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AIDS and Behavior
Published in: AIDS and Behavior 2/2018

01-02-2018 | Original Paper

Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial

Authors: Rebecca Giguere, Christine Tagliaferri Rael, Alan Sheinfil, Ivan C. Balán, William Brown III, Titcha Ho, Curtis Dolezal, Cheng-Shiun Leu, Albert Liu, Kenneth H. Mayer, Javier R. Lama, Ian McGowan, Alex Carballo-Diéguez, Ross D. Cranston, on behalf of the MTN-017 Protocol Team

Published in: AIDS and Behavior | Issue 2/2018

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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.
Literature
1.
2.
Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015; 372.
3.
Corneli AL, Deese J, Wang M, et al. FEM-PrEP: adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis. J Acquir Immune Defic Syndr. 2014;66:324–31.CrossRefPubMedPubMedCentral
4.
Montgomery ET, Noguchi LM, Dai JY, et al. Acceptability of and adherence to an antiretroviral-based vaginal microbicide among pregnant women in the United States. AIDS Behav. 2017;1–10.
5.
Minnis AM, Gandham S, Richardson BA, et al. Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. AIDS Behav. 2013;17:737–47.CrossRefPubMedPubMedCentral
6.
Greene E, Batona G, Hallad J, Johnson S, Neema S, Tolley EE. Acceptability and adherence of a candidate microbicide gel among high-risk women in Africa and India. Cult Health Sex. 2010;12:739–54.CrossRefPubMed
7.
8.
Morrow KM, Underhill K, van den Berg JJ, Vargas S, Rosen RK, Katz DF. User-identified gel characteristics: a qualitative exploration of perceived product efficacy of topical vaginal microbicides. Arch Sex Behav. 2014;43:1459–67.CrossRefPubMedPubMedCentral
9.
Galea JT, Kinsler JJ, Salazar X, et al. Acceptability of pre-exposure prophylaxis as an HIV prevention strategy: barriers and facilitators to pre-exposure prophylaxis uptake among at-risk Peruvian populations. Int J STD AIDS. 2011;22:256–62.CrossRefPubMedPubMedCentral
10.
Golub SA, Gamarel KE, Rendina HJ, Surace A, Lelutiu-Weinberger CL. From efficacy to effectiveness: facilitators and barriers to PrEP acceptability and motivations for adherence among MSM and transgender women in New York City. AIDS Patient Care STDS. 2013;27:248–54.CrossRefPubMedPubMedCentral
11.
Corneli A, Perry B, McKenna K, et al. Participants’ explanations for nonadherence in the FEM-PrEP clinical trial. J Acquir Immune Defic Syndr. 2016;71:452–61.CrossRefPubMed
12.
der Elst EM, Mbogua J, Operario D, et al. High acceptability of HIV pre-exposure prophylaxis but challenges in adherence and use: qualitative insights from a phase I trial of intermittent and daily PrEP in at-risk populations in Kenya. AIDS Behav. 2013;17:2162–72.CrossRefPubMedPubMedCentral
13.
Tangmunkongvorakul A, Chariyalertsak S, Amico KR, et al. Facilitators and barriers to medication adherence in an HIV prevention study among men who have sex with men in the iPrEx study in Chiang Mai, Thailand. AIDS Care. 2013;25:961–7.CrossRefPubMed
14.
Succop SM, MacQueen KM, van Loggerenberg F, Majola N, Karim QA, Karim SSA. Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial. AIDS Care. 2014;26:1521–5.CrossRefPubMedPubMedCentral
15.
Van Der Straten A, Stadler J, Montgomery E, et al. Women’s experiences with oral and vaginal pre-exposure prophylaxis: The VOICE-C qualitative study in Johannesburg, South Africa. PLoS One 2014; 9.
16.
Liu AY, Hessol NA, Vittinghoff E, et al. Medication adherence among men who have sex with men at risk for HIV infection in the United States: implications for pre-exposure prophylaxis implementation. AIDS Patient Care STDS. 2014;28:622–7.CrossRefPubMedPubMedCentral
17.
Gilmore HJ, Liu A, Koester KA, et al. Participant experiences and facilitators and barriers to pill use among men who have sex with men in the iPrEx pre-exposure prophylaxis trial in San Francisco. AIDS Patient Care STDS. 2013;27:560–6.CrossRefPubMedPubMedCentral
18.
Wade Taylor S, Mayer KH, Elsesser SM, Mimiaga MJ, O’Cleirigh C, Safren SA. Optimizing content for pre-exposure prophylaxis (PrEP) counseling for men who have sex with men: perspectives of PrEP users and high-risk PrEP naive men. AIDS Behav. 2014;18:871–9.CrossRefPubMedPubMedCentral
19.
Corneli A, Perry B, Agot K, Ahmed K, Malamatsho F, Van Damme L. Facilitators of adherence to the study pill in the FEM-PrEP clinical trial. PLoS One 2015; 10.
20.
Corneli A, Wang M, Agot K, et al. Perception of HIV risk and adherence to a daily, investigational pill for HIV prevention in FEM-PrEP for the FEM-PrEP study group. J Acquir Immune Defic Syndr. 2014;67:555–63.CrossRefPubMed
21.
Toledo L, McLellan-Lemal E, Henderson FL, Kebaabetswe PM. Knowledge, attitudes, and experiences of HIV pre-exposure prophylaxis (PrEP) trial participants in Botswana. World J. AIDS. 2015;5:10–20.CrossRefPubMedPubMedCentral
22.
Carballo-Diéguez A, Giguere R, Dolezal C, et al. Rectal-specific microbicide applicator: evaluation and comparison with a vaginal applicator used rectally. AIDS Behav. 2014;18:1734–45.CrossRefPubMedPubMedCentral
23.
Carballo-Diéguez A, Balán IC, Brown III W, et al. High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women. PLoS One 2017;12(7):e0181607.CrossRefPubMedPubMedCentral
24.
25.
Giguere R, Carballo-Diéguez A, Ventuneac A, et al. Variations in microbicide gel acceptability among young women in the USA and Puerto Rico. Cult Health Sex. 2011;14:151–66.CrossRefPubMedPubMedCentral
26.
Carballo-Diéguez A, Giguere R, Dolezal C, et al. Preference of oral tenofovir disoproxil fumarate/emtricitabine versus rectal tenofovir reduced-glycerin 1% gel regimens for HIV prevention among cisgender men and transgender women who engage in receptive anal intercourse with men. AIDS Behav (under review).
27.
Brown III W, Giguere R, Ibitoye M, Carballo-Diéguez A, Cranston RD. Successfully addressing challenges to implementing a multinational SMS-based reminder and data collection system in a biomedical HIV prevention trial. AIDS Res Hum Retroviruses. 2014;30(S1):A87.
28.
Brown III W, Giguere R, Sheinfil A, et al. Feasibility and acceptability of an international SMS text message-based adherence and survey system in a biomedical HIV prevention study (MTN-017). AIDS Res Hum Retroviruses. 2016;32(S1):386.
29.
Cranston RD, Lama JR, Richardson BA, et al. MTN-017: a rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel. Clin Infect Dis. 2017;64(5):614-20.PubMed
30.
31.
Thomas DR. A general inductive approach for analyzing qualitative evaluation data. Am. J. Eval. 2006;27:237–46.CrossRef
32.
Shieh E, Weld E, Fuchs E, et al. Lubricant provides poor rectal mucosal HIV coverage. AIDS Res Hum Retroviruses 2017 (in press).
33.
34.
Metadata
Title
Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial
Authors
Rebecca Giguere
Christine Tagliaferri Rael
Alan Sheinfil
Ivan C. Balán
William Brown III
Titcha Ho
Curtis Dolezal
Cheng-Shiun Leu
Albert Liu
Kenneth H. Mayer
Javier R. Lama
Ian McGowan
Alex Carballo-Diéguez
Ross D. Cranston
on behalf of the MTN-017 Protocol Team
Publication date
01-02-2018
Publisher
Springer US
Published in
AIDS and Behavior / Issue 2/2018
Print ISSN: 1090-7165
Electronic ISSN: 1573-3254
DOI
https://doi.org/10.1007/s10461-017-1890-7

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