Abstract
We examined young gay, bisexual, and other men who have sex with men’s (YGBMSM) usage patterns of a pre-coital, applicator-administered rectal placebo gel. An ethnically diverse sample of 94 YGBMSM (aged 18–30 years) were asked to insert hydroxyethylcellulose placebo gel rectally before receptive anal intercourse (RAI) and report their gel use through an interactive voice response system (IVRS) across 12 weeks. We used trajectory analyses to characterize participants’ use of the rectal gel over the 12 weeks, and examine whether these trajectories varied based on participants’ sociodemographic characteristics, sexual behaviors, application and insertion behaviors, and experiences using the placebo gel. A cubic model was the best fit for these longitudinal data, with two distinct trajectories of gel use observed. The first trajectory (‘High with Varying Gel Use per Week’) represented YGBMSM (N = 38; 40.3%) who reported using the rectal gel on several occasions per week. The second trajectory (‘Low and Consistent Gel Use per Week’) represented participants (N = 56; 59.7%) who reported a consistent average use of one gel per week. Participants in the High with Varying Gel Use Trajectory reported trying out a greater number of positions when inserting the gel across the 12-weeks than peers in the Low and Consistent Gel Use Trajectory. YGBMSM reporting more RAI occasions during the trial were more likely be present in the High with Varying Gel Use Trajectory than peers in the Low and Consistent Gel Use Trajectory. Future research examining how to facilitate gel application and adherence among YGBMSM is merited.
Resumen
Examinamos los patrones de uso de un gel placebo en una muestra de jóvenes gays, bisexuales y otros hombres que tienen relaciones sexuales con hombres (YGBMSM). Una muestra étnicamente diversa de jóvenes (N = 94; 18 a 30 años) participaron en el estudio, donde se les pidió que insertaran el gel rectalmente antes del coito anal receptivo e informaran su uso a través de un sistema de respuesta interactiva por voz a lo largo de 12 semanas. Utilizamos un análisis de trayectoria para caracterizar el uso del gel rectal durante las 12 semanas y examinar si estas trayectorias variaban según las características sociodemográficas, comportamientos sexuales, comportamientos de aplicación e inserción y experiencias usando el gel placebo de los participantes. Un modelo cúbico se utilizó para estos datos longitudinales; dos trayectorias distintas fueron observadas. La primera trayectoria (‘Alta con uso de gel variable por semana’) representó a participantes (N = 38; 40.3%) quienes usaron el gel rectal en varias ocasiones por semana. La segunda trayectoria (“Uso bajo y consistente del gel por semana”) representó a aquellos participantes (N = 56; 59.7%) caracterizados por un uso promedio y consistente de un gel por semana. Los participantes en la primera trayectoria reportaron haber probado un mayor número de posiciones al insertar el gel a lo largo de las 12 semanas que sus pares en la segunda trayectoria. YGBMSM informando más ocasiones de sexo anal receptivo durante el estudio tuvieron mayor probabilidad de ser clasificados en la primera trayectoria. Estudios que examinen cómo facilitar la aplicación y la adherencia al gel entre YGBMSM ameritan atención en el futuro.
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Acknowledgements
We greatly appreciate the hard work of the study staff at the sites, and are indebted to the study participants for volunteering their time. This research was sponsored by the US National Institutes of Health (NIH), including NICHD and NIMH, under R01 HD59533 (Carballo-Diéguez and McGowan, Co-PIs) and co-sponsored by CONRAD. Additional support came from the National Institute of Mental Health to the HIV Center for Clinical and Behavioral Studies at NY State Psychiatric Institute and Columbia University (P30-MH43520; Principal Investigator: Robert Remien). The content is solely the responsibility of the authors and does not necessarily represent the official views of NIH.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Bauermeister, J.A., Giguere, R., Leu, C.S. et al. Patterns of a Rectal Microbicide Placebo Gel Use in a Preparatory Stage for a Phase I Trial Among Young Men Who Have Sex with Men. AIDS Behav 22, 412–420 (2018). https://doi.org/10.1007/s10461-017-1847-x
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DOI: https://doi.org/10.1007/s10461-017-1847-x