A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
Primary Purpose
Pregnancy, HIV Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Copper T Intrauterine Contraceptive Device
Hormonal Contraception
Sponsored by

About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Contraception, Women, HIV/AIDS, IUD, IUCD
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Copper T Intrauterine Contraceptive Device
Hormonal Contraception
Arm Description
Outcomes
Primary Outcome Measures
Incident pregnancy
Secondary Outcome Measures
Safety
Method discontinuation rates
Full Information
NCT ID
NCT00336245
First Posted
June 11, 2006
Last Updated
March 5, 2015
Sponsor
University of Alabama at Birmingham
Collaborators
Elizabeth Glaser Pediatric AIDS Foundation, United States Agency for International Development (USAID)
1. Study Identification
Unique Protocol Identification Number
NCT00336245
Brief Title
A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
Official Title
A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Elizabeth Glaser Pediatric AIDS Foundation, United States Agency for International Development (USAID)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, HIV Infection
Keywords
Contraception, Women, HIV/AIDS, IUD, IUCD
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Arm Title
Copper T Intrauterine Contraceptive Device
Arm Type
Experimental
Arm Title
Hormonal Contraception
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Copper T Intrauterine Contraceptive Device
Intervention Type
Drug
Intervention Name(s)
Hormonal Contraception
Primary Outcome Measure Information:
Title
Incident pregnancy
Secondary Outcome Measure Information:
Title
Safety
Title
Method discontinuation rates
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Stringer, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
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