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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
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Contraception, Women, HIV/AIDS, IUD, IUCD

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    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)
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    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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