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
- 1HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, New York, USA
- 2Fenway Institute, Fenway Community Health, Boston, Massachusetts, USA
- 3Miriam Hospital/Brown University, Providence, Rhode Island, USA
- Dr A Carballo-Diéguez, Unit 15, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA;
- Accepted 25 May 2008
Objective: To assess whether men who have sex with men (MSM) prefer a gel or a suppository as a delivery vehicle for a rectal microbicide.
Methods: 77 HIV-negative MSM with a recent history of inconsistent condom use during receptive anal intercourse (RAI) who acknowledged being at risk of contracting HIV were enrolled in a randomised, crossover acceptability trial. They compared 35 ml placebo gel with 8 g placebo rectal suppositories used on up to three RAI occasions each.
Results: Participants preferred the gel over the suppository (75% versus 25%, p<0.001) and so did their partners (71% versus 29%, p<0.001). The gel received more favourable ratings overall and on attributes such as colour, smell, consistency, feeling in rectum immediately after insertion and/or 30 minutes after insertion and application process. The gel resulted in less negative ratings in terms of participants being bothered by leakage, soiling, bloating, gassiness, stomach cramps, urge to have bowel movement, diarrhoea, pain or trauma. Participants liked the gel more in terms of feelings during anal sex, sexual satisfaction, partners’ sexual satisfaction and liking the product when condoms were used and when condoms were not used.
Conclusions: In this sample taken from one of the populations most likely to benefit from rectal microbicide availability, gel had greater acceptability than a suppository as a potential microbicide vehicle.
Competing interests: None declared.
Ethics approval: Ethics approval was obtained.
Contributors: ACD was the principal investigator of the study and the researcher who took primary responsibility for reporting its results; CD was responsible for data analysis and interpretation; JAB contributed significantly to the writing of the paper and to the interpretation of results; WO’B was the project director of the study and contributed to the writing of the methods section of the manuscript; AV contributed to the implementation of assessment procedures and in the writing of the article; KM was the co-principal investigator of the study and also contributed to the editing of its final report.