Hormonal Birth Control and the Risk of Acquiring HIV

August 6, 2008 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Hormonal Contraception and the Risk of HIV Acquisition

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

6360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Research Triangle Park, North Carolina, United States, 27709
        • Amy Lovvorn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria

Women may be eligible for this study if they:

  • Are 16 to 35 years of age.
  • Attend family planning and maternal and child health clinics in Zimbabwe, Thailand, or Uganda.
  • Have been using low-dose birth control pills, DMPA injections, or non-hormonal birth control (condoms, sterilization, or no modern birth control method) for at least 3 months and plan to continue using the same type of birth control for a year.
  • Are HIV-negative.
  • Are sexually active.
  • Are at least 4.5 months after delivery, if they have given birth.
  • Agree to all study procedures, including HIV testing every 3 months, follow-up clinic visits, and home visits if they fail to return for follow-up.
  • Have a home address where they can be reached for follow-up visits.

Exclusion Criteria

Women will not be eligible for this study if they:

  • Are pregnant or plan to try to become pregnant in the next year. Women who become pregnant after enrolling in the trial will not be discontinued.
  • Are not currently using low-dose birth control pills or DMPA for birth control but have used low-dose birth control pills within the last 3 months, or DMPA for birth control within the previous 6 months.
  • Are HIV-indeterminate or HIV-positive.
  • Have used an IUD for birth control in the last month.
  • Have used non-study types of birth control (such as Norplant, NET-EN, or progestin-only pills) within the last 3 months.
  • Have had a full hysterectomy.
  • Have had an abortion or miscarriage within the last month.
  • Have had a blood transfusion within the last 3 months.
  • Were previously or are currently in an HIV vaccine trial.
  • Injected illegal drugs within the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Charles Morrison
  • Study Chair: Barbra Richardson
  • Principal Investigator: Sungwal Rugpao
  • Principal Investigator: Francis Mmiro
  • Principal Investigator: Tsungai Chipato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

October 2, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

August 7, 2008

Last Update Submitted That Met QC Criteria

August 6, 2008

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIVNET 021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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