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Comparison of Two IUDs Among Cape Town HIV-positive Women

Primary Purpose

HIV

Status

Completed

Phase

Not Applicable

Locations

South Africa

Study Type

Interventional

Intervention

Mirena levonorgestrel IUD

Copper T-380a IUD

About this trial

This is an interventional treatment trial for HIV focused on measuring 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 Council for 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

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

University of Cape Town

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Copper T-380a IUD

Mirena Levonorgestrel IUD

Arm Description

Copper T-380a IUD

Mirena levonorgestrel IUD

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

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).

Measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD.

Compare three genital tract sampling methods to determine which provides optimal recovery of HIV RNA and immune mediators over a series of three visits.

Full Information

NCT ID

NCT01721798

First Posted

October 18, 2012

Last Updated

August 17, 2018

Sponsor

FHI 360

Collaborators

University of Cape Town, City University of New York, School of Public Health

1. Study Identification

Unique Protocol Identification Number

NCT01721798

Brief Title

Comparison of Two IUDs Among Cape Town HIV-positive Women

Official Title

Comparison of Two IUDs Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

November 10, 2013 (Actual)

Primary Completion Date

July 13, 2018 (Actual)

Study Completion Date

July 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FHI 360

Collaborators

University of Cape Town, City University of New York, School of Public Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV

Keywords

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 Council for 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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

205 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Copper T-380a IUD

Arm Type

Active Comparator

Arm Description

Copper T-380a IUD

Arm Title

Mirena Levonorgestrel IUD

Arm Type

Active Comparator

Arm Description

Mirena levonorgestrel IUD

Intervention Type

Device

Intervention Name(s)

Mirena levonorgestrel IUD

Intervention Description

Intrauterine contraception system

Intervention Type

Device

Intervention Name(s)

Copper T-380a IUD

Intervention Description

intrauterine contraception system

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

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

Title

Measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD.

Time Frame

24 months

Title

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

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

B Landon Myer, MBChB, PhD

Organizational Affiliation

University of Cape Town

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Catherine Todd, MD, MPH

Organizational Affiliation

FHI 360

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cape Town

City

Cape Town

State/Province

Western Cape Province

ZIP/Postal Code

7701

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32611546

Citation

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.

Results Reference

derived

PubMed Identifier

32442189

Citation

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.

Results Reference

derived

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Comparison of Two IUDs Among Cape Town HIV-positive Women

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