Comparison of Two IUDs Among Cape Town HIV-positive Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by FHI 360
Sponsor:
Collaborators:
University of Cape Town
The City University of New York
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01721798
First received: October 18, 2012
Last updated: May 19, 2014
Last verified: May 2014

October 18, 2012
May 19, 2014
November 2013
April 2017   (final data collection date for primary outcome measure)
change in plasma viral load and time to ART initiation between HIV-positive ART-naive women using the levonorgestrel IUD and those using the copper IUD over 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
change in plasma viral load and time to ART initiation between HIV-positive ART-naive women using the levonorgestrel IUD and those using the copper IUD over 24 months.
Same as current
Complete list of historical versions of study NCT01721798 on ClinicalTrials.gov Archive Site
change in genital tract HIV shedding (measured through viral load) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
IUD continuation rates between HIV-positive ART-naive women using the levonorgestrel IUD and those using the copper IUD over 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
 
Comparison of Two IUDs Among Cape Town HIV-positive Women
Comparison of Two IUDs Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
HIV
  • Device: Mirena levonorgestrel IUD
    Intrauterine contraception system
  • Device: Copper T-380a IUD
    intrauterine contraception system
  • Active Comparator: Copper T-380a IUD
    Copper T-380a IUD
    Intervention: Device: Copper T-380a IUD
  • Active Comparator: Mirena Levonorgestrel IUD
    Mirena levonorgestrel IUD
    Intervention: Device: Mirena levonorgestrel IUD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
324
April 2017
April 2017   (final data collection date for primary outcome measure)

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:

-

Female
18 Years to 40 Years
Yes
Contact: Catherine Todd, MD, MPH 01166849790115 ctodd@fhi360.org
South Africa
 
NCT01721798
10369
Yes
FHI 360
FHI 360
  • University of Cape Town
  • The City University of New York
Principal Investigator: B Landon Myer, MBChB, PhD University of Cape Town
FHI 360
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP