Methodological lessons from clinical trials and the future of microbicide research

doi:10.1007/s11904-012-0141-9

Review

. 2013 Mar;10(1):89-102.

doi: 10.1007/s11904-012-0141-9.

Methodological lessons from clinical trials and the future of microbicide research

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

Affiliations

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

Review

Methodological lessons from clinical trials and the future of microbicide research

Ariane van der Straten et al. Curr HIV/AIDS Rep. 2013 Mar.

. 2013 Mar;10(1):89-102.

doi: 10.1007/s11904-012-0141-9.

Authors

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

Affiliation

¹ Women's Global Health Imperative, RTI International, 114 Sansome Street, Suite 500, San Francisco, CA 94104, USA. ariane@rti.org

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

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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Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE.
Mensch BS, Richardson BA, Husnik M, Brown ER, Kiweewa FM, Mayo AJ, Baeten JM, Palanee-Phillips T, van der Straten A; MTN-020/ASPIRE study team. Mensch BS, et al. AIDS Behav. 2019 Feb;23(2):504-512. doi: 10.1007/s10461-018-2261-8. AIDS Behav. 2019. PMID: 30218318 Free PMC article. Clinical Trial.
Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study.
van der Straten A, Brown ER, Marrazzo JM, Chirenje MZ, Liu K, Gomez K, Marzinke MA, Piper JM, Hendrix CW; MTN-003 VOICE Protocol Team for Microbicide Trials Network. van der Straten A, et al. J Int AIDS Soc. 2016 Feb 4;19(1):20642. doi: 10.7448/IAS.19.1.20642. eCollection 2016. J Int AIDS Soc. 2016. PMID: 26850270 Free PMC article. Clinical Trial.
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Nair G, Celum C, Szydlo D, Brown ER, Akello CA, Nakalega R, Macdonald P, Milan G, Palanee-Phillips T, Reddy K, Tahuringana E, Muhlanga F, Nakabiito C, Bekker LG, Siziba B, Hillier SL, Baeten JM, Garcia M, Johnson S, McClure T, Levy L, Livant E, Jacobson C, Soto-Torres L, van der Straten A, Hosek S, Rooney JF, Steytler J, Bunge K, Parikh U, Hendrix C, Anderson P, Ngure K; REACH Protocol Team. Nair G, et al. Lancet HIV. 2023 Dec;10(12):e779-e789. doi: 10.1016/S2352-3018(23)00227-8. Epub 2023 Oct 25. Lancet HIV. 2023. PMID: 37898146 Free PMC article. Clinical Trial.
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[1] J Antimicrob Chemother. 2005 May;55(5):616-27 - PubMed

[2] J Antimicrob Chemother. 2005 May;55(5):616-27 - PubMed

[3] AIDS Behav. 2008 Jan;12(1):86-94 - PubMed

[4] AIDS Behav. 2008 Jan;12(1):86-94 - PubMed

[5] Cochrane Database Syst Rev. 2012 Mar 14;(3):CD009756 - PubMed

[6] Cochrane Database Syst Rev. 2012 Mar 14;(3):CD009756 - PubMed

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[8] J Forensic Sci. 2012 Mar;57(2):489-99 - PubMed

[9] Sex Transm Dis. 2010 Jun;37(6):361-4 - PubMed

[10] Sex Transm Dis. 2010 Jun;37(6):361-4 - PubMed

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Methodological lessons from clinical trials and the future of microbicide research

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Methodological lessons from clinical trials and the future of microbicide research

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