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 range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)