Hormonal Birth Control and the Risk of Acquiring HIV
|ClinicalTrials.gov Identifier: NCT00006324|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 7, 2008
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.
|Condition or disease||Intervention/treatment|
|HIV Infections||Drug: Ethinyl estradiol/levonorgestrel Drug: Medroxyprogesterone acetate|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6360 participants|
|Official Title:||Hormonal Contraception and the Risk of HIV Acquisition|
|Study Start Date :||December 1999|
|Estimated Study Completion Date :||December 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006324
|United States, North Carolina|
|Research Triangle Park, North Carolina, United States, 27709|
|Study Chair:||Charles Morrison|
|Study Chair:||Barbra Richardson|
|Principal Investigator:||Sungwal Rugpao|
|Principal Investigator:||Roy Mugerwa|
|Principal Investigator:||Francis Mmiro|
|Principal Investigator:||Tsungai Chipato|