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Comparison of Two IUDs Among Cape Town HIV-positive Women

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ClinicalTrials.gov Identifier: NCT01721798
Recruitment Status : Completed
First Posted : November 6, 2012
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
University of Cape Town
City University of New York, School of Public Health
Information provided by (Responsible Party):
FHI 360

Tracking Information
First Submitted Date  ICMJE October 18, 2012
First Posted Date  ICMJE November 6, 2012
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE November 10, 2013
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2012)
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 ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • 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 ]
  • 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 ]
  • Measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD. [ Time Frame: 24 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2012)
change in genital tract HIV shedding (measured through viral load) [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 2, 2012)
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 ]
 
Descriptive Information
Brief Title  ICMJE Comparison of Two IUDs Among Cape Town HIV-positive Women
Official Title  ICMJE Comparison of Two IUDs Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa
Brief 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.
Detailed Description

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

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

Study size: At least 166 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE
  • Device: Mirena levonorgestrel IUD
    Intrauterine contraception system
  • Device: Copper T-380a IUD
    intrauterine contraception system
Study Arms  ICMJE
  • 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
Publications * Todd CS, Jones HE, Langwenya N, Hoover DR, Chen PL, Petro G, Myer L. Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: A randomized controlled trial. PLoS Med. 2020 May 22;17(5):e1003110. doi: 10.1371/journal.pmed.1003110. eCollection 2020 May.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2018)
205
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2012)
324
Actual Study Completion Date  ICMJE July 13, 2018
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01721798
Other Study ID Numbers  ICMJE 10369
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party FHI 360
Study Sponsor  ICMJE FHI 360
Collaborators  ICMJE
  • University of Cape Town
  • City University of New York, School of Public Health
Investigators  ICMJE
Principal Investigator: B Landon Myer, MBChB, PhD University of Cape Town
Principal Investigator: Catherine Todd, MD, MPH FHI 360
PRS Account FHI 360
Verification Date August 2018

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