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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336245
• Other study ID #: EGPAF PG-51161
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2006
• Last updated: March 5, 2015
• Start date: June 2002
• Est. completion date: October 2005

Study information

• Verified date: August 2009
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection
• Pregnancy

Intervention

Device:
• Copper T Intrauterine Contraceptive Device

Drug:
• Hormonal Contraception

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Elizabeth Glaser Pediatric AIDS Foundation, United States Agency for International Development (USAID)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident pregnancy
Secondary	Safety
Secondary	Method discontinuation rates