Male Circumcision for HIV Prevention in Rakai, Uganda

NCT00425984 | Completed Phase 3

• 3 other identifiers: U1AI171-1-02U1 AII 171-01-02U1 AI 171-1-02
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Circumcision in HIV unifected men may reduce the likelihood of becoming infected with HIV, reduce sexually transmitted infections (STIs) in men, not engender increases in sexual risk behaviors, and be acceptable to men as a procedure for preventing HIV. The purpose of this study is to evaluate circumcision in HIV uninfected men in terms of safety and ability to prevent HIV infection.

Conditions

HIV Infections; Herpesvirus 2, Human; Syphilis; Genital Diseases, Male

Keywords

HIV; Male circumcision; Sexually transmitted infections; Sexual risk behaviors; Adult males; Haemophilus ducreyi; Human papillomavirus; Rakai; Uganda; HIV seronegativity; HPV; STI

Outcome Measures

Primary Outcomes (2)

• HIV acquisition

• safety of circumcision

Secondary Outcomes (3)

• Sexually transmitted infections

• sexual risk behaviors

• acceptability

Interventions

Adult male circumcision PROCEDURE

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Rakai Health Sciences Program, P.O. Box 279

Kalisizo Town, Rakai, Uganda

Location

Related Publications (17)

• 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.

  PMID: 17254337 BACKGROUND

• 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.

  PMID: 11089626 BACKGROUND

• 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.

  PMID: 10199231 BACKGROUND

• 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.

  PMID: 16284475 BACKGROUND

• 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.

  PMID: 17321311 RESULT

• 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.

  PMID: 26094162 DERIVED

• 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.

  PMID: 22210632 DERIVED

• 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.

  PMID: 21216000 DERIVED

• 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.

  PMID: 20370483 DERIVED

• 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.

  PMID: 19936044 DERIVED

• 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.

  PMID: 19571722 DERIVED

• 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.

  PMID: 19389002 DERIVED

• 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.

  PMID: 19321868 DERIVED

• 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.

  PMID: 19220138 DERIVED

• 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.

  PMID: 18532873 DERIVED

• 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.

  PMID: 18086100 DERIVED

• 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.

  PMID: 17545184 DERIVED

MeSH Terms

Conditions

HIV Infections; Syphilis; Genital Diseases, Male; Sexually Transmitted Diseases; Chancroid

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Haemophilus Infections; Pasteurellaceae Infections

Study Officials

• Ronald H. Gray, MD

  Department of Population, Family and Reproductive Health Sciences, Bloomberg School of Public Health, Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 24, 2007
• Study Start: August 1, 2002
• Study Completion: December 1, 2006
• Last Updated: August 24, 2007

Record last verified: 2007-08

Locations

UG (1)