Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women

NCT ID: NCT01721798

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-10
• Study Completion Date: 2018-07-13

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 antiretroviral therapy (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 ribonucleic acid (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

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Copper T-380a Intrauterine Device (C-IUD)

Copper T-380A Intrauterine Device with approximately 380 mm2 exposed copper. Devices used were those included as part of the South African public sector health formulary.

Group Type: ACTIVE_COMPARATOR

Copper T-380a IUD

Intervention Type: DEVICE

intrauterine contraception system

Levonorgestrel IUD (LNG-IUD)

Levonorgestrel IUD containing 52 mg levonorgestrel registered for contraceptive use in South Africa at the time of the trial.

Group Type: ACTIVE_COMPARATOR

Mirena levonorgestrel IUD

Intervention Type: DEVICE

Intrauterine contraception system

Interventions

Mirena levonorgestrel IUD

Intrauterine contraception system

Intervention Type: DEVICE

Copper T-380a IUD

intrauterine contraception system

Intervention Type: DEVICE

Eligibility 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 intrauterine device (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-antiretroviral therapy (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 viral load (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 Principal Investigator (PI), would preclude provision of informed consent, make participation in the study unsafe, or complicate interpretation of data.

Exclusion Criteria

• Known congenital or acquired uterine anomaly including fibroids distorting the uterine cavity;
• Known acute liver disease or hepatic neoplasm;
• Known copper storage disease;
• Known hypersensitivity to any component of the levonorgestrel IUD (LNG IUD) or copper IUD (C-IUD) or latex allergy
• Pregnant or desiring pregnancy in next 24 months
• Gross cervical lesion concerning for neoplasia
• CD4 lymphocyte count<350 cells/mm3 if not using ART
• Less than 6 weeks postpartum

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cape Town

OTHER

Sponsor Role: collaborator

City University of New York, School of Public Health

OTHER

Sponsor Role: collaborator

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

B Landon Myer, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Catherine Todd, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Locations

University of Cape Town

Cape Town, Western Cape, South Africa

Countries

South Africa

References

Langwenya N, Todd CS, Jones HE, Hoover DR, Hu NC, Ronan A, Myer L. Risk-based screening to identify reproductive tract infection among HIV-infected women desiring use of intrauterine contraceptives. BMJ Sex Reprod Health. 2021 Apr;47(2):137-143. doi: 10.1136/bmjsrh-2019-200494. Epub 2020 Jul 1.

Reference Type: DERIVED

PMID: 32611546 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32442189 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

10369

Identifier Type: -

Identifier Source: org_study_id