|
Male Circumcision and HIV Rates in Kenya Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Male Circumcision and HIV Rates in Kenya conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Male Circumcision and HIV Rates in Kenya Clinical research trials and Male Circumcision and HIV Rates in Kenya health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Male Circumcision and HIV Rates in Kenya. Male Circumcision and HIV Rates in Kenya Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Male Circumcision and HIV Rates in Kenya clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Male Circumcision and HIV Rates in Kenya condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Male Circumcision and HIV Rates in Kenya  Male Circumcision and HIV Rates in Kenya
Male Circumcision and HIV Rates in Kenya
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of HIV infections in young men.
Details: Since 1989, numerous epidemiological studies have reported a significant association between lack of male circumcision (MC) and risk for HIV infection through heterosexual intercourse. These results have led to calls for male circumcision to be considered as an additional HIV prevention strategy. However, there is a consensus among the international health community that a randomized controlled trial of MC is needed to control for possible confounding factors. Additionally, known risks associated with MC need further investigation. This study will assess the effectiveness of male circumcision in reducing HIV incidence and will evaluate complications of the MC procedure, changes in sexual behavior following circumcision, and the biological mechanisms by which the foreskin may increase HIV susceptibility. The study will be conducted in Kisumu, Kenya, where the Luo tribe is the main ethnic group and less than 10% of adult men are circumcised. Uncircumcised men aged 18 to 24 years old will be offered voluntary HIV counseling and testing. HIV negative men will be asked to enroll in the study. All study participants will be interviewed to obtain socio-demographic information and assess behavioral risk factors. Participants will be examined for significant medical conditions. All men will be counseled in strategies to reduce their risk for HIV infection. Consenting men will be randomly assigned to either the treatment (circumcised) arm or the control (uncircumcised) arm of the study. After circumcision, men will be monitored for complications. They will be counseled to abstain from sex until healing is complete. Follow-up visits will occur every 6 months for 2 years. Uncircumcised men will be offered circumcision at the end of follow-up. The primary study endpoints will be HIV incidence and surgical complications. Additional outcomes will be the incidence of other sexually transmitted diseases and behavioral risks. Additional laboratory studies of foreskin tissue will evaluate the number and density of specialized cells rich in HIV receptors in order to illuminate the biological mechanisms by which presence of foreskin may increase HIV susceptibility.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/24 Years
Genders: Male
Protocol Entry Criteria: Inclusion Criteria - HIV uninfected and willing to be tested - Live in Kisumu District, Kenya - Uncircumcised but willing to be circumcised - At least one sexual partner in the 12 months prior to study entry
Total Enrollment: 3000
Location and Contact Information:
Overall Study Official:
RobertBailey, Principal Investigator, University of Illinois
UNIM Clinic *Recruiting*
Kisumu, ,
Kenya
Recruiting Kwango Agot 0733-912603
Additional Information:
Study ID Numbers: 5U01AI050440-02;
Study Start Date: February 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059371
Other Hiv Infections Studies:
1. A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients
2. The Effects of Anti-HIV Drugs on the HIV Virus in HIV-Infected Patients
3. A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
4. Effect of a T-20 Based Anti-HIV Drug Regimen on HIV Reservoirs
5. Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other Kisumu Clinical Trials
Male Circumcision and HIV Rates in Kenya
|
|
|
|
|
|
|
|
