Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1785024288241221632 |
---|---|
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. |
format | Online Article Text |
id | pubmed-10096248 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT bauermeisterjosea arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT dominguezislasclara arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT jiaoyuqing arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT tinglerryan arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT brownelizabeth arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT zemanekjillian arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT giguererebecca arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT balanivan arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT johnsonsherri arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT macagnanicole arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT lucasjonathan arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT rosematthew arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT jacobsoncindy arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT collinsclare arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT livantedward arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT singhdevika arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT hoken arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT hoesleycraig arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT liualbert arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT kayangenoel arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT palaneephillipsthesla arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT chariyalertsaksuwat arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT gonzalespedro arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT piperjeanna arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT arandomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT bauermeisterjosea randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT dominguezislasclara randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT jiaoyuqing randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT tinglerryan randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT brownelizabeth randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT zemanekjillian randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT giguererebecca randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT balanivan randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT johnsonsherri randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT macagnanicole randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT lucasjonathan randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT rosematthew randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT jacobsoncindy randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT collinsclare randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT livantedward randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT singhdevika randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT hoken randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT hoesleycraig randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT liualbert randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT kayangenoel randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT palaneephillipsthesla randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT chariyalertsaksuwat randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT gonzalespedro randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT piperjeanna randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 AT randomizedtrialofsafetyacceptabilityandadherenceofthreerectalmicrobicideplaceboformulationsamongyoungsexualandgenderminoritieswhoengageinreceptiveanalintercoursemtn035 |