Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336245
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2006-06-11
Brief Title:
A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized trial of the intrauterine contraceptive device IUD versus users 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None