbabwe.

Authors:  Alexandra M Minnis; Markus J Steiner; Maria F Gallo; Lee Warner; Marcia M Hobbs; Ariane van der Straten; Tsungai Chipato; Maurizio Macaluso; Nancy S Padian
Journal:  Am J Epidemiol       Date:  2009-09-09       Impact factor: 4.897

9.  A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel.

Authors:  Marla J Keller; Rebecca P Madan; N Merna Torres; Melissa J Fazzari; Sylvia Cho; Sabah Kalyoussef; Gail Shust; Pedro M M Mesquita; Nicolette Louissaint; Jianmeng Chen; Hillel W Cohen; Erin C Diament; Anna C Lee; Lydia Soto-Torres; Craig W Hendrix; Betsy C Herold
Journal:  PLoS One       Date:  2011-01-25       Impact factor: 3.240

10.  Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention.

Authors:  Andrew Nunn; Sheena McCormack; Angela M Crook; Robert Pool; Clare Rutterford; Richard Hayes
Journal:  Trials       Date:  2009-10-27       Impact factor: 2.279
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  17 in total

Review 1.  Long acting systemic HIV pre-exposure prophylaxis: an examination of the field.

Authors:  William R Lykins; Ellen Luecke; Daniel Johengen; Ariane van der Straten; Tejal A Desai
Journal:  Drug Deliv Transl Res       Date:  2017-12       Impact factor: 4.617

2.  Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

Authors:  Barbara S Mensch; Elizabeth R Brown; Karen Liu; Jeanne Marrazzo; Zvavahera Mike Chirenje; Kailazarid Gomez; Jeanna Piper; Karen Patterson; Ariane van der Straten
Journal:  AIDS Behav       Date:  2016-11

3.  Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial.

Authors:  Leila Essop Mansoor; Quarraisha Abdool Karim; Lise Werner; Bernadette Madlala; Nelisiwe Ngcobo; Deborah H Cornman; K Rivet Amico; Jeffrey Fisher; William A Fisher; Kathleen M Macqueen; Salim S Abdool Karim
Journal:  AIDS Behav       Date:  2014-05

4.  Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty.

Authors:  Elizabeth T Montgomery; B Mensch; P Musara; M Hartmann; K Woeber; J Etima; A van der Straten
Journal:  AIDS Behav       Date:  2017-02

5.  Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions.

Authors:  Alexandra M Minnis; Ariane van der Straten; Parichat Salee; Craig W Hendrix
Journal:  AIDS Behav       Date:  2016-07

6.  Evaluation of a Multidrug Assay for Monitoring Adherence to a Regimen for HIV Preexposure Prophylaxis in a Clinical Study, HIV Prevention Trials Network 073.

Authors:  Yinfeng Zhang; William Clarke; Mark A Marzinke; Estelle Piwowar-Manning; Geetha Beauchamp; Autumn Breaud; Craig W Hendrix; Gavin A Cloherty; Lynda Emel; Scott Rose; Lisa Hightow-Weidman; Marc Siegel; Steven Shoptaw; Sheldon D Fields; Darrell Wheeler; Susan H Eshleman
Journal:  Antimicrob Agents Chemother       Date:  2017-06-27       Impact factor: 5.191

7.  Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066).

Authors:  Craig W Hendrix; Adriana Andrade; Namandjé N Bumpus; Angela D Kashuba; Mark A Marzinke; Ayana Moore; Peter L Anderson; Lane R Bushman; Edward J Fuchs; Ilene Wiggins; Christine Radebaugh; Heather A Prince; Rahul P Bakshi; Ruili Wang; Paul Richardson; Eugenie Shieh; Laura McKinstry; Xin Li; Deborah Donnell; Vanessa Elharrar; Kenneth H Mayer; Kristine B Patterson
Journal:  AIDS Res Hum Retroviruses       Date:  2015-10-15       Impact factor: 2.205

8.  Disclosure of pharmacokinetic drug results to understand nonadherence.

Authors:  Ariane van der Straten; Elizabeth T Montgomery; Petina Musara; Juliane Etima; Sarita Naidoo; Nicole Laborde; Miriam Hartmann; Lisa Levy; Thola Bennie; Helen Cheng; Jeanna Piper; Cynthia I Grossman; Jeanne Marrazzo; Barbara Mensch
Journal:  AIDS       Date:  2015-10-23       Impact factor: 4.177

9.  Evaluation of 3 approaches for assessing adherence to vaginal gel application in clinical trials.

Authors:  Ariane van der Straten; Helen Cheng; Barbara Mensch; Barbara Friedland; Lauren Katzen; Sarah Littlefield; Niall Buckley; Lilia Espinoza; Marla J Keller; Betsy C Herold; Mark H Einstein
Journal:  Sex Transm Dis       Date:  2013-12       Impact factor: 2.830

10.  Use of the dye stain assay and ultraviolet light test for assessing vaginal insertion of placebo-filled applicators before and after sex.

Authors:  Marla J Keller; Niall Buckley; Lauren L Katzen; Jennifer Walsh; Barbara Friedland; Sarah Littlefield; Juan Lin; Xiaonan Xue; Terri Cornelison; Betsy C Herold; Mark H Einstein
Journal:  Sex Transm Dis       Date:  2013-12       Impact factor: 2.830
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