HIVNCT01721798
Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women
A study testing Mirena levonorgestrel IUD and Copper T-380a IUD in people with HIV, run by FHI 360 at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Mirena levonorgestrel IUD and Copper T-380a IUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteSouth Africa
- Study dates
- 10 Nov 2013to 13 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 23Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Intrauterine Devices (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.
Read the 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
- Being tested
- Mirena levonorgestrel IUD, Copper T-380a IUD
- 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
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirena levonorgestrel IUDDevice
Intrauterine contraception system
Copper T-380a IUDDevice
intrauterine contraception system
| Study group | Role | What they receive |
|---|---|---|
| Copper T-380a Intrauterine Device (C-IUD) | Active comparator | 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. Receives: Device: Copper T-380a IUD |
| Levonorgestrel IUD (LNG-IUD) | Active comparator | Levonorgestrel IUD containing 52 mg levonorgestrel registered for contraceptive use in South Africa at the time of the trial. Receives: Device: Mirena levonorgestrel IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
Number of women with detectable genital tract HIV RNA as measured with menstrual cup sampling at each scheduled visit. Level of detection was 20-40 copies/mL depending on assay; outcome was dichotomous with copies above level of detection coded as detectable and those below level of detection considered undetectable.
Measured: Enrollment to 24 months
Secondary outcomes (4)
Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)
The proportion of women using ART at enrollment with detectable plasma HIV RNA viral load. Viral load assays detected HIV RNA levels at 20-40 copies/mL as the lower limit of detection. The outcome measure coded values above that limit as detectable and those below as undetectable for women using ART and in mean viral load for women not using ART.
Measured: Enrollment to 24 months
Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety
Participant hemoglobin measured at baseline, 6, 12, 18, and 24 months with blood sample with mean hemoglobin calculated and trends over time assessed. Other safety measures were included with this secondary outcome, such as adverse events, summarized with descriptive statistics.
Measured: Enrollment to 24 months
Participants Continuing Use of the Allocated Intrauterine Device (IUD)
Measure of the number of women continuing to use the allocated intrauterine device (IUD) across all visits as a measure of acceptability. Proportion of women using the allocated IUD measured at each scheduled visit with time using the IUD adjusted for discontinuation at unscheduled visits. Continuation rate analyzed longitudinally with Kaplan-Meier survival analysis.
Measured: Enrollment to 24 months
HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method
Proportion of specimens with quantifiable genital viral load compared by specific sampling method (menstrual cup, endocervical swab, and swab-enriched lavage) at enrollment, 3 months and 6 months among women not using antiretroviral therapy (ART). Allocated intrauterine device (IUD) was not considered in this analysis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study start10 Nov 2013
- Primary completion13 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, City University of New York, School of Public Health
- Responsible party
- Sponsor
- Investigators
- B Landon Myer, MBChB, PhD, Principal investigator, University of Cape TownCatherine Todd, MD, MPH, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721798
- Sponsor's protocol ID
- 10369
- Status last verified
- May 2023
- First submitted
- 18 Oct 2012
- Last updated
- 5 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Happel AU, Passmore JS, Sinkala M, Jaumdally SZ, Gamieldien H, Hu NC, Langwenya N, Jones HE, Hoover DR, Myer L, Todd CS. Genital Inflammatory Responses in Women Living with HIV Randomized to Copper or Levonorgestrel Intrauterine Contraceptives: A secondary analysis of a randomized trial. medRxiv [Preprint]. 2026 May 26:2026.05.24.26353969. doi: 10.64898/2026.05.24.26353969.
PubMed 42245049Langwenya 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.
PubMed 32611546Todd 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.
PubMed 32442189
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa
- ClinicalTrials.gov ID
- NCT01721798
- Acronym / sponsor ID
- 10369
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- University of Cape Town, City University of New York, School of Public Health
- Study start
- 10 Nov 2013 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Posted 5 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copper T-380a Intrauterine Device (C-IUD) | Active comparator | Device: Copper T-380a IUDCopper 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. |
| Levonorgestrel IUD (LNG-IUD) | Active comparator | Device: Mirena levonorgestrel IUDLevonorgestrel IUD containing 52 mg levonorgestrel registered for contraceptive use in South Africa at the time of the trial. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- 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:
- Has documented HIV infection
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirena levonorgestrel IUDIntrauterine contraception system | Device | Levonorgestrel IUD (LNG-IUD) |
| Copper T-380a IUDintrauterine contraception system | Device | Copper T-380a Intrauterine Device (C-IUD) |
Primary outcome
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
Time frame: Enrollment to 24 months
Number of women with detectable genital tract HIV RNA as measured with menstrual cup sampling at each scheduled visit. Level of detection was 20-40 copies/mL depending on assay; outcome was dichotomous with copies above level of detection coded as detectable and those below level of detection considered undetectable.
4 secondary outcomes
Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)
Time frame: Enrollment to 24 months
Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety
Time frame: Enrollment to 24 months
Participants Continuing Use of the Allocated Intrauterine Device (IUD)
Time frame: Enrollment to 24 months
HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42245049Happel AU, Passmore JS, Sinkala M, Jaumdally SZ, Gamieldien H, Hu NC, Langwenya N, Jones HE, Hoover DR, Myer L, Todd CS. Genital Inflammatory Responses in Women Living with HIV Randomized to Copper or Levonorgestrel Intrauterine Contraceptives: A secondary analysis of a randomized trial. medRxiv [Preprint]. 2026 May 26:2026.05.24.26353969. doi: 10.64898/2026.05.24.26353969.
- Derived from this study: PubMed 32611546Langwenya 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.
- Derived from this study: PubMed 32442189Todd 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B Landon Myer, MBChB, PhD principal investigator
University of Cape Town
Catherine Todd, MD, MPH principal investigator
FHI 360
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirena levonorgestrel IUD and Copper T-380a IUD in people with HIV, run by FHI 360 at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL) (time frame: Enrollment to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721798, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.