Title
Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial
Date Issued
01 February 2018
Access level
open access
Resource Type
journal article
Author(s)
Giguere R.
Rael C.T.
Sheinfil A.
Balán I.C.
Brown W.
Ho T.
Dolezal C.
Leu C.S.
Liu A.
Mayer K.H.
McGowan I.
Carballo-Diéguez A.
Cranston R.D.
Publisher(s)
Springer Nature
Abstract
Adherence to product use in biomedical HIV prevention trials is essential to success. In MTN-017, a Phase 2 rectal microbicide gel trial, participants discussed applicator-inserted gel use in the context of receptive anal intercourse (RAI) with adherence counselors. We analyzed counseling session data to identify barriers to and facilitators of gel use for 26 participants in the United States who used gel with RAI as their first of three study regimens. The most common barriers were finding the gel application process cumbersome, physical discomfort after applying gel, difficulty with BAT-24 dosage regimen, and negative effects of gel on sex. The most common facilitators were incorporating gel use into routines, using gel in anticipation of sex, carrying gel when going out, reminders received via short message service, and ease of gel use. These findings can inform product development and future adherence counseling interventions for rectal gel trials to improve adherence outcomes.
Start page
388
End page
401
Volume
22
Issue
2
Language
English
OCDE Knowledge area
Farmacología, Farmacia
Ciencias socio biomédicas (planificación familiar, salud sexual, efectos políticos y sociales de la investigación biomédica)
Subjects
Scopus EID
2-s2.0-85027866909
PubMed ID
Source
AIDS and Behavior
ISSN of the container
10907165
Sponsor(s)
Acknowledgements We are grateful to the study participants for their participation, dedication, and openness in discussing their adherence to gel use. We thank the study team members at the research sites, the protocol management team and the MTN leadership operations center for their contributions. We are grateful to Gilead Sciences who provided the FTC/TDF and CONRAD for providing RG-TFV.
Funding The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases [UM1AI068633, UM1AI068615, UM1AI106707], with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The HIV Center for Clinical and Behavioral Studies is also supported by NIH Center Grant P30 MH43520 (PI: Remien). William Brown III was supported by the NLM (R01-LM012355-01A1 PI: Schillinger; and T15-LM007079, PI: Hripcsak) and the NIMH/NIDA (R03-MH103957, PI: Bakken). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Sources of information:
Directorio de Producción Científica
Scopus