TY - JOUR
T1 - 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
AU - Carballo-Diéguez, Alex
AU - Balán, Ivan C.
AU - Brown, William
AU - Giguere, Rebecca
AU - Dolezal, Curtis
AU - Leu, Cheng Shiun
AU - Marzinke, Mark A.
AU - Hendrix, Craig W.
AU - Piper, Jeanna M.
AU - Richardson, Barbra A.
AU - Grossman, Cynthia
AU - Johnson, Sherri
AU - Gomez, Kailazarid
AU - Horn, Stephanie
AU - Kunjara Na Ayudhya, Ratiya Pamela
AU - Patterson, Karen
AU - Jacobson, Cindy
AU - Bekker, Linda Gail
AU - Chariyalertsak, Suwat
AU - Chitwarakorn, Anupong
AU - Gonzales, Pedro
AU - Holtz, Timothy H.
AU - Liu, Albert
AU - Mayer, Kenneth H.
AU - Zorrilla, Carmen
AU - Lama, Javier
AU - McGowan, Ian
AU - Cranston, Ross D.
N1 - Funding Information:
The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (https://www.niaid.nih.gov/) (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (https://www.nichd.nih.gov) and the National Institute of Mental Health, all components of the U.S. National Institutes of Health (https://www.nimh.nih.gov). The content is solely the responsibility of the authors and does not necessary represent the official views of the National Institute of Health. The HIV Center for Clinical and Behavioral Studies is also supported by NIH Center grant P30 MH43520 (PI: Remien) (https://www.nimh.nih.gov). William Brown III was supported by the NLM (R01-LM012355-01A1 PI: Schillinger; and T15-LM007079, PI: Hripcsak) (https://www.nlm.nih.gov) and the NIMH/NIDA (R03-MH103957, PI: Bakken) (https://www.nimh. nih.gov). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. We are grateful to the study participants for their participation and dedication. 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.
Publisher Copyright:
© 2017, Public Library of Science. All rights reserved. This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.
PY - 2017/7
Y1 - 2017/7
N2 - Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)—if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18–64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ≥80% adherence to daily tablet, 41% having perfect adherence; 83% had ≥80% adherence to daily gel, 29% having perfect adherence; and 93% had ≥80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ≥80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP.
AB - Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)—if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18–64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ≥80% adherence to daily tablet, 41% having perfect adherence; 83% had ≥80% adherence to daily gel, 29% having perfect adherence; and 93% had ≥80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ≥80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP.
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U2 - 10.1371/journal.pone.0181607
DO - 10.1371/journal.pone.0181607
M3 - Article
C2 - 28750059
AN - SCOPUS:85026543507
VL - 12
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 7
M1 - e0181607
ER -