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
Year: 2017
Type: article
Abstract: 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.
Source: PLoS ONE
Authors: Alex Carballo-Diéguez, Ivan C. Balán, William Brown, Rebecca Giguere, Curtis Dolezal, Cheng-Shiun Leu, Mark A. Marzinke, Craig W. Hendrix, Jeanna M. Piper, Barbra A. Richardson, Cynthia Grossman, Sherri Johnson, Kailazarid Gomez, Stephanie Horn, Ratiya Pamela Kunjara Na Ayudhya, Karen Patterson, Cindy Jacobson, Linda-Gail Bekker, Suwat Chariyalertsak, Anupong Chitwarakorn, Pedro Gonzales, Timothy H. Holtz, Albert Liu, Kenneth H. Mayer, Carmen Zorrilla, Javier Lama, Ian McGowan, Ross D. Cranston
Institutions: New York State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, Columbia University, University of California, San Francisco, Johns Hopkins University, National Institutes of Health, National Institute of Allergy and Infectious Diseases, University of Washington, National Institute of Mental Health, Family Health International 360, Magee-Womens Research Institute, University of Cape Town, Chiang Mai University, Ministry of Public Health, Asociación Civil Impacta Salud y Educación, San Francisco Department of Public Health, University of Puerto Rico, Medical Sciences Campus, University of Puerto Rico System, University of Pittsburgh
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,382
Awards: G1331801309, G1363540049, G1736305949, Statistical and Data Management Center (SDMC): Microbicide Trials Network, Leadership and Operations Center (LOC): Microbicide Trials Network, G326420316, The Next Frontier in Diabetes Communication: Promoting Health Literacy in the Era of Secure Messaging, G398575387, G5004570041, Integrated University of Puerto Rico Clinical Trials Unit, I3DEAL for HIV Research, Laboratory Center (LC): Microbicide Trials Network, G9000063288, G9000346981, Training in Biomedical Informatics at Columbia University, Pitt-Ohio State Clinical Trials Unit, San Francisco Bay Clinical Trials Unit (CTU), Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU), HIV Center for Clinical and Behavioral Studies, Boston HIV CTU
OpenAlex ID: W2742089017