HIV InfectionsNCT00006324
Hormonal Birth Control and the Risk of Acquiring HIV
A study testing Ethinyl estradiol/levonorgestrel and Medroxyprogesterone acetate in people with HIV Infections, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ethinyl estradiol/levonorgestrel and Medroxyprogesterone acetate
- How many people
- 6,360 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Dec 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Amy Lovvorn
Research Triangle Park, North Carolina, 27709
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Ethinyl estradiol/levonorgestrel, Medroxyprogesterone acetate
- Keywords
- HIV Seronegativity, Delayed-Action Preparations, Risk Factors, Prevalence, Contraceptive Agents, Female, Contraceptives, Oral, Combined, Medroxyprogesterone 17-Acetate
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinyl estradiol/levonorgestrelDrug
Medroxyprogesterone acetateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startDec 1999
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 6,360 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Charles Morrison, Study chairBarbra Richardson, Study chairSungwal Rugpao, Principal investigatorRoy Mugerwa, Principal investigatorFrancis Mmiro, Principal investigatorTsungai Chipato, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006324
- Sponsor's protocol ID
- HIVNET 021
- Status last verified
- Nov 2006
- First submitted
- 2 Oct 2000
- Last updated
- 7 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Contraception and the Risk of HIV Acquisition
- ClinicalTrials.gov ID
- NCT00006324
- Acronym / sponsor ID
- HIVNET 021
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, Delayed-Action Preparations, Risk Factors, Prevalence, Contraceptive Agents, Female, Contraceptives, Oral, Combined, Medroxyprogesterone 17-Acetate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,360 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 1999
- Study completion
- Dec 2002
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethinyl estradiol/levonorgestrel | Drug | – |
| Medroxyprogesterone acetate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Morrison study chair
Barbra Richardson study chair
Sungwal Rugpao principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethinyl estradiol/levonorgestrel and Medroxyprogesterone acetate in people with HIV Infections, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2008.