Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006324
Status:
COMPLETED
Last Update Posted:
2008-08-07
First Post:
2000-10-02
Brief Title:
Hormonal Birth Control and the Risk of Acquiring HIV
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Hormonal Contraception and the Risk of HIV Acquisition
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out whether hormonal birth control increases decreases or does not change the risk of women becoming infected with HIV
Sexual intercourse between men and women is the main way HIV is transmitted About 90 percent of HIV infections in women are caused by sexual intercourse Also hormonal birth controls are widely used This study hopes to find out whether hormonal birth control changes the risk of women becoming infected with HIV
Sexual intercourse between men and women is the main way HIV is transmitted About 90 percent of HIV infections in women are caused by sexual intercourse Also hormonal birth controls are widely used This study hopes to find out whether hormonal birth control changes the risk of women becoming infected with HIV
Detailed Description:
Heterosexual intercourse is the primary mode of HIV transmission worldwide and accounts for about 90 of HIV infections in women Hormonal contraceptives including COCs and injectables are among the most widely used contraceptives in the world Understanding the impact of hormonal contraception on HIV transmission is a critical unanswered public health question Because of the critical nature of this issue to women of reproductive age worldwide a methodologically sound study must be undertaken It must be determined if hormonal contraceptive use increases the risk of HIV infection and the magnitude of the association if it exists
This study takes place in Thailand Uganda and Zimbabwe HIV-seronegative women continue using their current birth control method low dose COC DMPA injections or non-hormonal contraceptive methods condoms sterilization or no modern contraception method for the duration of the study They are followed every 12 weeks for a minimum of 15 months and a maximum of 24 months or until seroconversion Pelvic exams including Pap smears are done blood samples are drawn and vaginal and cervical specimens are tested for any sexually transmitted diseases STDs Women are provided with free treatment for any STDs that are diagnosed They complete a questionnaire on sexual behavior and contraceptive history counseling on contraceptive use and reducing HIV risk is provided
This study takes place in Thailand Uganda and Zimbabwe HIV-seronegative women continue using their current birth control method low dose COC DMPA injections or non-hormonal contraceptive methods condoms sterilization or no modern contraception method for the duration of the study They are followed every 12 weeks for a minimum of 15 months and a maximum of 24 months or until seroconversion Pelvic exams including Pap smears are done blood samples are drawn and vaginal and cervical specimens are tested for any sexually transmitted diseases STDs Women are provided with free treatment for any STDs that are diagnosed They complete a questionnaire on sexual behavior and contraceptive history counseling on contraceptive use and reducing HIV risk is provided
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: