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Completed

NCT Number: NCT00425984

Male Circumcision for HIV Prevention in Rakai, Uganda

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.

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Key information

Conditions

HIV Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Chancroid Communicable Diseases Disease Attributes Genital Diseases Genital Diseases, Male Gram-Negative Bacterial Infections Haemophilus Infections Herpesvirus 2, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Male Urogenital Diseases Pasteurellaceae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases, Viral Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases Virus Diseases

Age range

15 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Rakai Health Sciences Program, P.O. Box 279

Kalisizo Town, Rakai, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adult male circumcision

Procedure

Primary outcomes

  1. HIV acquisition

  2. safety of circumcision

Secondary outcomes

  1. Sexually transmitted infections

  2. sexual risk behaviors

  3. acceptability

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Jan 24, 2007
Registry last updated
Aug 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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