Comparison of Two IUDs Among Cape Town HIV-positive Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by FHI 360
Sponsor:
Collaborators:
University of Cape Town
City University of New York, School of Public Health
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01721798
First received: October 18, 2012
Last updated: January 8, 2016
Last verified: January 2016

October 18, 2012
January 8, 2016
November 2013
April 2018   (final data collection date for primary outcome measure)
Compare LNG IUD safety to the safety of the C-IUD with respect to genital HIV shedding, a surrogate for potential for HIV transmission, overall and in the presence and absence of ART. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01721798 on ClinicalTrials.gov Archive Site
  • Compare LNG IUD safety to the safety of the C-IUD with respect to HIV progression as measured by changes in plasma viral load (VL) at 6 months between the two pre-ART study arms. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Explore LNG IUD safety with respect to non-HIV related outcomes, including hemoglobin change, incidence of sexually-transmitted infections (STIs) and pelvic inflammatory disease (PID). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Compare three genital tract sampling methods to determine which provides optimal recovery of HIV RNA and immune mediators over a series of three visits. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change in genital tract HIV shedding (measured through viral load) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
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 ]
 
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: HIV-positive South African women between the ages of 18 and 40 years

Study size: 288 women

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

Duration & Follow-up: Approximately 48 months in total. Recruitment will take approximately 24 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 with respect to genital HIV shedding, a surrogate for potential for HIV transmission, overall and in the presence and absence of ART.

Secondary Objectives: 1) To compare LNG IUD safety to the safety of the C-IUD with respect to HIV progression as measured by changes in plasma viral load (VL) at 6 months between the two pre-ART study arms. 2) To explore LNG IUD safety with respect to non-HIV related outcomes, including hemoglobin change, incidence of sexually-transmitted infections (STIs) and pelvic inflammatory disease (PID). 3) To measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD. 4) To compare three genital tract sampling methods to determine which provides optimal recovery of HIV RNA and immune mediators over a series of three visits.

Primary Endpoints: Change in detection and quantity of HIV RNA genital VL measures between study arms at baseline and 6 months, and over 24 months following IUD insertion.

Secondary Endpoints: 1) Measures of HIV disease progression, including CD4 change, time to ART initiation, and mean plasma VL change from baseline to 6 and through 24 months among pre-ART women. 2) Hemoglobin change and incidence of STIs and PID for all participants through 24 months. 3) IUD continuation and expulsion rates between study arms comparing different IUDs over a 24-month period and acceptability measures through quantitative and qualitative methods. 4) Comparison of female genital tract sampling methods for recovery of HIV RNA as measured by VL and immune mediators (e.g. cytokines).

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
288
April 2018
April 2018   (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.
  • 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-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 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 PI, would preclude provision of informed consent, make participation in the study unsafe, or complicate interpretation of data.
Female
18 Years to 40 Years
Yes
Contact: Catherine Todd, MD, MPH 1-919-544-7040 ctodd@fhi360.org
South Africa
 
NCT01721798
10369
Yes
Not Provided
Not Provided
FHI 360
FHI 360
  • University of Cape Town
  • City University of New York, School of Public Health
Principal Investigator: B Landon Myer, MBChB, PhD University of Cape Town
Principal Investigator: Catherine Todd, MD, MPH FHI 360
FHI 360
January 2016

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