Gel or Suppositories? Results of a Rectal Microbicide Formulation Preference Trial Alex Carballo-Diéguez 1, Curtis Dolezal 1, Jose A. Bauermeister 1, Ana Ventuneac 1, William O’Brien 2, Kenneth Mayer 2,3 1.HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA 2.Fenway Institute, Fenway Community Health, Boston, MA, USA 3.Miriam Hospital/Brown University, Providence, RI, USA HIV CENTER for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University This research is supported by a grant from NICHD (R ).

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

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

Study Implementation Recruitment:  The Fenway Community Health – Boston, MA  Between May 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.

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

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 Measures

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)

Disliked very much Liked very much Gel Supp COLORSMELLCONSISTENCY

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

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

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

N = 55 N = 22

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

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

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

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

Thank you! Alex Carballo-Diéguez, Ph.D.