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A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035)

Efforts to develop a range of HIV prevention products that can serve as behaviorally congruent viable alternatives to consistent condom use and oral pre-exposure prophylaxis (PrEP) remain crucial. MTN-035 was a randomized crossover trial seeking to evaluate the safety, acceptability, and adherence t...

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Autores principales: Bauermeister, Jose A., Dominguez Islas, Clara, Jiao, Yuqing, Tingler, Ryan, Brown, Elizabeth, Zemanek, Jillian, Giguere, Rebecca, Balan, Ivan, Johnson, Sherri, Macagna, Nicole, Lucas, Jonathan, Rose, Matthew, Jacobson, Cindy, Collins, Clare, Livant, Edward, Singh, Devika, Ho, Ken, Hoesley, Craig, Liu, Albert, Kayange, Noel, Palanee-Phillips, Thesla, Chariyalertsak, Suwat, Gonzales, Pedro, Piper, Jeanna
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10096248/
https://www.ncbi.nlm.nih.gov/pubmed/37043527
http://dx.doi.org/10.1371/journal.pone.0284339
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author Bauermeister, Jose A.
Dominguez Islas, Clara
Jiao, Yuqing
Tingler, Ryan
Brown, Elizabeth
Zemanek, Jillian
Giguere, Rebecca
Balan, Ivan
Johnson, Sherri
Macagna, Nicole
Lucas, Jonathan
Rose, Matthew
Jacobson, Cindy
Collins, Clare
Livant, Edward
Singh, Devika
Ho, Ken
Hoesley, Craig
Liu, Albert
Kayange, Noel
Palanee-Phillips, Thesla
Chariyalertsak, Suwat
Gonzales, Pedro
Piper, Jeanna
author_facet Bauermeister, Jose A.
Dominguez Islas, Clara
Jiao, Yuqing
Tingler, Ryan
Brown, Elizabeth
Zemanek, Jillian
Giguere, Rebecca
Balan, Ivan
Johnson, Sherri
Macagna, Nicole
Lucas, Jonathan
Rose, Matthew
Jacobson, Cindy
Collins, Clare
Livant, Edward
Singh, Devika
Ho, Ken
Hoesley, Craig
Liu, Albert
Kayange, Noel
Palanee-Phillips, Thesla
Chariyalertsak, Suwat
Gonzales, Pedro
Piper, Jeanna
author_sort Bauermeister, Jose A.
collection PubMed
description Efforts to develop a range of HIV prevention products that can serve as behaviorally congruent viable alternatives to consistent condom use and oral pre-exposure prophylaxis (PrEP) remain crucial. MTN-035 was a randomized crossover trial seeking to evaluate the safety, acceptability, and adherence to three placebo modalities (insert, suppository, enema) prior to receptive anal intercourse (RAI). If participants had no RAI in a week, they were asked to use their assigned product without sex. We hypothesized that the modalities would be acceptable and safe for use prior to RAI, and that participants would report high adherence given their behavioral congruence with cleansing practices (e.g., douches and/or enemas) and their existing use to deliver medications (e.g., suppositories; fast-dissolving inserts) via the rectum. Participants (N = 217) were sexual and gender minorities enrolled in five different countries (Malawi, Peru, South Africa, Thailand, and the United States of America). Mean age was 24.9 years (range 18–35 years). 204 adverse events were reported by 98 participants (45.2%); 37 (18.1%) were deemed related to the study products. The proportion of participants reporting “high acceptability” was 72% (95%CI: 65% - 78%) for inserts, 66% (95%CI: 59% - 73%) for suppositories, and 73% (95%CI: 66% - 79%) for enemas. The proportion of participants reporting fully adherent per protocol (i.e., at least one use per week) was 75% (95%CI: 69% - 81%) for inserts, 74% (95%CI: 68% - 80%) for suppositories, and 83% (95%CI: 77% - 88%) for enemas. Participants fully adherent per RAI-act was similar among the three products: insert (n = 99; 58.9%), suppository (n = 101; 58.0%) and enema (n = 107; 58.8%). The efficacy and effectiveness of emerging HIV prevention drug depends on safe and acceptable delivery modalities that are easy to use consistently. Our findings demonstrate the safety and acceptability of, and adherence to, enemas, inserts, and suppositories as potential modalities through which to deliver a rectal microbicide.
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spelling pubmed-100962482023-04-13 A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035) Bauermeister, Jose A. Dominguez Islas, Clara Jiao, Yuqing Tingler, Ryan Brown, Elizabeth Zemanek, Jillian Giguere, Rebecca Balan, Ivan Johnson, Sherri Macagna, Nicole Lucas, Jonathan Rose, Matthew Jacobson, Cindy Collins, Clare Livant, Edward Singh, Devika Ho, Ken Hoesley, Craig Liu, Albert Kayange, Noel Palanee-Phillips, Thesla Chariyalertsak, Suwat Gonzales, Pedro Piper, Jeanna PLoS One Research Article Efforts to develop a range of HIV prevention products that can serve as behaviorally congruent viable alternatives to consistent condom use and oral pre-exposure prophylaxis (PrEP) remain crucial. MTN-035 was a randomized crossover trial seeking to evaluate the safety, acceptability, and adherence to three placebo modalities (insert, suppository, enema) prior to receptive anal intercourse (RAI). If participants had no RAI in a week, they were asked to use their assigned product without sex. We hypothesized that the modalities would be acceptable and safe for use prior to RAI, and that participants would report high adherence given their behavioral congruence with cleansing practices (e.g., douches and/or enemas) and their existing use to deliver medications (e.g., suppositories; fast-dissolving inserts) via the rectum. Participants (N = 217) were sexual and gender minorities enrolled in five different countries (Malawi, Peru, South Africa, Thailand, and the United States of America). Mean age was 24.9 years (range 18–35 years). 204 adverse events were reported by 98 participants (45.2%); 37 (18.1%) were deemed related to the study products. The proportion of participants reporting “high acceptability” was 72% (95%CI: 65% - 78%) for inserts, 66% (95%CI: 59% - 73%) for suppositories, and 73% (95%CI: 66% - 79%) for enemas. The proportion of participants reporting fully adherent per protocol (i.e., at least one use per week) was 75% (95%CI: 69% - 81%) for inserts, 74% (95%CI: 68% - 80%) for suppositories, and 83% (95%CI: 77% - 88%) for enemas. Participants fully adherent per RAI-act was similar among the three products: insert (n = 99; 58.9%), suppository (n = 101; 58.0%) and enema (n = 107; 58.8%). The efficacy and effectiveness of emerging HIV prevention drug depends on safe and acceptable delivery modalities that are easy to use consistently. Our findings demonstrate the safety and acceptability of, and adherence to, enemas, inserts, and suppositories as potential modalities through which to deliver a rectal microbicide. Public Library of Science 2023-04-12 /pmc/articles/PMC10096248/ /pubmed/37043527 http://dx.doi.org/10.1371/journal.pone.0284339 Text en https://creativecommons.org/publicdomain/zero/1.0/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 (https://creativecommons.org/publicdomain/zero/1.0/) public domain dedication.
spellingShingle Research Article
Bauermeister, Jose A.
Dominguez Islas, Clara
Jiao, Yuqing
Tingler, Ryan
Brown, Elizabeth
Zemanek, Jillian
Giguere, Rebecca
Balan, Ivan
Johnson, Sherri
Macagna, Nicole
Lucas, Jonathan
Rose, Matthew
Jacobson, Cindy
Collins, Clare
Livant, Edward
Singh, Devika
Ho, Ken
Hoesley, Craig
Liu, Albert
Kayange, Noel
Palanee-Phillips, Thesla
Chariyalertsak, Suwat
Gonzales, Pedro
Piper, Jeanna
A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035)
title A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035)
title_full A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035)
title_fullStr A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035)
title_full_unstemmed A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035)
title_short A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035)
title_sort randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (mtn-035)
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10096248/
https://www.ncbi.nlm.nih.gov/pubmed/37043527
http://dx.doi.org/10.1371/journal.pone.0284339
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