Clinical trial NCT00425984: Male Circumcision for HIV Prevention in Rakai, Uganda
Official title: Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2007-01-24
Enrollment: 5000
Sex: MALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: HIV acquisition
measure: safety of circumcision
Secondary outcomes:
measure: Sexually transmitted infections
measure: sexual risk behaviors
measure: acceptability
Other outcomes:
Locations:
city: Kalisizo Town
country: Uganda
facility: Rakai Health Sciences Program, P.O. Box 279
state: Rakai
Study officials:
affiliation: Department of Population, Family and Reproductive Health Sciences, Bloomberg School of Public Health, Johns Hopkins University
name: Ronald H. Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/00002030-200010200-00019.
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