- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01721798
Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women
Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Western Cape Province
-
Cape Town, Western Cape Province, South Africa, 7701
- University of Cape Town
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
intrauterine contraception system
|
Active Comparator: Levonorgestrel IUD (LNG-IUD)
Levonorgestrel IUD containing 52 mg levonorgestrel registered for contraceptive use in South Africa at the time of the trial.
|
Intrauterine contraception system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Enrollment to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)
Time Frame: Enrollment to 24 months
|
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.
|
Enrollment to 24 months
|
Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety
Time Frame: Enrollment to 24 months
|
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.
|
Enrollment to 24 months
|
Participants Continuing Use of the Allocated Intrauterine Device (IUD)
Time Frame: Enrollment to 24 months
|
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.
|
Enrollment to 24 months
|
HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: B Landon Myer, MBChB, PhD, University of Cape Town
- Principal Investigator: Catherine Todd, MD, MPH, FHI 360
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
- 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
- ICH International Council for Harmonization
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Urogenital Diseases
- Genital Diseases
- HIV Seropositivity
- Physiological Effects of Drugs
- Trace Elements
- Micronutrients
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Copper
- Levonorgestrel
Other Study ID Numbers
- 10369
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
CDC FoundationGilead SciencesUnknownHIV Preexposure Prophylaxis | HIV ChemoprophylaxisUnited States
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... and other collaboratorsRecruiting
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Fenway Community Health; Tuberculosis...CompletedHIV/STI Risk | HIV/STI IncidenceUnited States, India
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
University of WashingtonNational Institute of Mental Health (NIMH)RecruitingHIV Prevention | HIV Preexposure Prophylaxis | ImplementationKenya
-
University of Maryland, BaltimoreWithdrawnHiv | Kidney Transplant | HIV Reservoir | CCR5United States
Clinical Trials on Copper T-380a IUD
-
Albert Einstein College of MedicineCompletedIntrauterine Device ExpulsionUnited States
-
NYU Langone HealthIcahn School of Medicine at Mount SinaiCompletedContraception BehaviorUnited States
-
sara AbdAllahBeni-Suef UniversityUnknown
-
Boston UniversityUniversity of UtahCompletedMedical Abortion | Induced Abortion | Intrauterine Device ExpulsionUnited States
-
Taghreed AlhaidariElweyia Maternity Teaching HospitalCompletedContraception BehaviorIraq
-
Columbia UniversityCompletedImmediate Versus Delayed Insertion of the Copper Intrauterine Device (IUD) After Medication AbortionContraceptionUnited States
-
Zeynep Kamil Maternity and Pediatric Research and...CompletedIntrauterine Systems | Postpartum Immediate ContraceptionTurkey
-
University of Sao Paulo General HospitalEdson Santos Ferreira-Filho; Nilson Roberto de Melo; Isabel Cristina Esposito... and other collaboratorsRecruiting
-
University of UtahCompleted