Alex Carballo-Diéguez, Ph.D. Columbia University, NYC, US Adherence to Rectal Microbicide Use Among Mainly Ethnic Minority Young MSM: Lessons from a 3-month Placebo Gel Trial at 3 US sites Alex Carballo-Diéguez, Ph.D. Columbia University, NYC, US

Background In the USA, young men who have sex with men (YMSM), especially those who are ethnic minorities, have high prevalence and incidence of HIV Many report inconsistent condom use for receptive anal intercourse (RAI) Rectal microbicides (RM) could be an alternative if if efficacious and consistently used (adherence)

Research question “How frequently would YMSM with a history of condomless RAI apply a gel prior to RAI in their everyday lives?”

Study Procedures We recruited MSM ages 18-30 in 3 USA sites Baseline assessment of sexual risk behavior Delivery of 40 applicators prefilled with 4mL HEC (hydroxyethylcellulose) gel Applicators to be used within 90 minutes prior to RAI over 12 weeks Follow up interview at week 12

3 measures of sexual behavior and gel use Interactive Voice Response System (IVRS) to report RAI and gel use weekly Used and unused applicators returned to clinic at 6 and 12 weeks Web-based CASI completed at the end of 12 weeks with questions on gel use with RAI

Participant Demographics N=95 Mean (SD) Range Age 23.2 years (3.2) 18-30 Education1 4.6 (1.1) 2-7 N % Race/Ethnicity White/European American 34 36% Latino/Hispanic 46 48% Black/African American 9 10% Mixed/Other 6 6% Sexual identity self-label Gay/Homosexual 81 86% Bisexual 13 14% 1 Measured on a 7-point scale (4=partial college).

Sexual Behavior prior 3 months Baseline Follow-up Median; Range t (df) p Number of male partners 2 3; 1-70 2; 0-40 3.82(92) <.001 Frequency of receptive anal intercourse (RAI) 2 7; 1-92 12; 0-70 ns Frequency of unprotected RAI (URAI) 2 3; 1-95 2; 0-60 2.96(92) .004 N(%) Had URAI with partner of serodiscordant or unknown status 29 (31%) 1Some variables have missing data; percentages are of those with non-missing data. 2 Variables log-transformed prior to t-tests due to skewed distributions.

Discrepancy of gel use measures The measure of applicators used collected from different places did not have a spread of more than 5 applicators, 20% 6-10, remainder 11 or more.

Gel use during sex Overall, participants used gel on about 4 out of 5 RAI occasions Based on CASI (N=83): Median 12 occasions RAI 82.4% adherence to gel use with RAI Based on IVRS (N=88) Median 10.5 occasions RAI 87.9% adherence to gel use with RAI

Factors associated with adherence Correlated factors Liking the gel Sexual enjoyment with gel Positive partner reaction to gel Likelihood of future use of gel if effective

Sexual enjoyment 97% felt gel made RAI feel better or not different 60% no difference 3% worse 76% felt penetration was easier with gel “It provided better lubrication inside of the rectum than regular lubricant usage.”

Reasons for not using the gel (n=40) I did not have the gel with me 34 (85%) I forgot 19 (48%) I did not want to use the gel 5 (13%) My sexual partner did not want me to use the gel 4 (10%) The gel was messy I did not like how the gel felt inside me 2 ( 5%)

Reasons for not using gel Not having gel on hand “I forgot the stuff at home, and I had sex, like it was an unexpected one. That’s why I couldn’t use it.” “I was just waking up and the gel was in another room and my partner wanted to have sex right away.”

Reasons for not using gel Forgetting “I had the gel with me in the same room, I was ready to use it and we got into foreplay, and by the time we were having anal sex I forgot about the gel.”

Reasons for not using gel Problems with discreet usage/not wanting to use gel “Some of the time I didn’t want to tell someone that I had to use it, and I wasn’t able to discreetly use it.” “[The partner] was from online, but I didn’t just feel comfortable using that with him. I just thought it would be weird to just whip that out.”

Reasons for not using the gel Applicator portability/not having gel on hand “It was not something planned. So, the gel was not on hand…I’m not going to put that syringe in my pocket just in case something happens.”

Microbicide Gel Applicators Photo courtesy of: Microbicide Trials Network, University of Pittsburgh and Magee-Womens Research Institute Vaginal Microbicide Applicator 11.9 cm long 1.5 cm barrel diameter 4.1 cm tip circumference Rectal Microbicide Applicator 12.6 cm long 2.6 cm barrel diameter 0.5 cm tip circumference

Conclusions Ethnically diverse young MSM with a history of unprotected RAI showed high adherence to gel use. Different self-report methods provided convergent results.

Recommendations Adherence to product use could potentially be enhanced by: improving portability improving motivation and partner negotiation skills and facilitating the development of routines to counteract forgetfulness

Limitations A product of known efficacy could have different uptake than the placebo used in this study.

Acknowledgements Rebecca Giguere1 José Bauermeister2 Curtis Dolezal1 Timothy Frasca1 Cheng-Shiun Leu1 NICHD Juan Valladares1 Irma Febo3 Ross Cranston4 Kenneth Mayer5 Ian McGowan4 1 Columbia University and NY State Psychiatric Institute, New York, NY USA 2 University of Michigan School of Public Health, Ann Arbor, MI USA 3 University of Puerto Rico Medical Sciences Campus, San Juan, PR USA 4 University of Pittsburgh School of Medicine, Pittsburgh, PA USA 5 The Fenway Institute, Fenway Health, Boston, MA USA

Questions? ac72@columbia.edu