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Rectal-Specific Microbicide Applicator: Evaluation and Comparison with a Vaginal Applicator Used Rectally

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Abstract

An applicator designed for rectal delivery of microbicides was tested for acceptability by 95 young men who have sex with men, who self-administered 4 mL of placebo gel prior to receptive anal intercourse over 90 days. Subsequently, 24 of the participants self-administered rectally 4 mL of tenofovir or placebo gel over 7 days using a vaginal applicator, and compared both applicators on a Likert scale of 1–10, with 10 the highest rating. Participants reported high likelihood to use either applicator in the future (mean scores 9.3 and 8.8 respectively, p = ns). Those who tested both liked the vaginal applicator significantly more than the rectal applicator (7.8 vs. 5.2, p = 0.003). Improvements in portability, conspicuousness, aesthetics, tip comfort, product assembly and packaging were suggested for both. This rectal-specific applicator was not superior to a vaginal applicator. While likelihood of future use is reportedly high, factors that decrease acceptability may erode product use over time in clinical trials. Further attention is needed to develop user-friendly, quick-acting rectal microbicide delivery systems.

Resumen

Un aplicador diseñado para administrar los microbicidas rectales fue probado para determinar su aceptabilidad por 95 hombres jóvenes que tienen sexo con hombres, quienes auto-administraron 4 mL de un gel placebo antes del sexo anal receptivo durante 90 días. Posteriormente, 24 de los participantes auto-administraron rectalmente 4 mL de un gel tenofovir o placebo durante 7 días usando un aplicador vaginal, y compararon ambos aplicadores en una escala Likert de 1 a 10, 10 siendo la calificación más alta. Los participantes reportaron alta probabilidad de usar cualquiera de los dos aplicadores en el futuro (calificación media 9.3 y 8.8, respectivamente, p = ns). A los que probaron ambos les gustó significativamente más el aplicador vaginal que el rectal (7.8 vs. 5.2, p = 0.003). Se dieron sugerencias para mejorar la portabilidad, visibilidad, estética, comodidad de la punta, ensamblaje y embalaje de ambos aplicadores. Este aplicador específicamente para uso rectal no fue superior al aplicador vaginal. Aunque se reportó una alta probabilidad de uso en el futuro, los factores que disminuyen la aceptabilidad podrían afectar el uso del producto con el tiempo en los ensayos clínicos. Se necesita enfocar más atención en el desarrollo de sistemas de administración de microbicidas rectales que sean fáciles de usar y rápidas.

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References

  1. Carballo-Diéguez A, Stein Z, Sáez H, Dolezal C, Nieves-Rosa L, Díaz F. Frequent use of lubricants for anal sex among men who have sex with men: the HIV prevention potential of a microbicidal gel. Am J Public Health. 2000;90(7):1117–21.

    Article  PubMed Central  PubMed  Google Scholar 

  2. Gorbach PM, Weiss RE, Fuchs E, Jeffries RA, Hezerah M, Brown S, et al. The slippery slope: lubricant use and rectal sexually transmitted infections: a newly identified risk. Sex Transm Dis. 2012;39(1):59–64.

    Article  PubMed Central  PubMed  Google Scholar 

  3. Javanbakht M, Murphy R, Gorbach P, LeBlanc M-A, Pickett J. Preference and practices relating to lubricant use during anal intercourse: implications for rectal microbicides. Sex Health. 2010;7(2):193–8.

    Article  PubMed  Google Scholar 

  4. Gross M, Celum CL, Tabet SR, Kelly CW, Coletti AS, Chesney MA. Acceptability of a bioadhesive nonoxynol-9 gel delivered by an applicator as a rectal microbicide. Sex Transm Dis. 1999;26(10):572–8.

    Article  CAS  PubMed  Google Scholar 

  5. Anton PA, Saunders T, Elliott J, Khanukhova E, Dennis R, Adler A, et al. First phase 1 double-blind, placebo-controlled, randomized rectal microbicide trial using UC781 gel with a novel index of ex vivo efficacy. PLoS One. 2011;6(9):e23243.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  6. Ventuneac A, Carballo-Diéguez A, McGowan I, Dennis R, Adler A, Khanukhova E, et al. Acceptability of UC781 gel as a rectal microbicide among HIV-uninfected women and men. AIDS Behav. 2010;14(3):618–28.

    Article  PubMed Central  PubMed  Google Scholar 

  7. Pines HA, Gorbach PM, Weiss RE, Hess K, Murphy R, Saunders T, et al. Acceptability of potential rectal microbicide delivery systems for HIV prevention: a randomized crossover trial. AIDS Behav. 2013;17(3):1002–15.

    Article  PubMed Central  PubMed  Google Scholar 

  8. Mabragaña M, Carballo-Diéguez A, Giguere R. Young women’s experience with using videoconferencing for the assessment of sexual behavior and microbicide use. Telemed J E. 2013;19(11):866–71.

    Google Scholar 

  9. MacQueen KM, McLellan E, Kay K, Milstein B. Codebook development for team-based qualitative analysis. Cult Anthropol Methods. 1998;10(2):31–6.

    Google Scholar 

  10. NVivo qualitative data analysis software; QSR International Pty Ltd. Version 8. 2008.

  11. Patton MQ. Qualitative research and evaluation methods. 3rd ed. Thousand Oaks: Sage; 2002.

    Google Scholar 

  12. Carballo-Diéguez A, Giguere R, Dolezal C, Bauermeister J, Leu C-S, Valladares J, Frasca T, Labbett R, Cranston RD, Febo I, Mayer K, McGowan I. Adherence to rectal gel use among mainly ethnic minority young men who have sex with men during a 3-month placebo gel trial: implications for microbicide research. AIDS Behav. 2014. doi:10.1007/s10461-014-0768-1

  13. McGowan I, Hoesley C, Cranston RD, Andrew P, Janocko L, Dai JY, et al. A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1 % gel (MTN-007). PLoS One. 2013;8(4):e60147.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  14. Pfister HR, Böhm G. The multiplicity of emotions: a framework of emotional functions in decision making. Judgm Decis Mak. 2008;3(1):5–17.

    Google Scholar 

  15. Carballo-Diéguez A, Dolezal C, Bauermeister JA, O’Brien W, Ventuneac A, Mayer K. Preference for gel over suppository as delivery vehicle for a rectal microbicide: results of a randomised, crossover acceptability trial among men who have sex with men. Sex Transm Infect. 2008;84(6):483–7.

    Article  PubMed Central  PubMed  Google Scholar 

  16. Van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, et al. Women’s experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa. PLoS One. 2014;9(2):e89118.

    Article  PubMed Central  PubMed  Google Scholar 

  17. Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, et al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir emtricitabine, or vaginal tenofovir gel in the VOICE Study (MTN 003). Atlanta: Sage; 2013.

    Google Scholar 

Download references

Acknowledgments

We would like to thank the panel of experts that helped us during the original development of our rectal applicator. They are Drs. Peter Anton, Pamina Gorbach, Craig Hendrix, Ken Mayer, Ian McGowan, and Tom Moench, as well as activists in this field, Ms. Anna Forbes and Mr. Jim Pickett. We would also like to thank Jessica Cohen from PATH and Dr. Ana Ventuneac (formerly from HIV Center for Clinical and Behavioral Studies) for their collaboration in early stages of this study and all study volunteers without whom this project would not have been feasible. This research was sponsored by the US National Institutes of Health (NIH), including NICHD and NIMH, under R01 HD59533 (McGowan and Carballo-Diéguez, Co-PIs) and co-sponsored by CONRAD. Rectal applicator development was sponsored by the Foundation for AIDS Research (amfAR Research Grant # 106765-41-RGMC; Carballo-Diéguez, PI). 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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Authors and Affiliations

  1. HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, Unit 15, 1051 Riverside Drive, New York, NY, 10032, USA

    Alex Carballo-Diéguez, Rebecca Giguere, Curtis Dolezal, Cheng-Shiun Leu & Juan Valladares

  2. Health Behavior & Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA

    José Bauermeister

  3. Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA

    Lisa C. Rohan

  4. Department of Medicine, Center for HIV Prevention Research, UCLA AIDS Institute, David Geffen School, University of Medicine at UCLA, Los Angeles, CA, USA

    Peter A. Anton

  5. Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA

    Ross D. Cranston

  6. Department of Pediatrics, Gama Project, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA

    Irma Febo

  7. Fenway Health, The Fenway Institute, Boston, MA, USA

    Kenneth Mayer

  8. Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh and the Center for Family Planning Research, Magee-Womens Research Institute, Pittsburgh, PA, USA

    Ian McGowan

Authors
  1. Alex Carballo-Diéguez
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  2. Rebecca Giguere
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  3. Curtis Dolezal
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  4. José Bauermeister
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  5. Cheng-Shiun Leu
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  6. Juan Valladares
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  7. Lisa C. Rohan
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  8. Peter A. Anton
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  9. Ross D. Cranston
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  10. Irma Febo
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  11. Kenneth Mayer
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  12. Ian McGowan
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Correspondence to Alex Carballo-Diéguez.

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Carballo-Diéguez, A., Giguere, R., Dolezal, C. et al. Rectal-Specific Microbicide Applicator: Evaluation and Comparison with a Vaginal Applicator Used Rectally. AIDS Behav 18, 1734–1745 (2014). https://doi.org/10.1007/s10461-014-0793-0

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  • DOI: https://doi.org/10.1007/s10461-014-0793-0

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