Comparison of Two IUDs Among Cape Town HIV-positive Women

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
HIV	Device: Mirena levonorgestrel IUD; Device: Copper T-380a IUD	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	205 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Comparison of Two IUDs Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa
Actual Study Start Date :	November 2013
Estimated Primary Completion Date :	April 2018
Estimated Study Completion Date :	April 2018

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Copper T-380a IUD; Copper T-380a IUD	Device: Copper T-380a IUD; intrauterine contraception system
Active Comparator: Mirena Levonorgestrel IUD; Mirena levonorgestrel IUD	Device: Mirena levonorgestrel IUD; Intrauterine contraception system

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. Measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD. [ Time Frame: 24 months ]
4. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

South Africa
University of Cape Town
Cape Town, Western Cape Province, South Africa, 7701

Sponsors and Collaborators

FHI 360

University of Cape Town

City University of New York, School of Public Health

Investigators

Principal Investigator:	B Landon Myer, MBChB, PhD	University of Cape Town
Principal Investigator:	Catherine Todd, MD, MPH	FHI 360

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	FHI 360
ClinicalTrials.gov Identifier:	NCT01721798 History of Changes
Other Study ID Numbers:	10369
First Posted:	November 6, 2012
Last Update Posted:	February 12, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by FHI 360:

AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonization	IND Investigational New Drug Application; IRB Institutional Review Board; IU International units; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot

Additional relevant MeSH terms:

Levonorgestrel; Copper; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs	Contraceptives, Oral, Synthetic; Contraceptives, Oral; Trace Elements; Micronutrients; Growth Substances