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Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women

NCT01721798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2024-02-05

Study results available
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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.

Conditions

Interventions

DEVICE

Mirena levonorgestrel IUD

Intrauterine contraception system

DEVICE

Copper T-380a IUD

intrauterine contraception system

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • City University of New York, School of Public Health

    collaborator OTHER

  • FHI 360

    lead OTHER

Principal Investigators

  • B Landon Myer, MBChB, PhD · University of Cape Town

  • Catherine Todd, MD, MPH · FHI 360

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-10
Primary Completion
2018-07-13
Completion
2018-07-13

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01721798 on ClinicalTrials.gov