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Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men

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Abstract

Oral pre-exposure prophylaxis (PrEP) can prevent HIV transmission. Yet, some may prefer not to take systemic daily medication. MTN-017 was a 3-period, phase 2 safety and acceptability study of microbicide gel applied rectally either daily or before and after receptive anal intercourse (RAI), compared to daily oral tablet. At baseline, cisgender men and transgender women who reported RAI (N = 187) rated the daily oral regimen higher in overall liking, ease of use, and likelihood of future use than the gel regimens. After trying all three, 28% liked daily oral the least. Gel did not affect sexual enjoyment (88%) or improved it (7–8%). Most partners had no reaction to gel use. Ease of gel use improved significantly between the first and the last few times of daily use. A rectal gel used before and after RAI may constitute an attractive alternative to daily tablet. Experience with product use may increase acceptability.

Resumen

La profilaxis pre-exposición oral (PrEP) puede prevenir la transmisión del VIH. Sin embargo, algunos individuos pueden preferir no tomar un medicamento sistémico diariamente. MTN-017 fue una investigación fase dos con tres períodos para evaluar la seguridad y aceptabilidad de un gel microbicida aplicado por vía rectal, ya sea diariamente o antes y después del sexo anal receptivo (SAR), comparado con una tableta oral diaria. Al inicio del estudio, los participantes hombres y mujeres transgénero que reportaron SAR (N = 187) dieron calificaciones más altas al régimen oral diario que a los regímenes de gel en cuanto a agrado en general, facilidad de uso, y probabilidad de uso futuro. Pero después de probar los tres regímenes, a 28% de los participantes le gustó menos la tableta diaria. El gel o bien no afectó al placer sexual (88%) o lo mejoró (7-8%). La mayoría de las parejas no tuvo ninguna reacción al uso del gel. La facilidad del uso del gel mejoró significativamente entre los primeros y los últimos usos del gel diario. Un gel rectal usado antes y después del SAR puede ser una alternativa atractiva a una tableta diaria. La experiencia con el uso del producto puede mejorar la aceptabilidad.

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Acknowledgements

We would like to thank the study participants for their participation and dedication and 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.

Disclaimer

The content is solely the responsibility of the authors and does not necessary represent the official views of the National Institute of Health. The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors’ affiliated institutions. Use of trade names is for identification only and does not imply endorsement by the Public Health Service or by the U.S. Department of Health and Human Services.

Funding

The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health, to the Microbicide Trials Network. The HIV Center for Clinical and Behavioral Studies is funded by NIH Center grant P30 MH43520 (PI: Remien). William Brown III was supported by the National Library of Medicine (R01-LM012355-01A1, PI: Schillinger; and T15-LM007079, PI: Hripcsak), National Institute of Mental Health (P60-MD006902, PI: Bibbins-Domingo).

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Correspondence to Alex Carballo-Diéguez.

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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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Informed consent was obtained from all individual participants included in the study.

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Carballo-Diéguez, A., Giguere, R., Dolezal, C. et al. Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men. AIDS Behav 21, 3336–3345 (2017). https://doi.org/10.1007/s10461-017-1969-1

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