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Original research
Acceptability of a rectal microbicide douche for HIV prevention: a mixed-methods analysis of a first-in-human formulation pilot study
  1. Rebecca Giguere1,
  2. Iván C Balán1,
  3. Cody Lentz2,
  4. Curtis Dolezal1,3,
  5. Alex Carballo-Diéguez3,
  6. Edward J Fuchs4,
  7. Peter Anton5,
  8. Ian McGowan6,
  9. Ken Ho7,
  10. Ethel Weld4,
  11. Craig W Hendrix4
  1. 1Center for Translational Behavioral Science, College of Medicine, Florida State University, Tallahassee, Florida, USA
  2. 2Health Disparities and Prevention Science Lab, Department of Clinical Psychology, Temple University, Philadelphia, Pennsylvania, USA
  3. 3HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, New York State Psychiatric Institute and Columbia University, New York, NY, USA
  4. 4Division of Clinical Pharmacology, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
  5. 5Division of Digestive Disease, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA
  6. 6Orion Biotechnology, Barcelona, Spain
  7. 7Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  1. Correspondence to Rebecca Giguere, Florida State University, Tallahassee, FL 32306, USA; rebecca.giguere{at}med.fsu.edu

Abstract

Objectives DREAM-01 was an open label, dose-escalation and variable osmolarity study to identify a tenofovir HIV-prevention douche/enema that could achieve protective colon tissue cell concentrations and high acceptability. To assess impact on sexual enjoyment, iso-osmolar and hypo-osmolar placebo douches were provided for at-home use before receptive anal sex (RAS).

Methods Eighteen HIV-uninfected men who have RAS were administered three tenofovir douches at the research clinic: Product A, an iso-osmolar dose; Product B, an iso-osmolar escalation dose; and Product C, a hypo-osmolar escalation dose. Following Products A and C, participants were given a saline douche of matching osmolarity to use at home before RAS. Participants reported acceptability via a computer-assisted self-interview and in-depth interview in this mixed-methods study.

Results All three products were rated acceptable by 17 (95%) of the participants. A majority (94%) would be likely or very likely to use any of the three products before RAS. Of those who used the saline douches before RAS and then rated their sexual enjoyment, most reported that their sexual enjoyment was not affected. Interview data revealed that participants found the product easy to incorporate into their regular routine, but would prefer to use more liquid for cleansing.

Conclusions These findings indicate that the hypo-osmolar Product C, which also provides the most rapid delivery of tenofovir for HIV prevention, is acceptable for future safety trials and that our sample reports high likelihood of using a rectal microbicide douche for HIV prevention. Our findings support continued pursuit of a tenofovir rectal microbicide douche.

Trial registration number NCT02750540.

  • HIV
  • Behavioral Sciences
  • Pre-Exposure Prophylaxis
  • Sexual and Gender Minorities
  • SEXUAL HEALTH

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/sextrans-2024-056209

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Handling editor Adam Williams

    • Contributors RG oversaw behavioural data collection, analysis and drafting of the manuscript. ICB contributed to drafting and revising the manuscript. CL collaborated on qualitative data analysis and revising the manuscript. CD oversaw quantitative data analysis and contributed to drafting and reviewing the manuscript. AC-D was the co-investigator leading the behavioural study design and contributed to drafting and revising the manuscript. EJF and EW led the clinical data collection and participant involvement at Johns Hopkins University. PA was a co-investigator who contributed to the clinical study design and data collection at UCLA. IM was a co-investigator who contributed to the clinical study design and oversaw data collection at the University of Pittsburgh. KH led the safety data collection and oversaw participant involvement at the University of Pittsburgh. CWH was the principal investigator who led the study design and oversight. All authors reviewed and approved the manuscript. RG is the guarantor.

    • Funding National Institutes of Health (NIH) Department of Allergy & Infectious Disease, Division of AIDS (DAIDS), Integrated Preclinical/Clinical Program for HIV Topical Microbicides (U19 AI113127), Clinical Pharmacology Training Program (T32 GM066691), Johns Hopkins University Center for AIDS Research (P30AI094189), National Institutes of Health (NIH) National Institute of Mental Health, HIV Center for Clinical and Behavioral Studies (P30-MH43520).

    • Competing interests CWH is contracted through Merck and Gilead for clinical study effort support through Johns Hopkins University. CWH and EJF are inventors at Johns Hopkins Technology Ventures and owners of two issued US patents and one pending patent related to rectal microbicides, through which they receive royalties. CWH and EJF are co-founders of Prionde Biopharma, LLC, a company focused on rectal microbicide development. CWH has also served on data safety monitoring board (DSMB) for MicrobicideTrial Network (MTN) clinical trials of vaginal PrEP products.

    • Provenance and peer review Not commissioned; internally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.