Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-02 @ 8:56 AM
Study NCT ID:
NCT03196492
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between lactobacillus-dominant microbiota and sexually transmitted infections (STI)', 'timeFrame': '6 months', 'description': 'The investigators will determine if there is an association between lactobacillus-dominant microbiota and STIs. The investigators will report the prevalence of each vaginal community state types (CST) and STIs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microbial Colonization']}, 'descriptionModule': {'briefSummary': 'The investigators are doing a study on the bacteria that normally live in the vagina and what effect, if any, Depo-Provera has on the bacteria.\n\nWomen 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or sexually transmitted disease (STD) check-up, or have a child and are planning to receive a Depo-Provera shot for contraception or have declined the use of hormonal contraception may join.', 'detailedDescription': 'The investigators are doing a study on the bacteria that normally live in the vagina and what effect, if any, Depo-Provera has on the bacteria.\n\nWomen 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or STD check-up, or have a child and are planning to receive a Depo-Provera shot for contraception or have declined the use of hormonal contraception may join.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy 13-24 Adolescent Girls and Young Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 13-24\n* Female sex\n* Seeking contraceptive/ STI services OR has had a child OR is legally married\n* Has had consensual vaginal sex\n* Two years have passed since menses started\n* HIV negative by self-report\n* Willing to refrain from using douches, washes, or other similar feminine hygiene products. (Tampons are allowed)\n* Planning to receive the Depo-Provera shot, -OR- Have regular menstrual cycles with at least 21 - 45 days between menses and plans to use no hormonal birth control.\n\nExclusion Criteria:\n\n* Any other immunodeficiency (e.g. organ transplant recipient)\n* Recently pregnant (within 4 weeks), currently pregnant, or planning to become pregnant within the next 12 months\n* Currently breastfeeding\n* Hysterectomy or a known genital tract anomaly\n* Amenorrhea (except if caused by contraceptive method like the implant)\n* Antibiotic or antifungal use within past 30 days'}, 'identificationModule': {'nctId': 'NCT03196492', 'acronym': 'AIMS', 'briefTitle': 'Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Effect of Injectable Contraceptives on Inflammation, Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women', 'orgStudyIdInfo': {'id': 'IRB00126504'}, 'secondaryIdInfos': [{'id': '1R01HD092013', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD092013', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'No hormone', 'description': 'Half of the cohort (n=40) will have opted to forgo hormonal contraception (HC).', 'interventionNames': ['Other: No intervention']}, {'label': 'Depo-provera', 'description': 'Half of the cohort (n=40) will have opted to initiate injectable depo-provera (DMPA).'}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['No hormone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jenell Coleman Fennell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Maryland, College Park', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}