1. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Alex Carballo-Diéguez, Ph.D. Columbia University, NYC, US

2. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 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)

3. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 “How frequently would YMSM with a history of condomless RAI apply a gel prior to RAI in their everyday lives?”

4. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 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

5. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 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

6. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Mean (SD)Range Age23.2 years (3.2)18-30 Education 1 4.6 (1.1)2-7 N% Race/Ethnicity White/European American3436% Latino/Hispanic4648% Black/African American910% Mixed/Other66% Sexual identity self-label Gay/Homosexual8186% Bisexual1314% 1 Measured on a 7-point scale (4=partial college).

7. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 N=95 1 BaselineFollow-up Median; Range t (df)p Number of male partners 2 3; 1-702; 0-403.82(92)<.001 Frequency of receptive anal intercourse (RAI) 2 7; 1-9212; 0-70ns Frequency of unprotected RAI (URAI) 2 3; 1-952; 0-602.96(92).004 N(%) Had URAI with partner of serodiscordant or unknown status 29 (31%) 1 Some variables have missing data; percentages are of those with non-missing data. 2 Variables log-transformed prior to t-tests due to skewed distributions.

8. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013

9. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 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

10. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Correlated factors – Liking the gel – Sexual enjoyment with gel – Positive partner reaction to gel – Likelihood of future use of gel if effective

11. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 97% felt gel made RAI feel better or not different 37% better 60% no difference 3% worse 76% felt penetration was easier with gel “It provided better lubrication inside of the rectum than regular lubricant usage.”

12. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 N(%) I did not have the gel with me34 (85%) I forgot19 (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 4 (10%) I did not like how the gel felt inside me 2 ( 5%)

13. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 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.”

14. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 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.”

15. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 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.”

16. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 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.”

17. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Rectal Microbicide Applicator 12.6 cm long 2.6 cm barrel diameter 0.5 cm tip circumference Vaginal Microbicide Applicator 11.9 cm long 1.5 cm barrel diameter 4.1 cm tip circumference Photo courtesy of: Microbicide Trials Network, University of Pittsburgh and Magee-Womens Research Institute

18. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Ethnically diverse young MSM with a history of unprotected RAI showed high adherence to gel use. Different self-report methods provided convergent results.

19. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 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

20. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 A product of known efficacy could have different uptake than the placebo used in this study.

21. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Rebecca Giguere 1 José Bauermeister 2 Curtis Dolezal 1 Timothy Frasca 1 Cheng-Shiun Leu 1 NICHD Juan Valladares 1 Irma Febo 3 Ross Cranston 4 Kenneth Mayer 5 Ian McGowan 4 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

22. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 ac72@columbia.edu