Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women (NCT01721798) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women
South Africa199 participantsStarted 2013-11-10
Plain-language summary
This study will inform international medical guidelines as to whether the Levonorgestrel intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and acceptable, the introduction of this method to HIV positive women in developing countries could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion Criteria
* Willing and able to provide written informed consent (IC) to be screened for and to participate in the trial
* Interested and willing to use the intrauterine device (IUD) as a family planning method.
* Between 18 to 40 years of age (inclusive): This age range includes women during their years of greatest fertility and 18 is the age of majority for research consent in South Africa.
* Willing to participate in all aspects of the study and to comply with study procedures and visits, for 24 months, including:
* Be randomized
* Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)
* Provide contact/locator information
* Agree for site staff to review clinic chart to confirm HIV status
* Has documented HIV infection
* For pre-antiretroviral therapy (ART) entrants:
* ART-ineligible at screening, based on current South African ART guidelines
* Be at least 6 months post-delivery and not pregnant or desiring pregnancy for the next 30 months.
* For ART-using entrants:
* ART-use demonstrated by clinical records reflecting laboratory measures consistent with ART use and evidence of viral suppression (plasma viral load (VL)\<1000 copies/mL) at the most recent VL measure.
* Be at least 6 weeks post-delivery and not pregnant or desiring pregnancy for the next 30 months.
* Intending residence in Cape Town area for next 30 months
* No documented or known history of infertility or steriliz…
What they're measuring
1
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)