Lessons from a 3month Placebo Gel Trial at 3 US sites Alex CarballoDiéguez PhD 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 ID: 590199
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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, USSlide2
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)Slide3
Research question
“
How
frequently would YMSM with a
history of
condomless
RAI apply
a gel
prior
to
RAI in their everyday lives?
” Slide4
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 12Slide5
3 measures of sexual behavior and gel use
Interactive Voice Response System (IVRS
)
to report
RAI and gel use
weekly
U
sed
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
RAISlide6
Participant Demographics N=95
Mean (SD)
Range
Age
23.2 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).Slide7
Sexual Behavior prior 3 months
N=95
1
Baseline
Follow-up
Median; Range
Median; Range
t (
df
)
p
Number of male partners 23; 1-702; 0-403.82(92)<.001Frequency of receptive anal intercourse (RAI) 27; 1-9212; 0-70nsFrequency of unprotected RAI (URAI) 23; 1-952; 0-602.96(92).004N(%)Had URAI with partner of serodiscordant or unknown status29 (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.Slide8
Discrepancy of gel use measuresSlide9
Gel use during sexOverall, 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 RAISlide10
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
effectiveSlide11
Sexual enjoyment
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.”Slide12
Reasons for not using the gel (n=40)
N(%)
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
4 (10%)I did not like how the gel felt inside me 2 ( 5%)Slide13
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.” Slide14
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.”Slide15
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.”Slide16
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.”Slide17
Microbicide Gel Applicators
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 InstituteSlide18
Conclusions
Ethnically diverse young MSM with a history of unprotected RAI showed
high adherence
to gel use.
Different
self-report methods provided convergent results.Slide19
RecommendationsAdherence to product use could potentially be enhanced
by:
improving
portability
improving
motivation and partner negotiation skills
a
nd facilitating
the development of routines to counteract
forgetfulness Slide20
LimitationsA product of
known efficacy
could have different uptake than the placebo used in this study.Slide21
Acknowledgements
Rebecca Giguere
1
José Bauermeister
2
Curtis Dolezal
1
Timothy Frasca
1
Cheng-
Shiun
Leu1 NICHDJuan Valladares1Irma Febo3Ross Cranston4Kenneth Mayer5Ian McGowan41 Columbia University and NY State Psychiatric Institute, New York, NY USA2 University of Michigan School of Public Health, Ann Arbor, MI USA3 University of Puerto Rico Medical Sciences Campus, San Juan, PR USA4 University of Pittsburgh School of Medicine, Pittsburgh, PA USA5 The Fenway Institute, Fenway Health, Boston, MA USASlide22
Questions?
ac72@columbia.edu