- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00425984
Male Circumcision for HIV Prevention in Rakai, Uganda
Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda
Study Overview
Status
Intervention / Treatment
Detailed Description
South Africa has one of the most severe and fast-growing HIV epidemics in the world. Adult male circumcision may be an effective preventive measure to slow the spread of HIV and other STIs. This study will assess the efficacy of circumcision in HIV uninfected men in preventing HIV and STI acquisition.
This study will have two stages. In the first stage, 200 men will be enrolled into a study of the acceptability, feasibility, and safety of circumcision. Frequent postoperative follow-up will occur to determine rates of healing and complications. After assessment of those enrolled in Stage 1, Stage 2 enrollment will begin. Stage 2 will determine the efficacy of circumcision in preventing HIV acquisition. In both stages, HIV uninfected men will be randomly assigned to have either immediate circumcision or possible circumcision 2 years following Stage 2 study entry. The participants not receiving immediate circumcision will be offered circumcision after completion of 2 years of follow-up study, provided there is evidence of the efficacy of this procedure at that time. If efficacy is still unknown after 2 years of follow-up, participants will be given the option of circumcision at the completion of the trial.
Postoperative follow-up visits will be scheduled between 24 to 48 hours, 5 to 9 days, and 4 to 6 weeks. At each postoperative visit, participants will be questioned about symptoms suggestive of complications, and the area operated on will be inspected. Participants will be asked about resumption of sexual intercourse, and those who have resumed sexual intercourse will be asked about condom use. Study visits will be also conducted regarding risk behaviors and symptoms of STIs, and these will occur sometime between Weeks 4 to 6, and at Months 6, 12, and 24 post-enrollment. At each study visit, assessment of circumcision status and penile pathology; blood, urine, and penile swabs collection; and HIV testing will occur, and counseling and health education will be provided.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Rakai
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Kalisizo Town, Rakai, Uganda
- Rakai Health Sciences Program, P.O. Box 279
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV uninfected
- Willing to receive HIV results
- Willing to be circumcised
- Parent or guardian willing to provide informed consent if applicable
- Hemoglobin of 8 grams/dl or less
- Intend to stay in Rakai, Uganda, for at least 1 year and are available for follow-up for 1 year
Exclusion Criteria:
- Already circumcised or partially circumcised
- Anatomical abnormality of the penis (e.g., hypospadias, severe phimosis) that may put the participant at risk if circumcised
- Medical conditions that require therapeutic circumcision
- Medical condition that contraindicates surgery or use of local anesthesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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HIV acquisition
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safety of circumcision
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Secondary Outcome Measures
Outcome Measure |
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acceptability
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Sexually transmitted infections
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sexual risk behaviors
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Collaborators and Investigators
Investigators
- Principal Investigator: Ronald H. Gray, MD, Department of Population, Family and Reproductive Health Sciences, Bloomberg School of Public Health, Johns Hopkins University
Publications and helpful links
General Publications
- Mehta SD, Gray RH, Auvert B, Moses S, Kigozi G, Taljaard D, Puren A, Agot K, Serwadda D, Parker CB, Wawer MJ, Bailey RC. Does sex in the early period after circumcision increase HIV-seroconversion risk? Pooled analysis of adult male circumcision clinical trials. AIDS. 2009 Jul 31;23(12):1557-64. doi: 10.1097/QAD.0b013e32832afe95.
- Wawer MJ, Tobian AA, Kigozi G, Kong X, Gravitt PE, Serwadda D, Nalugoda F, Makumbi F, Ssempiija V, Sewankambo N, Watya S, Eaton KP, Oliver AE, Chen MZ, Reynolds SJ, Quinn TC, Gray RH. Effect of circumcision of HIV-negative men on transmission of human papillomavirus to HIV-negative women: a randomised trial in Rakai, Uganda. Lancet. 2011 Jan 15;377(9761):209-18. doi: 10.1016/S0140-6736(10)61967-8. Epub 2011 Jan 6.
- Gray RH, Serwadda D, Tobian AA, Chen MZ, Makumbi F, Suntoke T, Kigozi G, Nalugoda F, Iga B, Quinn TC, Moulton LH, Laeyendecker O, Reynolds SJ, Kong X, Wawer MJ. Effects of genital ulcer disease and herpes simplex virus type 2 on the efficacy of male circumcision for HIV prevention: Analyses from the Rakai trials. PLoS Med. 2009 Nov;6(11):e1000187. doi: 10.1371/journal.pmed.1000187. Epub 2009 Nov 24.
- Kiggundu V, Watya S, Kigozi G, Serwadda D, Nalugoda F, Buwembo D, Settuba A, Anyokorit M, Nkale J, Kighoma N, Ssempijja V, Wawer M, Gray RH. The number of procedures required to achieve optimal competency with male circumcision: findings from a randomized trial in Rakai, Uganda. BJU Int. 2009 Aug;104(4):529-32. doi: 10.1111/j.1464-410X.2009.08420.x. Epub 2009 Apr 21.
- Tobian AA, Serwadda D, Quinn TC, Kigozi G, Gravitt PE, Laeyendecker O, Charvat B, Ssempijja V, Riedesel M, Oliver AE, Nowak RG, Moulton LH, Chen MZ, Reynolds SJ, Wawer MJ, Gray RH. Male circumcision for the prevention of HSV-2 and HPV infections and syphilis. N Engl J Med. 2009 Mar 26;360(13):1298-309. doi: 10.1056/NEJMoa0802556.
- Tobian AA, Charvat B, Ssempijja V, Kigozi G, Serwadda D, Makumbi F, Iga B, Laeyendecker O, Riedesel M, Oliver A, Chen MZ, Reynolds SJ, Wawer MJ, Gray RH, Quinn TC. Factors associated with the prevalence and incidence of herpes simplex virus type 2 infection among men in Rakai, Uganda. J Infect Dis. 2009 Apr 1;199(7):945-9. doi: 10.1086/597074.
- Kigozi G, Gray RH, Wawer MJ, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Ridzon R, Opendi P, Sempijja V, Settuba A, Buwembo D, Kiggundu V, Anyokorit M, Nkale J, Kighoma N, Charvat B. The safety of adult male circumcision in HIV-infected and uninfected men in Rakai, Uganda. PLoS Med. 2008 Jun 3;5(6):e116. doi: 10.1371/journal.pmed.0050116.
- de Bruyn G, Smith MD, Gray GE, McIntyre JA, Wesson R, Dos Passos G, Martinson NA. Circumcision for prevention against HIV: marked seasonal variation in demand and potential public sector readiness in Soweto, South Africa. Implement Sci. 2007 Jan 25;2:2. doi: 10.1186/1748-5908-2-2.
- Gray RH, Kiwanuka N, Quinn TC, Sewankambo NK, Serwadda D, Mangen FW, Lutalo T, Nalugoda F, Kelly R, Meehan M, Chen MZ, Li C, Wawer MJ. Male circumcision and HIV acquisition and transmission: cohort studies in Rakai, Uganda. Rakai Project Team. AIDS. 2000 Oct 20;14(15):2371-81. doi: 10.1097/00002030-200010200-00019.
- Kelly R, Kiwanuka N, Wawer MJ, Serwadda D, Sewankambo NK, Wabwire-Mangen F, Li C, Konde-Lule JK, Lutalo T, Makumbi F, Gray RH. Age of male circumcision and risk of prevalent HIV infection in rural Uganda. AIDS. 1999 Feb 25;13(3):399-405. doi: 10.1097/00002030-199902250-00013.
- Wawer MJ, Reynolds SJ, Serwadda D, Kigozi G, Kiwanuka N, Gray RH. Might male circumcision be more protective against HIV in the highly exposed? An immunological hypothesis. AIDS. 2005 Dec 2;19(18):2181-2. doi: 10.1097/01.aids.0000194132.51006.4f. No abstract available.
- Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
- Grabowski MK, Gray RH, Makumbi F, Kagaayi J, Redd AD, Kigozi G, Reynolds SJ, Nalugoda F, Lutalo T, Wawer MJ, Serwadda D, Quinn TC, Tobian AAR. Use of injectable hormonal contraception and women's risk of herpes simplex virus type 2 acquisition: a prospective study of couples in Rakai, Uganda. Lancet Glob Health. 2015 Aug;3(8):e478-e486. doi: 10.1016/S2214-109X(15)00086-8. Epub 2015 Jun 17.
- Gray R, Kigozi G, Kong X, Ssempiija V, Makumbi F, Wattya S, Serwadda D, Nalugoda F, Sewenkambo NK, Wawer MJ. The effectiveness of male circumcision for HIV prevention and effects on risk behaviors in a posttrial follow-up study. AIDS. 2012 Mar 13;26(5):609-15. doi: 10.1097/QAD.0b013e3283504a3f.
- Gray RH, Serwadda D, Kong X, Makumbi F, Kigozi G, Gravitt PE, Watya S, Nalugoda F, Ssempijja V, Tobian AA, Kiwanuka N, Moulton LH, Sewankambo NK, Reynolds SJ, Quinn TC, Iga B, Laeyendecker O, Oliver AE, Wawer MJ. Male circumcision decreases acquisition and increases clearance of high-risk human papillomavirus in HIV-negative men: a randomized trial in Rakai, Uganda. J Infect Dis. 2010 May 15;201(10):1455-62. doi: 10.1086/652184.
- Kigozi G, Watya S, Polis CB, Buwembo D, Kiggundu V, Wawer MJ, Serwadda D, Nalugoda F, Kiwanuka N, Bacon MC, Ssempijja V, Makumbi F, Gray RH. The effect of male circumcision on sexual satisfaction and function, results from a randomized trial of male circumcision for human immunodeficiency virus prevention, Rakai, Uganda. BJU Int. 2008 Jan;101(1):65-70. doi: 10.1111/j.1464-410X.2007.07369.x.
- Gray RH, Makumbi F, Serwadda D, Lutalo T, Nalugoda F, Opendi P, Kigozi G, Reynolds SJ, Sewankambo NK, Wawer MJ. Limitations of rapid HIV-1 tests during screening for trials in Uganda: diagnostic test accuracy study. BMJ. 2007 Jul 28;335(7612):188. doi: 10.1136/bmj.39210.582801.BE. Epub 2007 Jun 1.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1AI171-1-02
- U1 AII 171-01-02
- U1 AI 171-1-02
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