Male Circumcision for HIV Prevention in Rakai, Uganda

HIV Infections Clinical Trial

Official title:

Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425984
• Other study ID #: U1AI171-1-02
• Secondary ID: U1 AII 171-01-02
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2007
• Last updated: August 23, 2007
• Start date: August 2002
• Est. completion date: December 2006

Study information

• Verified date: August 2007
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Adult male circumcision

Locations

Country	Name	City	State
Uganda	Rakai Health Sciences Program, P.O. Box 279	Kalisizo Town	Rakai

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	John E. Fogarty International Center (FIC)

Country where clinical trial is conducted

Uganda, 

References & Publications (5)

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. — View Citation

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 prev — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV acquisition
Primary	safety of circumcision
Secondary	Sexually transmitted infections
Secondary	sexual risk behaviors
Secondary	acceptability