Male Circumcision for HIV Prevention in Rakai, Uganda - Full Text View

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) John E. Fogarty International Center (FIC)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00425984

Purpose

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.

Condition	Intervention	Phase
HIV Infections Herpesvirus 2, Human Syphilis Genital Diseases, Male	Procedure: Adult male circumcision	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda

Resource links provided by NLM:

MedlinePlus related topics: AIDS Circumcision Reproductive Health Sexually Transmitted Diseases Syphilis

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

HIV acquisition
safety of circumcision

Secondary Outcome Measures:

Sexually transmitted infections
sexual risk behaviors
acceptability

Estimated Enrollment:	5000
Study Start Date:	August 2002
Estimated Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	15 Years to 49 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425984

Locations

Uganda, Rakai
Rakai Health Sciences Program, P.O. Box 279
Kalisizo Town, Rakai, Uganda

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

John E. Fogarty International Center (FIC)

Investigators

Principal Investigator:

Ronald H. Gray, MD

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

More Information

Publications:

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.

de Bruyn G, Smith MD, Gray GE, McIntyre JA, Wesson R, Passos GD, 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.

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.

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.

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. No abstract available.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

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.

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.

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. Epub 2007 Jun 1.

Study ID Numbers:	U1AI171-1-02, U1 AII 171-01-02, U1 AI 171-1-02
Study First Received:	January 23, 2007
Last Updated:	August 23, 2007
ClinicalTrials.gov Identifier:	NCT00425984 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV
Male circumcision
Sexually transmitted infections
Sexual risk behaviors
Adult males
Haemophilus ducreyi

Human papillomavirus
Rakai
Uganda
HIV seronegativity
HPV
STI

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Acquired Immunodeficiency Syndrome

Sexually Transmitted Diseases
Genital Diseases, Male
Retroviridae Infections
Syphilis
Immunologic Deficiency Syndromes
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Sexually Transmitted Diseases, Bacterial
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Genital Diseases, Male
Immunologic Deficiency Syndromes

Gram-Negative Bacterial Infections
Genital Diseases, Female
Virus Diseases
Treponemal Infections
Spirochaetales Infections
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Syphilis
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009