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

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, USA3. Miriam Hospital/Brown University, Providence, RI, USA

HIV CENTER for Clinical and Behavioral StudiesHIV CENTER for Clinical and Behavioral Studiesat the New York State Psychiatric Institute and Columbia Universityat the New York State Psychiatric Institute and Columbia University

This research is supported by a grant from NICHD (R01 046060).This research is supported by a grant from NICHD (R01 046060).

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 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.

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)

Dislikedvery much

Likedvery much

GelGel Gel

SuppSupp Supp

COLOR SMELL CONSISTENCY

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/TraumaMovement

▲ Supp

o Gel

Liked very much

Disliked very much

▲ Supp

o Gel

Feeling With Condoms Without Condoms Partner’s sexual satisfaction Overall partner preferenceWith condoms

Without condoms

Partner’s sexual

satisfaction

Sexual Satisfaction

Overall partner

preference

N = 55

N = 22

25% 28%

72%75%

0

10

20

30

40

50

60

70

80

Participant's Product Preference Perceived Partner's Product Preference

Num

ber o

f Par

ticip

ants

(N =

77)

Gel

Suppository

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.ac72@columbia.edu