Update on
Rectal Lubricant
Use Research
Pamina M. Gorbach, UCLA
Background
• There has been little research focused on use of and contents
of commercial lubricants
• Lubricants are classified as “medical devices” so not FDA
regulated as drugs; avoid clinical trial testing for safety
• Lubricant use for rectal intercourse very common: 59%
reported always using in large internet survey of 6,124 men
and women reporting AI (Javanbakht J et al 2010)
• 89% reported always using lubricant among US MSM in San
Francisco (Carballo-Dieguez A et al 2007)
Population level assessment of
lubricant risks?
• No known previous epidemiology on rectal lubricant
use and rectal STI
• Understanding of lubricant use and associated risks
important for rectal microbicide development
• Important public health implications: for rectal
health and HIV prevention
Next Steps: After U19 RHB
• Collaboration with Project AWARE: assess of particular types
of lubricant with rectal STI among MSM .
• Funded by UCLA AIDS Institute Seed Grant
• Douching/enema internet survey - Collaboration with IRMA
.
• Funded by UCLA AIDS Institute Seed Grant -
Project AWARE
Aims:
• Identify different lubricant use practices among STD clinic
attendees across the United States. With the collaboration of
the PIs of a large multi-site intervention trial based at 9 STD
clinics throughout the US, we will obtain detailed data on
lubricant use. We will compare types of lubricants used
between the locations and individual characteristics that are
associated with choice of different lubricant types.
• Confirm the association between rectal lubricant use and STI
acquisition through a study of 1,250 men who have sex with
men (MSM). We will analyze associations of lubricant type
and frequency of use with rectal gonorrhea and Chlamydial
infection (rGC/CT).
Web-based Questionnaire for AWARE
•Identified lubricant products reported by US IRMA survey
• respondents: 188 products
•Identified images for each of these for reference sheet for survey
1
11 Wet Light
21 Wet Comfort
Kiwi
Strawberry
Astroglide
Liquid
31 Wet Fun
Flavors
Seductive
Strawberry
32 Wet Synergy
41
Pjur
Superhero
42
Pjur
AnalyseME
2
Astroglide
Gel
12 Wet Platinum
22 Wet Comfort
Sensitive Skin
3
Astroglide
Strawberry
13 Wet
Warming
23 Wet Flavored
Blueberry
33 Wet Synergy
Cool Tingle
43
Pjur
Backdoor
4
Astroglide
Glycerin &
Paraben FREE
14 Wet OilBased
24 Wet Flavored
Cherry
34 Wet
Together
44
KY Jelly
5
Astroglide
Natural
15 Wet
Pheromone
25 Wet Flavored
Kiwi
Strawberry
35 Pjur
Bodyglide
Original
45
KY
Warming
Jelly
6
Astroglide X
Silicone
Lubricant
16 Wet Naturals
26 Wet Flavored
Passion Fruit
36 Pjur
Bodyglide
Light
46
KY Tingling
Jelly
Project AWARE Sample
• Project AWARE: ~ 5,000 individuals seeking medical or health
services from 9 STD clinics in Miami and Jacksonville, Florida,
Columbia, South Carolina, Washington D.C., Pittsburgh,
Pennsylvania, Portland, Oregon, Seattle, Washington, San
Francisco, and Los Angeles, California.
• Participants: 18 years of age or older; and efforts were made
to recruit a sample that reflects the proportion of minorities
and gender in the STD clinic performance sites from which
Project Aware.
• 25% are MSM producing about 1250 eligible participants with
rectal STI results.
• Participants are tested for STIs, queried about their HIV
testing history at baseline and sexual and drug use risk
behaviors at baseline and at 6-month follow-up.
Project AWARE - Background
• We successfully proposed an ancillary study to the Project
AWARE team to create a short online web survey to be filled
out by Project Aware MSM participants that will collect data
on rectal lubricant use.
• The survey will be less than 20 questions and the questions
are based on those used in the proposed PI’s preliminary
study on lubricant use and STIs but will provide more precise
data on the frequency of lubricants used and types of
lubricants.
AWARE: Procedures
• After completing the Project Aware protocol, participants are
offered an opportunity to do the lubricant questionnaire.
• For those who agree study staff open the link to the
questionnaire (Survey Monkey), enter the participant’s ID, and
ask the participant to complete the questionnaire
• Participants are provided a laminated sheet with the names of
over 100 types of lubricants currently available with a small
image of the package in which they are commercially available
and a number code.
• Participants are asked to identify the specific lubricants they
use by these codes and enter them on the questionnaire.
AWARE Analysis
• Describe the frequency of use of lubricants for RAI, the most
frequent category of lubricant subjects use (i.e. water-based
vs. oil based), and within category the brands most often
used.
• Describe characteristics of lubricant users - determine if there
are differences in frequency and category of use by location,
age, race/ethnicity, partner-type, drug use, frequency of sex,
and number of recent sexual partners.
• Primary analysis will be to determine associations between
lubricant use and sexually transmitted infections. Lubricant
users will be categorized by frequency of lubricant used and
types of lubricant used and using bivariate statistics such as
chi-square and Fishers exact test, association with prevalent
rectal gonorrhea, rectal chlamydial infection and active or
acute syphilis.
AWARE Progress
• Over 300 participants already completed lube
questionnaire
• Data should be complete in July 2011 
Next steps: Lubricants and Douches
• About 50% of men report rectal douching or enema use in the
past month AND always use of lubricant products
• Significantly more of those who report always using lubricants
during RAI in the past month report douching in the past
month than do not douche (58% vs 41%; p=.000)
• Now analyzing the association between douching and
lubricant use in U19
• Analyses in process – stay tuned! To be presented in March at
Keystone Conference
New IRMA-UCLA web douching survey
• Funded by UCLA AIDS Institute
• In collaboration with IRMA, we will conduct an internetsurvey of individuals who practice RAI to determine products
used for rectal douching.
• The survey will be modeled after the previous IRMA survey.
Questionnaire will include information about sexual behaviors
surrounding AI and douching and provide an image-based list
of douches available commercially as well as fill-in the blank
questions about content of “home-brew” douches.
• Frequency of use in the past month and 6 months will be
collected as well as duration of douching and timing of
douching. We will also ask about testing for rectal STIs and
history of diagnosis.
UCLA-IRMA Douche Survey
• AIMS:
– To identify the specific content and types of products used
for rectal douching among both men and women,
including both commercial and home-brew products
– To evaluate rectal douching practices and factors
associated with douching comparing the different types of
products used
Douche Survey: Recruitment
• We plan to use a similar recruitment strategy to IRMA lube
survey that was brief email messages with three different
target audiences (general, gay men and MSM, and women)
sent through various topical, regional and community
listservs. listservs included (but were not limited to) those
focused on HIV, microbicides, gay men’s health, women’s
health, and sexual and reproductive health.
• Several websites posted information and links to the survey,
including sites targeted to gay men and rectal microbicides.
Also organizations included notices in their agency newsletter
and websites, and several media outlets wrote articles about
the survey.
Douche Survey: Procedures
• Participants who express interest in the study will be directed
to a page on the IRMA website dedicated to the study. There
a paragraph describing the study and the work of the research
team will be posted with a button to click for those interested
in participation. This button will proceed to an informed
consent page where participants will provide electronic
consent to participate in this anonymous survey. If they
consent, they will proceed to a questionnaire.
• With IRMA’s team of volunteers , we will be able to offer
the survey in multiple languages including English, French,
German, Portuguese, and Spanish.
Douche Survey: Contents
• The questionnaire will be developed with close collaboration
between the UCLA investigators and IRMA team.
• Similar to our previous lubricant survey, the data for the
douching survey will be collected using Survey Monkey and
will be anonymous.
• Frequency of use in the past month and 6 months as well as
timing of douching (i.e., before and/or after sex).
• An image-based list of douches available commercially for
participants to click on the product(s) they have used as well
as fill-in the blank questions about content of “home-brew”
douches. This will allow for a classification of douches used
by the osmolarity of the contents.
• Should begin Spring/Summer 2011
More on Rectal Health and Behaviors:
UCLA U19 MDP Project 3
Goal:
To guide development of rectal
microbicide products by
providing data on anal sex, anal
health, and the acceptability of
carrier methods for rectal
microbicides.
Methods: U19 RHB
 From October 2006-June 2009, 879 men and women from the
UCLA IPCP U19 0606414 in Los Angeles at the AIDS Research
Alliance and UCLA CARE Clinic and Baltimore at Johns Hopkins
University completed computer-administered self interviews
about sexual and hygiene behavior and anorectal symptoms,
and were tested for rectal STIs including Gonorrhea and
Chlamydia, other STIs (HSV, HPV, Syphilis) and underwent high
resolution anoscopy.
 The sample recruited half men who practiced receptive anal
intercourse (RAI) in the past month and half women practicing
RAI in the past year - recruited from community and HIV
clinics, advertisements online and in newspapers.
More Methods
 Lube use questions were designed to measure the
context of the behavior
 Frequency of lube use in the past month
 Types of lubes in the past month
– Lube use at last RAI (commercial brand, oil, lotion, spit,
desensitizing, other none)
 Rectal swabs were collected and tested for Neisseria
gonorrhoeae (GC) and Chlamydia trachomatis (CT)
with the Aptima Combo 2 assay by PCR.
 Associations examined with rectal Chlamydia and
rectal Gonorrhea ) were assessed
Rectal Gonorrhea/Chlamydia
Prevalence
rGC/CT
rGC/CT among those
responding about lubricant use
frequency
N
24/776
17/344
%
3.1%
4.9%
•Significantly more women were infected in both compartments (44%
of those with rGC/CT also had cervical infection) whereas few men
with rectal rGC/CT also had urethral infection (6.7%).
Frequency of Commercial Lube Use*
in Past Month** (n=380)
Always
Sometimes or never
N
%
137
243
36%
64%
Frequency of Commercial Lube Use
at Last RAI (n=351)
N
%
224
64%
* “Commercial lubricants” were “those that you can buy in a store or on-line such as KY-jelly.” It was
specified that using saliva or the lubricant that comes with condoms were not considered “commercial
lubricant use”.
**Among those reporting RAI in the past month
Figure 1: Percent of Individuals with Rectal
STIs By Lubricant Use Frequency (n=344)
10
9
%
8
8.73
RGC/CT (n=17)*
rCT (n=13)*
rGC (n=6)
7.14
7
R
S
e
T
c
I
t
a
l
6
5
4
3
3.03
2.75
1.83
2
0.88
1
0
*P<0.05
Always Lubricant Use
Sometimes or never lubricant use
Logistic Regression of Predictors
Rectal CT/GC (n=325)
Univariate analysis Multivariable
odds ratio (95% CI) analysis
Adjusted odds
ratio
(95% CI)
0.94 (0.91- 0.98)
0.93 (0.87- 0.99)
1.72 (0.74- 3.98)
2.24 (0.67- 7.49)
1.21 (0.54- 2.74)
0.90 (0.31- 2.59)
0.77 (0.33-1.79)
1.32 (0.40- 4.37)
1.01 (0.98- 1.04)
0.98 (0.90- 1.08)
Age
Male
Los Angeles vs Baltimore
HIV positive
Number RAI partners in past
month
Number RAI acts in past month
0.98 (0.90- 1.07)
Always commercial lubricant use 3.38 (1.22- 9.37)
for RAI past month*
-3.28 (1.11- 9.67)
Commercial Lubricant Use Among those
Reporting Lube Use for RAI in Past Month
(n=301)*
Silicon-based (e.g., Eros® brand)
Water-based (e.g., brands like KY®, Wet®)
Oil-based (e.g., Crisco®)
Numbing**
Reported no lube types
Reported only 1 type
Reported 2 types
Reported 3 types
* Respondents checked ALL that they used in the past month so sum >100
**Lubricant that reduces feeling in your butt, vagina or penis
N
76
228
55
26
313
239
40
22
%
25.2%
75.7%
18.3%
8.6%
Of lube
users
50.9%
38.9% 79.4%
6.5% 13.3%
3.6% 7.3%
rSTIs by Type of Lubricant:
Water Based
• rGC/CT was significantly higher in lubricant users who
reported using water-based lubricants in the past month
compared to those did not use water based lubricants (6.2%
versus 1.34%; p=0.004 – 13/17 vs 4/17).
• This latter reflected those who used only water lubricants plus
those that used other types of lubricant users but may have
used more than one other type of lubricant.
• When those who used exclusively water-based lubricants
were compared to those who exclusively used either silicone
or oil-based lubricants, the trend remained but there was not
enough power to determine statistical significance : 7/9 vs
2/9.
rSTIs by Types of Lubricant:
non water Based
• Also those using silicone lubricants versus those not
using silicone lubricant (8.7% vs 2.35%, p=.014)
• There was no difference in those reporting only using
oil based lubricants and those who used other
lubricants.
• There were not enough cases of rSTI by type of
lubricant used to assess these differences in
multivariate analyses.
Numbers of Lubes Used: More not
merrier
• Those with rSTI reported greater numbers of lubricants used
than those without rSTI
• Mean of 1.01 lubricants reported by those who did not have
rSTI vs. 1.37 types of lubricants used in the past month by
those who were rSTI positive; t-test p-value=0.03).
• Males reported using significantly more lubricants than
females in the past month (mean 1.20 versus 0.75,
respectively p=.000)
Condoms?
• Condom use available for last 2 RAI events – not over past
month – different time period than lube use measured
• Much missing data – only 225 provided response
• Among those reporting condom use at last sex 34.4%
reported not using lubricant and 56.8% reported using
commercial lubricant use
• Among non-condom users fewer reported using lubricant at
last RAI than not using it (43.2% used lubricant versus 65.6%
who did not use lubricant, p-value=0.000).
• No significant difference in rSTIs between those reporting
condom use (4.4% of those reporting condom at last RAI had
rGC/CT vs 3.1% of those reporting not using a condom (p=.72
and n=5/8 vs 3/8).
• Not included in final model
Conclusions
• Always use of commercial lubricants during
receptive anal intercourse is associated with
prevalent rectal STI among men and women in
two US cities
• Need for more research on types of lubricant
products, their use during specific episodes of RAI,
tighter temporal relationships, frequency of use,
and potential mechanisms for how rectal lube use
may facilitate transmission of rectal STIs and HIV.
• Need to consider possible interaction with rectal
douching /enema use
Project 3 Team
UCLA
ARA
JHU
Peter Anton
Stephen Brown
Ed Fuchs
Robert Weiss
Marjan Hezareh
Yasmeen Long
Ross Cranston
Michelle Vertucci
Elizabeth Purdy
Alen Voskanian
Erica Yang
Craig Hendrix
Terry Saunders
Corigan Castro
John Hylton
Robin Jeffries
Colleen Murphy
Edward Robbie
Ava Lena Waldman
Ryan Murphy
Kristen Hess
Alex Carballo-Dieguez*
King Holmes*
*Consultant