N/A
N=199
Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01721798 ↗Enrolled (actual)
199
Serious AEs
19.6%
Results posted
Feb 2024
Primary outcome: Primary: Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL) — 18; 23; 10; 7 Participants — p=0.66
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mirena levonorgestrel IUD (Device); Copper T-380a IUD (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- FHI 360
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL) |
18; 23; 10; 7; 19; 18 | 0.66 |
| SECONDARY Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART) |
14; 12; 11; 20; 18; 19 | 0.64 |
| SECONDARY Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety |
12.4; 12.8; 12.4; 12.2; 12.6; 12.3 | — |
| SECONDARY Participants Continuing Use of the Allocated Intrauterine Device (IUD) |
36; 31; 65; 67; 36; 21 | <0.001 sig |
| SECONDARY HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method |
28; 18; 21; 26; 14; 21 | — |
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.
Eligibility Criteria
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 sterilization
- No gross evidence of cervical neoplasia on examination
- No prior history of ectopic pregnancy
- No history of or suspected hormonally-dependent neoplasm or undiagnosed abnormal vaginal bleeding
- Local language fluency and comprehension
- Not participating in any other clinical trial with a biomedical intervention
- Have no condition that, based on the opinion of the Site Principal Investigator (PI), would preclude provision of informed consent, make participation in the study unsafe, or complicate interpretation of data.
Exclusion Criteria
- Known congenital or acquired uterine anomaly including fibroids distorting the uterine cavity;
- Known acute liver disease or hepatic neoplasm;
- Known copper storage disease;
- Known hypersensitivity to any component of the levonorgestrel IUD (LNG IUD) or copper IUD (C-IUD) or latex allergy
- Pregnant or desiring pregnancy in next 24 months
- Gross cervical lesion concerning for neoplasia
- CD4 lymphocyte count<350 cells/mm3 if not using ART
- Less than 6 weeks postpartum
Data sourced from ClinicalTrials.gov (NCT01721798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.