Measuring Anal Intercourse in Vaginal Microbicide Studies/Trials Pamina M. Gorbach Associate Professor, Epidemiology and Infectious Diseases UCLA Measuring Anal Intercourse in Vaginal Microbicide Studies/Trials

Data Sources for AI Data collected in large US surveys – type and quality Data collected in microbicide related studies: U19 Data collected in past and future microbicide trials of women – comparisons of timeframes

NSFG -2002

Percent reporting anal sex intercourse ever and with last partner, by 3 US cities Gorbach PM Manhart LE, Hess KL, Stoner BP, Martin DH, Holmes KK. Anal Intercourse among Young Heterosexuals in Three US STD Clinics. Sex Transm Dis, 2009 April, 36(4):193-198. PMID: 19265740.

Multivariate logistic regression analyses, stratified by city, of having anal intercourse with most recent partner by gender: associated characteristics and behaviors. Gorbach PM Manhart LE, Hess KL, Stoner BP, Martin DH, Holmes KK. Anal Intercourse among Young Heterosexuals in Three US STD Clinics. Sex Transm Dis, 2009 April, 36(4):193-198. PMID: 19265740.

Reported type of sexual contact (past 90 days) among women attending public STD clinics, Los Angeles County, May 2006 – December 2007 Marjan Javanbakht: -amfAR Strategy and Synthesis Meeting 03.14.09 – and In Press, STD

Factors Associated with AI among WSM* *Multivariate model adjusted for age, race, substance use, and variable listed above Marjan Javanbakht: -amfAR Strategy and Synthesis Meeting 03.14.09 – and In Press, STD amfAR Strategy and Synthesis Meeting 03.14.09

Frequency of AI Among US Women: UCLA U19 Rectal Health and Behaviors 431 women total, 200 reporting “RAI+ in the past year” as eligibility criteria 53 (26%) reported having RAI in the past month –of those who reported RAI in past year Out of those 53 RAI in past month: 43/49 (87.8%) used a condom – collapsed over last 2 RAI acts 41/51(81%) used lube sometimes or always in the past month during AI 8/50 (16%) used a rectal douche – collapsed over last 2 RAI acts   There is no significant differences in age between the women who have had RAI in the past 30 days and those that have not. T=-.042,  p=.67 There is no association between race and having RAI in the past 30d, F=.01, p=.89

Data not Perfect: NHANES Males - “In the past 12 months, with how many males have you had anal or oral sex? and “With how many of these males have you had only oral sex? ” “In the past 12 months, about how many times have you had vaginal or anal sex?” “In the past 12 months, about how often have you had vaginal or anal sex without using a condom?

NHBS 38. Have you ever had oral or anal sex with a man? 39. How old were you the first time you had oral or anal sex with a man? 40. In the past 12 months, with how many different men have you had oral or anal sex?

Los Angeles County: STD Clinics amfAR Strategy and Synthesis Meeting 03.14.09

Questions on Anal Intercourse in Past Microbicide Trials: Non-MTN Carraguard Phase I Screening Interview 26. In the last month, did you have anal sex? 26a. If yes, about how many acts of anal sex did you have in the last month? 26b. Of those, how many times did your partner use a male condom? 26c. In the last month, how many times did a condom break or slip off when you were having anal sex? 29. Do you think any of the following is a risk factor for HIV? Please give your reason for each. Anal sex? explain Carraguard Phase I Acceptability Assessment 11. About how many times did you have anal sex since you were enrolled in the study?* Carraguard Phase III Screening Interview 10. In the past 3 months, have you had unprotected anal sex? Carraguard Phase III Behavioral Interview (Baseline) 14. Have you had unprotected anal sex since your last visit? Carraguard Phase III Exit 19. In general, how often did you use male condoms during anal sex?

Questions on Anal Intercourse in Past Microbicide Trials: Non-MTN IPM 003 Phase I/II Screening and Baseline Volunteer Questionnaire and IPM 005b Phase I/II Screening and Baseline Participant Questionnaire 15. During the past two weeks, did you have anal intercourse? (Note: Anal intercourse is “penetrative anal sex that may or may not end with ejaculation”) Yes, No, Not applicable IPM 003 Phase I/II During Study Volunteer Questionnaire & IPM 005b Phase I/II During Study Participant Questionnaire 30. During the past two weeks, did you have anal intercourse? (Note: Anal intercourse is “penetrative anal sex that may or may not end with ejaculation”) Cellulose Sulfate Phase III Screening 23. Have you had anal sex (penis in anus) or oral sex (penis in mouth) in the past 30 days? Cellulose Sulfate Phase III Enrollment Form 14. In the past 7 days, how many anal sex acts: with primary partner and with other partners? 15. In the past 7 days, how many anal sex acts using a new condom: with primary partner and with other partners? Cellulose Sulfate Phase III Follow-up Visit 19. In the past 7 days, how many anal sex acts using a new condom: with primary partner and with other partners?

MTN Trials – 035 and 059 HPTN 035 Phase II Behavioral Assessment (Enrollment Questionnaire) *5. Have you ever had anal sex? *6. In the past week, did you have anal sex? *6a. I know that you are counseled to use condoms for each act of anal sex, but I also know that this is not always possible. In the past week, did you ever, even once, have anal sex without a condom? *7. When was the last time you had anal sex? *8a. The last time you had anal sex: did you or your partner use a male condom? 8c. The last time you had anal sex: did you receive money, gifts, material goods, drugs, or shelter for this anal sex? HPTN 035 Phase II Follow-up Questionnaire 5. In the past 3 months, did you have anal sex? 6. In the past week, did you have anal sex? 6a. In the past week, did you ever, even once, have anal sex without a condom? 7. When was the last time you had anal sex? 8a. The last time you had anal sex: did you or your partner use a male condom? HPTN 059 Phase II Follow-up Behavior Assessment – Coitally Dependent Arm 6. In the past month, did you have anal sex? 7. In the past week, did you have anal sex? 7b. In the past week, did you ever, even once, have anal sex without a condom? 8. When was the last time you had anal sex? 9a. The last time you had anal sex: did you or your partner use a male condom? *HPTN 059 Phase II Screening and Daily Use Arm

MTN Study Data: Forthcoming in VOICE 003 Baseline and Follow-up 11. In the past 3 months how many times have you had anal sex? By anal sex we mean when a man puts his penis inside your anus.   11a. During the last act of anal sex that you had, was a male condom used? 11b. In the past 3 months, did you ever insert study gel into your anus?  11c. When was the last time you did this?

Timeframes for AI Data from Vaginal Microbicide Trials Last Anal Sex Last Week (7 days) Past 2 weeks Past Month (30 days) Past 3 months (90 days) Since last visit Ever AI Carraguard x X* IPM Cellulose Sulfate 004 (Vivagel) 059 035 003

MTN Studies – some contextual MTN 004 Phase I Baseline Behavioral Questionnaire 11. How old were you the first time you had anal sex because you wanted to? 22. Now I’d like to ask you about receptive anal sex. Remember, by receptive anal sex, I mean when a man or boy puts his penis inside your anus or butt. During the past 90 days, did you have receptive anal sex with any partners? Yes, No 25. Still thinking about the past 90 days, I want to ask you some questions about all of the male partners that you had sex with, either vaginal or anal, during that period. First, during the past 90 days did you ever ask a partner to use a condom? Yes, No 35. How many times did you have sex, either vaginal or anal, with this most recent main partner during the last 90 days? Please read the following list of sexual behaviors and indicate how much you would like doing each behavior with MEN if it were not for AIDS. Please answer each question regardless of whether you have ever done it or plan to do it in the future. 95. Having anal intercourse WITHOUT a condom Dislike very much; Dislike somewhat; Dislike slightly; Like slightly; Like somewhat; Like very much 96. Having anal intercourse WITH a condom 97. Having your partner ejaculate inside your rectum WITHOUT a condom 98. How much do condoms interfere with your sexual satisfaction when you are penetrated anally? 1—2—3—4—5—6—7—8—9—10 Not at all A lot

Conclusions While many women report ever/lifetime AI, fewer women report recent AI Those that do report recent AI – also report other risks for HIV – suggesting compounded risk Care needs to be taken in how questions are asked – wording, timeframes, and mode of interviewing (ie ACASI) Vaginal microbicide trials ARE collecting data on AI – but comparing across trials may be problematic due to different timeframes being used Great data on AI from women in vaginal microbicide trials forthcoming! Stay tuned…