1. 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

2. 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)

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

4. 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

5. 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

6. 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).

7. 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.

8. 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.

9. 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

10. 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

11. 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.”

12. 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%)

13. 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.”

14. 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.”

15. 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.”

16. 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.”

17. 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

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

19. 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

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

21. 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

22. Questions?