Improving Data Quality in Rectal Studies: Measures

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Transcript Improving Data Quality in Rectal Studies: Measures

Rectal Behaviors: a global overview

Shauna Stahlman & Pamina M. Gorbach UCLA Department of Epidemiology

Introduction: Rectal Microbicides & Anal Behaviors  Anal hygiene and sexual behaviors are part of the behavioral repertoire for rectal microbicide use – Lubricant use – Rectal douching – Other  Different types of data needed and broader populations need studying (women, hetero men as well as MSM, cross-cultural data essential)

Peri-sexual Rectal practices – Lubricant Use

Background: Lubricants

 US data shows very high use: ex: 89% reported always using lubricant among US MSM in San Francisco (Carballo-Dieguez A et al 2007)  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  Some data suggest concerns with certain types of lubricant products

Lubricant Use & Non-Use:

IRMA/UCLA Internet Survey  59% of 6,124 men and women reporting AI reported always using commercial lubricant in large internet survey

Figure 2-6: Reasons for not Using Lubricant among Web Survey Respondents Reporting AI within the past 6 months (N = 1,746)

60 50 40 30 20 10 0

56,9 47,7 27,5 24,9 19,1 17,0 15,1 7,7 7,6 6,9 2,5

Javanbakht J et al 2010 – IRMA & UCLA internet survey

3 City Peruvian Study of Lubricant Use

Kinsler JJ,

Galea JT

, Peinado J, Segura P, Montano SM, Sánchez J. Lubricant use among men who have sex with men reporting receptive anal intercourse in Peru: implications for rectal microbicides as an HIV prevention strategy.

Aug;21(8):567-72.

Int J STD AIDS. 2010

Many Commercial Lubricants Available:

Project AWARE Lube Survey For recent US survey we found over 188 products available 1 Astroglide Liquid 2 Astroglide Gel 3 Astroglide Strawberry 4 5 Astroglide Glycerin & Paraben FREE Astroglide Natural 6 Astroglide X Silicone Lubricant 11 Wet Light 12 Wet Platinum 13 Wet Warming 14 Wet Oil Based 15 Wet Pheromone 16 Wet Naturals 21 Wet Comfort Kiwi Strawberry 22 Wet Comfort Sensitive Skin 23 Wet Flavored Blueberry 24 Wet Flavored Cherry 25 Wet Flavored Kiwi Strawberry 26 Wet Flavored Passion Fruit 31 Wet Fun Flavors Seductive Strawberry 32 Wet Synergy 33 Wet Synergy Cool Tingle 34 Wet Together 35 Pjur Bodyglide Original 36 Pjur Bodyglide Light 41 Pjur Superhero 42 Pjur AnalyseME 43 Pjur Backdoor 44 KY Jelly 45 46 KY Warming Jelly KY Tingling Jelly

Percent of Individuals with Rectal STIs By Lubricant Use Frequency (n=272

): RHB Study LA & Baltimore (n=896) *P<0.05

Gorbach PM, Weiss RE, Fuchs E, Jeffries R, Hezerah M, Brown S, Voskanian A, Robbie R, Anton P, Cranston RD. The Slippery Slope: Lubricant Use and Rectal Sexually Transmitted Infections: A Newly Identified Risk Sex Trans Dis, 39(1): 59-64, January 2012. PMCID: PMC3244680

Peri-sexual behaviors: Rectal Douching

Douching

 The prevalence estimates of douching before RAI from range from 19% - 64%  There is substantial evidence of associations between vaginal douching STIs  Rectal douching has been associated with HIV, HCV, HBV, non-LGV

C. trachomatis,

and LGV proctitis  No studies have considered the effect of rectal douching/enema use and lubricant use together

Anorectal Hygiene Behaviors:

RHB Study LA & Baltimore (n=896) Men % Women % Ever used an rectal douche/enema (n=426) Douche/ Enema use past 6 months among those who hv RAI Frequency past month 76 42 73 43 Mean (SD) 39 5.7

4.0(5.9)

Percent with Rectal GC/CT/Sy* By Douching Practice (n=614): RHB Study LA & Baltimore (n=896) **Among those douching in past month *n=27 cases of rectal STIs or active syphilis P=0.02

Sexual risk behaviors & STI history by douching status: IRMA/UCLA global web survey respondents (N=708) 6 5 5 *chi-square test, p<.01

2 4 3

Median #

2 1 0 Sex partners** **Wilcoxon rank-sum test, p<.01

Characteristics associated with rectal douching*:

IRMA/UCLA global web-survey respondents (N=708)

Characteristic

Age Number of sexual partners Lube use Illicit drug use Being HIV positive Reported STI

Adjusted Odds Ratio

1.06

1.02

5.67

2.00

2.30

1.43

95% Confidence Interval

(1.03, 1.08)* (1.00, 1.04)* (2.31, 13.95)* (1.29, 3.11)* (1.33, 3.96)* (0.77, 2.68) *p<0.05

Other Rectal Behaviors

Other Rectal Behaviors:

RHB Study LA & Baltimore (n=896) Ever used suppository > 1 colonic past year Object in butt past month Rimmed past month Fisted past month Anal bleaching past year “Booty-bumped” -drugs in butt with last partner

Male % (n)

38.4(101/263) 15.8 (64/405) 21 (48/229) 35.8 (82/229) 6.7 (15/225) 0 7

Female % (n)

40.3 (85/211) 13.7 (55/402) 10.6 (16/151) 16.7 (25/151) 5.3 (8/151) 1 1

Rectal Sexual Behaviors

Anal Intercourse: Lifetime (ever)

NSFG US General Population Chandra A, Mosher WD et al. Sexual Behavior, Sexual Attraction, and Sexual Identity in the United States: Data From the 2006–2008 National Survey of Family Growth. National Health Statistics Reports n Number 36 n March 3, 2011

AI Past Year: National Survey of Sexual Health and Behavior ‘10 Journal of Sexual Medicine - http://www.nationalsexstudy.indiana.edu/

Low Frequency of AI: NSSHB 2010 (n=5,885)    0 women reported AI > 4x per week < 6% reported AI “a few times per month to weekly” or “2-3 times per week” combined > ¼ of married & partnered women 18-24 years reported AI “about once a month to a few times a year”    < 5% of men report insertive AI > monthly Most report “not in past year” Highest percent of those reporting any in past year report “few times per year to monthly”

Details from Women on AI :

RHB Study LA & Baltimore (n=896)  62 % had RAI past month (53/85)  At last AI, 89.3% also had vaginal sex (167/187) – – 39.1% (70/179) used a condom for vaginal sex 66.5% (115/173) ejaculated during this  For last AI 41.4% used a condom (77/186) – 44.4% had ejaculate inside (79/178)  74% of last RAI partners were main partners

Sexual Acts at Most Recent Sexual Event:

MSM US Internet Survey (n-24,787) Most commonly reported sexual behaviors:    Giving oral sex (75.0%, N = 18,590) Kissing their sexual partner on the mouth (74.8%, N = 18,541) Receiving oral sex (73.4%, N = 18,194)    Receptive anal intercourse 35.5% Insertive anal intercourse 33.8% most common among men ages 18 –24 (42.7%)  42.3% of all men reported most recent male sexual partner was with a relationship partner.

Rosenberger J et al 2011

Sexual Behavior: Non US – Focus on AI

International: Women Reporting Ever AI

Brazil

: Silveira MF , 2002; Caetano ME , 2010

Peru:

Caceres C et al. 1997

China (Anhui) :

Lui H et al 1998

South Africa

– Lane, Pettior et al 2006

Kenya:

Schwandt M et al. 2006

Nigeria:

Bamidele et al 2009 (combined gender)

Condom Use for AI: Women

South Africa

: Kalichman et al 2009

Kenya – FSW-

Schwandt M et al. 2006

US Gen Pop US-MDP – –

Indiana NSSHB- 2010 Gorbach, unpublished

VOICE – South Africa, Uganda, Zimbabwe –

2011 – baseline

unpublished

Discussion

 Worldwide, many have reported ever having AI – but in US data suggest frequency is not high among women  Condom use levels for AI in non-Western studies appear to range greatly but more data is needed  The sexual repertoire around AI is broad - often includes other activities such as oral sex or VI – but this is based on research in Western countries  Not possible to make assumptions about behavioral repertoire around AI in non-Western settings

Discussion – Rectal Behaviors

 Data on rectal behaviors is growing but is still limited outside of Western countries – especially for African countries  Non-Western data on rectal behaviors come from small, non-generalizable studies  New data on rectal behaviors should be coming soon from microbicide clinical trials and Project ARM – IRMA’s rectal microbicide advocacy effort in Africa…..stay tuned!