Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 8:29 AM
Study NCT ID:
NCT01191203
Status:
COMPLETED
Last Update Posted:
2013-10-25
First Post:
2010-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007435', 'term': 'Intrauterine Devices, Copper'}, {'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}, {'id': 'C050795', 'term': 'N,N-dimethyl-4-anisidine'}], 'ancestors': [{'id': 'D007436', 'term': 'Intrauterine Devices, Medicated'}, {'id': 'D007434', 'term': 'Intrauterine Devices'}, {'id': 'D003274', 'term': 'Contraceptive Devices, Female'}, {'id': 'D003273', 'term': 'Contraceptive Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-23', 'studyFirstSubmitDate': '2010-06-02', 'studyFirstSubmitQcDate': '2010-08-27', 'lastUpdatePostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '1 year', 'description': 'Number of clients continuing with method at 1 year'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1 year', 'description': '-Number of clients who experience adverse events such as pelvic inflammatory disease, lower genital tract infection, and infection related complications, such as abdominal pain, and irregular vaginal bleeding, as well as lower tract infection determined by clinical examination.\n\nSide effects such as abnormal vaginal discharge, abnormal bleeding, IUCD expulsion, and other side effects, as measured by clinical examination and client self-report.\n\n-Risk of excessive vaginal bleeding or anemia: determined by self report and hemoglobin level'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acceptability and Adherence to methods'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The IUD is an extremely effective method of contraception yet few women use it worldwide. Considered safe to use in HIV+ women, few studies have evaluated its use among those using antiretroviral therapy. The only prior randomized trial looking at the IUD compared to hormonal contraception noted a high rate of IUD discontinuations. Understanding IUD acceptability and continuation is critical to improve utilization.\n\n* Objective 1: Determine WHO medical eligibility and the willingness for IUD placement\n* Objective 2: Compare method-related side effects and adverse events\n* Objective 3: Assess the 1-year acceptability and continuation rates\n\nMethods: To address our objectives the investigators have designed a two Phase Study:\n\n* A cross-sectional screening to evaluate contraceptive medical eligibility and desirability\n* A randomized controlled trial that will compare acceptability and adherence to DMPA compared to the Copper IUD: enrolling 200 women stable on antiretroviral therapy to follow for 1 year'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Can provide informed consent\n* Women ages 18-45\n* Known HIV + status on antiretroviral therapy for at least 6 months\n* Not currently pregnant\n* Willing to initiate either DMPA or CuT380A-IUD. Women currently using DMPA or CuT380A-IUD will be excluded\n* Do not desire to become pregnant within next 12 months\n* Intend to stay in Lilongwe region for the duration of the study\n* No known uterine anomalies based upon history\n* Greater than or equal to 4 weeks post partum\n* No known or suspected genital tract cancer\n* No evidence of current pelvic inflammatory disease or cervicitis. Women with cervicitis at the time of examination will be treated with antibiotics and eligibility will be reassessed at a follow-up visit at least 7 days after treatment\n* No pelvic inflammatory disease within prior 3 months\n* No contraindications to DMPA or the CuT380A-IUD per the WHO medical eligibility criteria or Malawi National Reproductive Health Service Delivery Guidelines, 2007\n* Based on clinical assessment, no condition that would preclude start of study intervention\n\nExclusion Criteria:\n\n* Women ages younger than18 or older than 45\n* Known HIV + status on antiretroviral therapy less than 6 months or not on antiretroviral therapy\n* Pregnant\n* Uterine anomaly\n* Less than 4 weeks post partum\n* Suspected genital tract cancer\n\nInclusion Criteria:\n\n•Current STI or PID'}, 'identificationModule': {'nctId': 'NCT01191203', 'briefTitle': 'Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Prospective Assessment of Acceptability and Adherence Associated With Use of the Copper Intrauterine Device (CuT380A-IUCD) Compared to Depo-medroxyprogesterone Acetate (DMPA) Among HIV Positive Women in Lilongwe, Malawi', 'orgStudyIdInfo': {'id': 'IRB00037535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Depo Medroxyprogesterone Acetate', 'interventionNames': ['Drug: Depo Medroxyprogesterone acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Copper IUD (CuT360)', 'interventionNames': ['Drug: Copper IUD']}], 'interventions': [{'name': 'Copper IUD', 'type': 'DRUG', 'description': 'Copper IUD (CuT360)', 'armGroupLabels': ['Copper IUD (CuT360)']}, {'name': 'Depo Medroxyprogesterone acetate', 'type': 'DRUG', 'otherNames': ['DMPA', 'Depo Provera'], 'description': 'DMPA 150 mg IM q 3 months', 'armGroupLabels': ['Depo Medroxyprogesterone Acetate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lilongwe', 'state': 'Lilongwe', 'country': 'Malawi', 'facility': 'The Lighthouse Trust', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}], 'overallOfficials': [{'name': 'Lisa Haddad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Sam Phiri, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lighthouse Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lisa Haddad', 'investigatorAffiliation': 'Emory University'}}}}