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History of Rectal Product Use and Country of Residence Influence Preference for Rectal Microbicide Dosage Forms Among Young Sexual and Gender Minorities: A Multi-country Trial Comparing Placebo Douche, Suppository, and Insert Products

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Abstract

The DESIRE Study (MTN-035) explored product preference among three placebo rectal microbicide (RM) formulations, a rectal douche (RD), a suppository, and an insert, among 210 sexually active transgender people and men who have sex with men in five counties: the United States, Peru, Thailand, South Africa, and Malawi. Participants used each product prior to receptive anal sex (RAS) for 1 month, following a randomly assigned sequence, then selected their preferred product via computer assisted self-interview. In-depth interviews examined reasons for preference. We compared product preference and prior product use by country to explore whether geographic location and experience with the similar products impacted preference. A majority in the United States (56%) and Peru (58%) and nearly half in South Africa (48%) preferred the douche. Most in Malawi (59%) preferred the suppository, while half in Thailand (50%) and nearly half in South Africa (47%) preferred the insert. Participants who preferred the douche described it as quick and easy, already routinized, and serving a dual purpose of cleansing and protecting. Those who preferred the insert found it small, portable, discreet, with quick dissolution. Those who preferred the suppository found the size and shape acceptable and liked the added lubrication it provided. Experience with product use varied by country. Participants with RD experience were significantly more likely to prefer the douche (p = 0.03). Diversifying availability of multiple RM dosage forms can increase uptake and improve HIV prevention efforts globally.

Resumen

El estudio DESIRE (MTN-035) exploró la preferencia de producto entre tres formulaciones de microbicida rectal (MR) de placebo, una ducha rectal, un supositorio y un inserto, entre 210 personas transgénero y hombres que tienen sexo con hombres en cinco países: los Estados Unidos, Perú., Tailandia, Sudáfrica y Malawi. Los participantes utilizaron cada producto antes del sexo anal receptive (SAR) durante un mes, siguiendo una secuencia asignada al azar, luego seleccionaron su producto preferido mediante una autoentrevista asistida por computadora. Las entrevistas en profundidad examinaron los motivos de preferencia. Comparamos la preferencia de producto y el uso previo del producto por país para explorar si la ubicación geográfica y la experiencia con la forma farmacéutica impactaron la preferencia. Una mayoría en los Estados Unidos (56%) y Perú (58%) y casi la mitad en Sudáfrica (48%) prefirieron la ducha rectal. La mayoría en Malawi (59%) prefirió el supositorio, mientras que la mitad en Tailandia (50%) y casi la mitad en Sudáfrica (47%) prefirió el inserto. Los participantes que prefirieron la ducha rectal la describieron como rápida y fácil, ya parte de su rutina y que tenía el doble propósito de limpiar y proteger. Los que prefirieron el inserto lo consideraron pequeño, portátil, discreto y de rápida disolución. Los que prefirieron el supositorio encontraron que tenía un tamaño y forma aceptables y proveía lubricación adicional. La experiencia con el uso del producto varió según el país. Los participantes con experiencia con duchas rectales tenían significativamente más probabilidades de preferir la ducha rectal (p = 0,03). Diversificar la disponibilidad de múltiples formas farmacéuticas de MR puede aumentar la aceptación y mejorar los esfuerzos de prevención del VIH a nivel mundial.

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Acknowledgements

The study team gratefully acknowledges the study participants of MTN-035. We are grateful to the local research teams for their work. We also recognize the contributions of staff across the study sites, and the interviewers for this study, Brigid Allyson, Titcha Ho, and Besta Yotamu. The study was designed and implemented by the Microbicide Trials Network (MTN) funded by the National Institute of Allergy and Infectious Diseases through individual grants (UM1AI068633, UM1AI068615 and UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health (NIMH), all components of the U.S. National Institutes of Health (NIH). This work was also supported by NIMH grants K23MH124569, Principal Investigator: Bryan Kutner, PhD, MPH and P30MH043520, Principal Investigator: Robert Remien, PhD. CONRAD manufactured and provided the inserts for this study with funding from PEPFAR through a cooperative agreement between the USAID and Eastern Virginia Medical School (AID-OAA-A-14-00010) with funding from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or any USG agencies.

Funding

This study was supported by Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (Grant No. UM1AI068633), Division of Intramural Research, National Institute of Allergy and Infectious Diseases (Grant Nos. UM1AI068615, UM1AI106707), National Institute of Mental Health (Grant Nos. K23MH124569, P30MH043520), United States Agency for International Development (Grant No. AID-OAA-A-14-00010).

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Authors and Affiliations

  1. Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Research, New York State Psychiatric Institute and Columbia University, New York, NY, USA

    Rebecca Giguere & Bryan A. Kutner

  2. Center for Translational Behavioral Science, College of Medicine, Florida State University, Tallahassee, FL, USA

    Rebecca Giguere & Iván C. Balán

  3. Psychiatry Research Institute at Montefiore Einstein (PRIME), Albert Einstein College of Medicine, Bronx, NY, USA

    Bryan A. Kutner

  4. University of Pennsylvania, Philadelphia, PA, USA

    Seul Ki Choi, Ryan Tingler, Jessica Webster & José A. Bauermeister

  5. FHI 360, Durham, NC, USA

    Sherri Johnson, Nicole Macagna & Cindy E. Jacobson

  6. Bridge HIV at the San Francisco Department of Public Health, San Francisco, CA, USA

    Al Liu

  7. Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand

    Suwat Chariyalertsak

  8. University of Alabama at Birmingham, Birmingham, AL, USA

    Craig Hoesley

  9. IMPACTA Asociación Civil, Impacta Salud y Educación, San Miguel CES, Lima, Peru

    Pedro Gonzales

  10. University of Pittsburgh Medical Center, Pittsburgh, PA, USA

    Ken Ho

  11. Blanytre CRS, Johns Hopkins University Research Project, Blantyre, Malawi

    Noel Kayange

  12. Wits RHI, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa

    Thesla Palanee-Phillips

  13. Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA

    Thesla Palanee-Phillips

  14. Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Elizabeth Brown & Jillian Zemanek

  15. CONRAD, Eastern Virginia Medical School, Norfolk, VA, USA

    Gustavo F. Doncel

  16. Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA

    Jeanna Piper

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Correspondence to Rebecca Giguere.

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Conflict of interest

AL and TPP have received funding for investigator sponsored research projects from Gilead Sciences. AL has also received research funding from ViiV Healthcare. Gilead Sciences has donated study drug to studies led by AL.

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Giguere, R., Balán, I.C., Kutner, B.A. et al. History of Rectal Product Use and Country of Residence Influence Preference for Rectal Microbicide Dosage Forms Among Young Sexual and Gender Minorities: A Multi-country Trial Comparing Placebo Douche, Suppository, and Insert Products. AIDS Behav (2024). https://doi.org/10.1007/s10461-024-04360-9

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