Literature DB >> 23032737

Acceptability in microbicide and PrEP trials: current status and a reconceptualization.

Barbara S Mensch1, Ariane van der Straten, Lauren L Katzen.   

Abstract

PURPOSE OF REVIEW: Assessment of acceptability is a central component of most oral PrEP and microbicide trials. In this paper we review current definitions and frameworks employed in acceptability research, discuss findings from recent studies of product acceptability and summarize trends in acceptability research. We conclude by offering a new framework for investigating product acceptability within clinical trials, one which considers product acceptability to be conceptually distinct from adherence. RECENT
FINDINGS: Although numerous studies have investigated product acceptability, a consensus is lacking regarding the definition and operationalization of the concept. In addition fewer than half of the studies reviewed investigated actual candidate products. To the extent that an overall measure of acceptability is considered, the consensus is that most participants find the products acceptable. However, it is the rare study that investigates whether product adherence is associated with acceptability.
SUMMARY: Given that adherence is critical to the success of clinical trials, it is important to identify the extent to which acceptability is a factor in product usage and to ascertain which dimensions of acceptability - product attributes, dosing regimen, delivery mechanism, use attributes, partner's attitudes, effect of product on the sexual encounter, product-related norms - if any, affect adherence.

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Year:  2012        PMID: 23032737      PMCID: PMC4026162          DOI: 10.1097/COH.0b013e3283590632

Source DB:  PubMed          Journal:  Curr Opin HIV AIDS        ISSN: 1746-630X            Impact factor:   4.283


  36 in total

1.  The female condom: beyond acceptability to public health impact.

Authors:  T Hatzell; P J Feldblum
Journal:  Sex Transm Dis       Date:  2001-11       Impact factor: 2.830

2.  High acceptability of a vaginal ring intended as a microbicide delivery method for HIV prevention in African women.

Authors:  A van der Straten; E T Montgomery; H Cheng; L Wegner; G Masenga; C von Mollendorf; L Bekker; S Ganesh; K Young; J Romano; A Nel; C Woodsong
Journal:  AIDS Behav       Date:  2012-10

3.  Willingness of Kenyan HIV-1 serodiscordant couples to use antiretroviral-based HIV-1 prevention strategies.

Authors:  Renee Heffron; Kenneth Ngure; Nelly Mugo; Connie Celum; Ann Kurth; Kathryn Curran; Jared M Baeten
Journal:  J Acquir Immune Defic Syndr       Date:  2012-09-01       Impact factor: 3.731

4.  A framework for examining the sustained acceptability of microbicides.

Authors:  Lawrence J Severy; Elizabeth Tolley; Cynthia Woodsong; Greg Guest
Journal:  AIDS Behav       Date:  2005-03

5.  Assessing microbicide acceptability: a comprehensive and integrated approach.

Authors:  Kathleen M Morrow; Monica S Ruiz
Journal:  AIDS Behav       Date:  2007-06-26

6.  Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004).

Authors:  Ian McGowan; Kailazarid Gomez; Karen Bruder; Irma Febo; Beatrice A Chen; Barbra A Richardson; Marla Husnik; Edward Livant; Clare Price; Cindy Jacobson
Journal:  AIDS       Date:  2011-05-15       Impact factor: 4.177

Review 7.  Methodological problems in AIDS behavioral research: influences on measurement error and participation bias in studies of sexual behavior.

Authors:  J A Catania; D R Gibson; D D Chitwood; T J Coates
Journal:  Psychol Bull       Date:  1990-11       Impact factor: 17.737

8.  Acceptability of vaginal film, soft-gel capsule, and tablet as potential microbicide delivery methods among African women.

Authors:  Annalene M Nel; Lynne B Mitchnick; Peter Risha; Lungwani Tyson Makoye Muungo; Pamela M Norick
Journal:  J Womens Health (Larchmt)       Date:  2011-07-20       Impact factor: 2.681

9.  Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, 'Praneem polyherbal tablet', in Pune, India.

Authors:  N S Joglekar; S N Joshi; S S Deshpande; A N Parkhe; U R Katti; S M Mehendale
Journal:  Trans R Soc Trop Med Hyg       Date:  2010-01-22       Impact factor: 2.184

10.  Willingness to accept HIV pre-exposure prophylaxis among Chinese men who have sex with men.

Authors:  Feng Zhou; Lei Gao; Shuming Li; Dongliang Li; Lifen Zhang; Wensheng Fan; Xueying Yang; Mingrun Yu; Dong Xiao; Li Yan; Zheng Zhang; Wei Shi; Fengji Luo; Yuhua Ruan; Qi Jin
Journal:  PLoS One       Date:  2012-03-30       Impact factor: 3.240

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  40 in total

1.  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

2.  Acceptability and use of a dapivirine vaginal ring in a phase III trial.

Authors:  Elizabeth T Montgomery; Ariane van der Straten; Miria Chitukuta; Krishnaveni Reddy; Kubashni Woeber; Millicent Atujuna; Linda-Gail Bekker; Juliane Etima; Teopista Nakyanzi; Ashley J Mayo; Ariana Katz; Nicole Laborde; Cynthia I Grossman; Lydia Soto-Torres; Thesla Palanee-Phillips; Jared M Baeten
Journal:  AIDS       Date:  2017-05-15       Impact factor: 4.177

Review 3.  Oral pre-exposure prophylaxis (PrEP) for prevention of HIV in serodiscordant heterosexual couples in the United States: opportunities and challenges.

Authors:  James M McMahon; Julie E Myers; Ann E Kurth; Stephanie E Cohen; Sharon B Mannheimer; Janie Simmons; Enrique R Pouget; Nicole Trabold; Jessica E Haberer
Journal:  AIDS Patient Care STDS       Date:  2014-07-21       Impact factor: 5.078

4.  Relationship Type and Use of the Vaginal Ring for HIV-1 Prevention in the MTN 020/ASPIRE Trial.

Authors:  E Pleasants; T Tauya; K Reddy; B G Mirembe; K Woeber; T Palanee-Phillips; C Zimba; M Atujuna; E T Montgomery
Journal:  AIDS Behav       Date:  2020-03

5.  Rectal Douching Practices Associated with Anal Intercourse: Implications for the Development of a Behaviorally Congruent HIV-Prevention Rectal Microbicide Douche.

Authors:  Alex Carballo-Dieguez; Rebecca Giguere; Cody Lentz; Curtis Dolezal; Edward J Fuchs; Craig W Hendrix
Journal:  AIDS Behav       Date:  2019-06

6.  Shape of vaginal suppositories affects willingness-to-try and preference.

Authors:  Bangde Li; Toral Zaveri; Gregory R Ziegler; John E Hayes
Journal:  Antiviral Res       Date:  2012-12-29       Impact factor: 5.970

7.  Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial.

Authors:  Marla J Husnik; Elizabeth R Brown; Mark Marzinke; Edward Livant; Thesla Palanee-Phillips; Craig W Hendrix; Flavia Matovu Kiweewa; Gonasagrie Nair; Lydia E Soto-Torres; Katie Schwartz; Sharon L Hillier; Jared M Baeten
Journal:  J Acquir Immune Defic Syndr       Date:  2017-11-01       Impact factor: 3.731

8.  A Mixed-Methods Study Examining Adherence to and Acceptability of Intravaginal Rings for HIV Prevention: Behavioral Results of MTN-027.

Authors:  José A Bauermeister; Jesse M Golinkoff; Alex Carballo-Diéguez; Rebecca Giguere; Daniela López; Craig J Hoesley; Beatrice A Chen; Peter Anderson; Charlene S Dezzutti; Julie Strizki; Carol Sprinkle; Faye Heard; Wayne Hall; Cindy Jacobson; Jennifer Berthiaume; Ashley Mayo; Barbra A Richardson; Jeanna Piper
Journal:  AIDS Behav       Date:  2020-02

9.  Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex.

Authors:  Nicole D Laborde; Elizabeth Pleasants; Krishnaveni Reddy; Millicent Atujuna; Teopista Nakyanzi; Miria Chitukuta; Sarita Naidoo; Thesla Palanee-Phillips; Jared M Baeten; Elizabeth T Montgomery
Journal:  AIDS Behav       Date:  2018-02

10.  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

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