Pregnancy Clinical Trial
Official title:
A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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