Male Circumcision for HIV Prevention in Rakai, Uganda
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda |
- HIV acquisition
- safety of circumcision
- Sexually transmitted infections
- sexual risk behaviors
- acceptability
| Estimated Enrollment: | 5000 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | December 2006 |
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 |
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| Uganda | |
| Rakai Health Sciences Program, P.O. Box 279 | |
| Kalisizo Town, Rakai, Uganda | |
| 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00425984 History of Changes |
| Other 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 |
| 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 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Genital Diseases, Male Syphilis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Treponemal Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Infection Genital Diseases, Female |
ClinicalTrials.gov processed this record on March 10, 2013
