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.

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Presentation transcript:

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

Background Kenya launched VMMC in >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

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

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

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

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)

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

Time to Complete Wound Healing

Time to Complete Healing Time HIV – negativeHIV – positive N not healed% healedN not healed% healed Baseline Week Week Week Week Week Week Week Week

Resumption of Sex Marital Status Sex before Healed YesNo Married1990 Unmarried11105 HIV StatusSex before Healed YesNo Positive1458 Negative16137 RR = % CI = (0.92 – 3.69) RR = % 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 (75.1)30 (13.3)

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)

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

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