1. Elijah Odoyo-June 1,3, John Rogers 2, Walter Jaoko 1,3, Robert C. Bailey 1, 2 1 Nyanza Reproductive Health Society 2 University of Illinois at Chicago 3 University of Nairobi Wound healing and resumption of sex following medical circumcision of adult males in Kisumu, Kenya

2. Background Kenya launched VMMC in 2008 - >350,000 MC done to date Resuming sex before complete wound healing may modify the relationship between circumcision and HIV WHO recommends six-weeks sexual abstinence following MC but variation in time to healing and its determinants are not fully understood Interim results of our study assessing time to wound healing and resumption of sex are presented here

3. Objectives 1.Assess time to complete wound healing in HIV+ and HIV- men 2.Assess compliance with post-circumcision abstinence recommendations 3.Identify factors associated with variation in wound healing 4.Assess wound keratinization and it’s relationship with visible healing 5.Determine effect of MC on CD4 count, plasma viral load, and viral shedding from incision site

4. The study is being conducted in Kisumu, Kenya among men voluntarily seeking medical male circumcision services at UNIM clinic within Lumumba Health Centre Study Site

6. Methods Interviews at baseline and 8 follow-up visits Visual inspection of wound for apposition of edges, presence of gaps or disruptions, and scar formation Scar monitored for color progression on graduated scale from 1 to 15 Photographs of wound taken weekly for assessment of wound status by independent, blinded observer Wk0 Wk1 Wk2 Wk3Wk4 Wk5

7. Study Population Characteristics HIV - Negative N = 156 HIV - Positive N = 75 Total N = 231 Age Median (IQR)25.5 (22.0 – 29.0) 29.0 (25.0 – 33.0) 27.0 (23.0 – 30.0) Education - n(%) None Primary Secondary Beyond Secondary 2 (1.3) 73 (47.8) 48 (30.8) 33 (21.1) 1 (1.3) 36 (48.6) 33 (44.6) 4 (5.4) 3 (1.3) 109 (47.3) 81 (35.2) 37 (16.1) Marital Status – n(%) Married /cohabitating Single 63 (40.4) 93 (59.6) 48 (64.0) 27 (36.0) 111 (48.0) 120 (52.0)

8. Primary Outcome Variables Wound healing  Assessed clinically on 5 level variable  Collapsed into dichotomous outcome for this analysis (wound healing complete vs. not complete) Time to sex  Assessed clinically using 2 questions asked at each follow up Have you had sexual intercourse with any person since circumcision? How long after circumcision did you first have sexual intercourse?  Early sex: sex after circumcision before day of observed complete healing

9. Time to Complete Wound Healing

10. Time to Complete Healing Time HIV – negativeHIV – positive N not healed% healedN not healed% healed Baseline1560.0750.0 Week 11550.0750.0 Week 21531.3724.0 Week 311724.55625.3 Week 44670.32961.3 Week 51888.41284.0 Week 6894.8593.3 Week 7397.4293.3 Week 12199.10100

11. Resumption of Sex Marital Status Sex before Healed YesNo Married1990 Unmarried11105 HIV StatusSex before Healed YesNo Positive1458 Negative16137 RR = 1.84 95% CI = (0.92 – 3.69) RR = 1.86 95% CI = (0.96 – 3.60) Weeks post-op Sex before visit n (%) Sex before healed n (%) N = 225 Week 10 (0.0) Week 22 (1.0)0 (0.0) Week 38 (3.5)2 (1.0) Week 418 (7.9)9 (4.0) Week 554 (23.6)22 (9.8) Week 693 (40.6)27 (12.0) Week 7127 (55.5)28 (12.4) Week 12172 (75.1)30 (13.3)

12. Interim Results Summary 156 HIV-negative and 75 HIV-positive included – target sample size of 215 HIV-negative and 115 HIV-positive Wound healing is similar in HIV-negative & HIV-positive – largest difference in healing rates occurred at 4-weeks post- op 13.3% of men resumed sex before complete wound healing Married men may be more likely to engage in early sex (RR 1.84, 95%CI 0.92 – 3.69)

13. Conclusions Based on this interim analysis, the WHO recommendations for six weeks of post-circumcision abstinence should be maintained Consistent with recently published data from our group, there is indication that married men may be more likely to engage in early sex – these men and their partners should be targeted for special counseling concerning abstinence and condom use

14. Acknowledgements Study participants UNIM Clinic study staff Nyanza Reproductive Health Society Male Circumcision Consortium Bill and Melinda Gates Foundation