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A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia

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ClinicalTrials.gov Identifier: NCT00336245
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : March 6, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
A randomized trial of the intrauterine contraceptive device (IUD) versus user's choice hormonal contraception (injectable progestins or oral contraceptive pills) among HIV-infected, recently post-partum women in Lusaka, Zambia.

Condition or disease Intervention/treatment Phase
Pregnancy HIV Infection Device: Copper T Intrauterine Contraceptive Device Drug: Hormonal Contraception Phase 3

Detailed Description:

In the year 2000, there were over 37, 000 new acceptors of family planning in the Lusaka District Clinics. A variety of methods were prescribed, including combined oral contraceptive pills, injectable progestins, the intrauterine copper device, condoms, and others. The most recent sentinel survey of reproductive age women estimated that approximately 30% of reproductive age women in Lusaka are HIV-infected. Since voluntary HIV counseling and testing is not yet universally available in many of the district clinics, women receive all different types of contraception regardless of their HIV status.

There is some observational data published recently that suggests hormonal contraception may increase HIV viral load in the female genital tract and potentially increase HIV transmission to the male partner. By contrast, barrier methods have historically been very unpopular in stable couples and are not used consistently in many cases despite intensive counseling. The IUCD represents one of the most inexpensive and effective methods of birth control available in Lusaka. However, it has not been studied adequately to make policy recommendations regarding its use in HIV infected women. The purpose of this study will be to evaluate safety and acceptability of the IUCD versus hormonal methods of contraception in HIV-infected and uninfected women in Lusaka. Specifically, we will 1) compare the contraceptive effectiveness of the IUCD to the standard practices of user-chosen hormonal contraception, 2) compare the rates of pelvic infection between IUD and hormonal contraceptive users, and 3) compare rates of method discontinuation.

Patients who have a continuing second trimester pregnancy, serologically confirmed HIV infection, a desire for 24 months of contraception, and a willingness to be randomly assigned either an IUCD or hormonal contraception postpartum will be screened at 32 weeks in their pregnancies to receive either an IUCD or user chosen hormonal contraception postpartum. Women will then be seen at postpartum weeks 4-6 for method randomization and then at months 6, 12, 18 and 24 to monitor pregnancy, continuation of method, side effects and any other problems. Women will be encouraged to return for problems at any time. At least once yearly, women will have a complete physical exam. CD4 and HIV clinical status will be monitored regularly.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
Study Start Date : June 2002
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Copper T Intrauterine Contraceptive Device Device: Copper T Intrauterine Contraceptive Device
Active Comparator: Hormonal Contraception Drug: Hormonal Contraception

Outcome Measures

Primary Outcome Measures :
  1. Incident pregnancy

Secondary Outcome Measures :
  1. Safety
  2. Method discontinuation rates

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • desire for at least 2 years of continuous contraception
  • two or fewer sexual partners in the prior year

Exclusion Criteria:

  • advanced HIV disease (WHO Stage III or IV)
  • history of a bleeding disorder
  • history of PID within the prior five years
  • less than 16 years of age (the "age of majority" in Zambia).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336245

Sponsors and Collaborators
University of Alabama at Birmingham
Elizabeth Glaser Pediatric AIDS Foundation
United States Agency for International Development (USAID)
Principal Investigator: Jeffrey Stringer, MD University of Alabama at Birmingham
More Information

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00336245     History of Changes
Other Study ID Numbers: EGPAF PG-51161
First Posted: June 13, 2006    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: August 2009

Keywords provided by University of Alabama at Birmingham:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances