Comparison of 2 IUDnCT Devices

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.

Design: Single site, double-blind, randomized controlled trial

Population: Antiretroviral therapy ineligible, HIV-positive South African women between the ages of 18 and 40 years

Study size: 324 women

Study intervention: Levonorgestrel intrauterine device (LNG IUD) or the copper T-380 intrauterine device (C-IUD)

Duration & Follow-up: Approximately 42 months in total. Recruitment will take approximately 18 months. After enrollment, each participant will be followed for 24 months.

Primary Objectives: To compare LNG IUD safety to the safety of the C-IUD by comparing HIV progression between the two study arms.

Secondary Objectives: 1) To measure LNG IUD safety with respect to genital viral load shedding, a surrogate for HIV infectivity, as compared to the C-IUD. 2) To measure LNG IUD acceptability through device continuation and other measures as compared to the C-IUD.

Primary Endpoints: HIV-1 Viral Load (VL) change, CD4 change, hemoglobin change, time to antiretroviral therapy (ART) initiation, incidence of sexually-transmitted infections (STIs) and pelvic inflammatory disease (PID)

Secondary Endpoints: 1) Initiation/acceleration of detectable HIV RNA genital shedding 2) IUD continuation and expulsion rates and acceptability measures through quantitative and qualitative methods

Study Site: Gugulethu Community Health Centre (GCHC), Cape Town, South Africa

• Active Comparator: 2
  Copper IUD
  Intervention: Device: Mirena levonorgestrel IUD and copper T-380a IUD
• Active Comparator: 1
  Levonorgestrel IUD
  Intervention: Device: Mirena levonorgestrel IUD and copper T-380a IUD

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 IUD as a family planning method.
  • Women between 18 to 40 years (inclusive).

  • 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
  • Have documented HIV infection.
  • Have a CD4 count >500 cells/mm3 in last 3 months.
  • Be at least 6 months post-pregnancy 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.
  • Atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), or normal cervical cytology within the last 36 months.
  • No history of or suspected hormonally-dependent neoplasm or undiagnosed abnormal vaginal bleeding.
  • Local language fluency and comprehension.
  • No history of adverse reaction to latex
  • Not participating in any other clinical trial with a biomedical intervention
  • Have no condition that, based on the opinion of the Site PI, would preclude provision of informed consent, make participation in the study unsafe or complicate interpretation of data.

Exclusion Criteria:

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• University of Cape Town
• The City University of New York