Gel or Suppositories? Results of a Rectal Microbicide Formulation Preference Trial

1. HIV CENTER for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University Gel or Suppositories? Results of a Rectal Microbicide Formulation Preference Trial Alex Carballo-Diéguez1, Curtis Dolezal1, Jose A. Bauermeister1, Ana Ventuneac1, William O’Brien2, Kenneth Mayer2,3 HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA Fenway Institute, Fenway Community Health, Boston, MA, USA Miriam Hospital/Brown University, Providence, RI, USA This research is supported by a grant from NICHD (R01 046060).

2. Acceptability • Microbicides need to be not only efficacious against HIV, but, equally important, products that people are willing and able to use • Placebo trials allow forecasts of the acceptability of different formulations

3. Formulation Preference Trial To compare the relative acceptability of: • Gel (FemGlide) • Dosage: 35 mL • Accordion-shaped enema bottle • Suppository (Rectal Rocket) • Dosage: 8 g • 2.5 inches in length

4. Study Implementation • Recruitment: • The Fenway Community Health – Boston, MA • Between May 2005 - April 2007 • Eligibility Criteria: • 18 years of age or older; • HIV-negative by self-report; • Knowledgeable about HIV-transmission risk; • Reported having had unprotected RAI in the prior year and rated this behavior as involving some risk of HIV transmission to himself; and • Reported having had a male partner with whom he engaged in RAI at least once every two weeks.

5. Procedures • Participants were sequentially randomized to Group A (gel) or Group B (suppository) • Inserted the product at home on 3 separate occasions up to 2 hours prior to RAI • Returned to the clinic to complete an acceptability assessment • Received the second product (Group A, suppository; Group B, gel) • Used the product 3 times • Returned to the clinic to complete an acceptability and preference assessment

6. Measures • Baseline • Demographics • Sexual behavior in previous two months • Intentions to use a rectal microbicide • Follow up • Acceptability ratings: • Product properties • Process of applying products • For those reporting problems (leakage, etc.), how much they were bothered by each problem • Sexual satisfaction with product use • Product preference • Product recommendations

7. Study Sample • 41 years of age (18-60) • Majority had high school education or higher • 62% were employed • $20,001-$40,000 average income • 65% identified as White or European American • 75% identified as gay • Mean number of male partners in prior 2 months: 4.40 • Mean of number of RAI occasions: 9.05 (slightly more than half were unprotected)

8. Liked very much Gel Gel Gel Supp Supp Supp Disliked very much COLOR SMELL CONSISTENCY

9. Liked very much Gel Gel Gel Supp Supp Supp Disliked very much Product Application Feeling Inside Feeling after 30 min

10. Very much Not at all Leakage Soiling Bloating Gassiness Cramps Bowel Diarrhea Pain/Trauma Movement ▲ Supp o Gel

11. Liked very much ▲ Supp o Gel Disliked very much Overall partner preference Partner’s sexual satisfaction Feeling With CondomsWithout Condoms Partner’s sexual satisfaction Overall partner preference Sexual Satisfaction With condoms Without condoms

12. N = 55 N = 22

13. Extremely likely Gel Gel Supp Supp Extremely unlikely Likely to use similar product Likely to use when no condoms

14. Gel was preferred over the suppository • Physical properties (color, smell, consistency) • Ease of application • Feeling inside rectum immediately and after 30 min • Less bothersome problems (leakage, soiling, bloating, gassiness, cramps, diarrhea) • Feeling of product during sex • Sexual satisfaction w/ product, w/ and w/o condoms • Perceived partner sexual satisfaction • Overall partner acceptability

15. However… • Smaller, more compact products would be preferred • Participants did not want to have to wait for the product to become “activated” • Cost should be equal or only slightly more than a condom • Intentionality to use was higher for gel vs. suppository prior to and after the trial

16. Limitations • Smaller suppositories or suppositories with different characteristics (e.g., solubility, mode of application) may result in different acceptability ratings • Neither the gel nor the suppository carried an active ingredient • Small sample size

17. Thank you! Alex Carballo-Diéguez, Ph.D. ac72@columbia.edu