1. Update on Rectal Lubricant Use Research
Pamina M. Gorbach, UCLA

2. 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)

3. 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

4. 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 -

5. 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).

6. 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

7. 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.

8. 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.

9. 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.

10. 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.

11. AWARE Progress
Over 300 participants already completed lube questionnaire
Data should be complete in July 2011 

12. 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

13. New IRMA-UCLA web douching survey
Funded by UCLA AIDS Institute
In collaboration with IRMA, we will conduct an internet-survey 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.

14. 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

15. Douche Survey: Recruitment
We plan to use a similar recruitment strategy to IRMA lube survey that was brief 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.

16. 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.

17. 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

18. 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.

19. Methods: U19 RHB
From October 2006-June 2009, 879 men and women from the UCLA IPCP U 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.

20. 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

21. Rectal Gonorrhea/Chlamydia Prevalence%
rGC/CT
24/776
3.1%
rGC/CT among those responding about lubricant use frequency
17/344
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%).

22. Frequency of Commercial Lube Use* in Past Month** (n=380)%
Always
137
36%
Sometimes or never
243
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

23. Figure 1: Percent of Individuals with Rectal STIs By Lubricant Use Frequency (n=344)

24. Logistic Regression of Predictors Rectal CT/GC (n=325)
Univariate analysis
odds ratio (95% CI)
Multivariable analysis
Adjusted odds ratio
(95% CI)
Age
0.94 ( )
0.93 ( )
Male
1.72 ( )
2.24 ( )
Los Angeles vs Baltimore
1.21 ( )
0.90 ( )
HIV positive
0.77 ( )
1.32 ( )
Number RAI partners in past month
1.01 ( )
0.98 ( )
Number RAI acts in past month
0.98 ( ) --
Always commercial lubricant use for RAI past month*
3.38 ( )
3.28 ( )

25. Commercial Lubricant Use Among those Reporting Lube Use for RAI in Past Month (n=301)*%
Silicon-based (e.g., Eros® brand) 76
25.2%
Water-based (e.g., brands like KY®, Wet®)
228
75.7%
Oil-based (e.g., Crisco®) 55
18.3%
Numbing** 26
8.6%
Reported no lube types
313
50.9%
Of lube users
Reported only 1 type
239
38.9%
79.4%
Reported 2 types 40
6.5%
13.3%
Reported 3 types 22
3.6%
7.3%
* Respondents checked ALL that they used in the past month so sum >100
**Lubricant that reduces feeling in your butt, vagina or penis

26. 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.

27. 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.

28. 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 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)

29. 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

30. 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

31. Project 3 Team ARA JHU UCLA *Consultant Stephen Brown Marjan Hezareh
Michelle Vertucci
Erica Yang
Corigan Castro
Colleen Murphy
Ava Lena Waldman
Ed Fuchs
Yasmeen Long
Elizabeth Purdy
Craig Hendrix
John Hylton
Peter Anton
Robert Weiss
Ross Cranston
Alen Voskanian
Terry Saunders
Robin Jeffries
Edward Robbie
Ryan Murphy
Kristen Hess
Alex Carballo-Dieguez*
King Holmes*
*Consultant