Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT03490058
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Prevention Options for Women Evaluation Research (POWER) Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Dried blood spots'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2255}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-03-29', 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assess cost and cost-effectiveness of PrEP when delivered in public health clinics.', 'timeFrame': 'Up to 36 months', 'description': 'Time-motion studies will be conducted to define the cost and cost effectiveness of the intervention in terms of HIV infections averted, disability-adjusted life years saved, and incremental cost-effectiveness of PrEP over routine HIV care.'}, {'measure': 'Evaluate the acceptability of delivering expedited partner therapy.', 'timeFrame': 'Up to 36 months', 'description': 'Measure the number of women who accept STI expedited partner therapy and HIV self-test kits for their partners.'}, {'measure': 'Assess the effect of a decision support tool on PrEP uptake', 'timeFrame': 'Up to 36 months', 'description': 'Using a randomized design, evaluate if a decision support tool increases PrEP uptake.'}, {'measure': 'Evaluate the impact of HIV self-testing on PrEP delivery among young women receiving PrEP', 'timeFrame': 'Up to 12 months', 'description': 'Using a pretest posttest design, evaluate the feasibility of integrating HIV self-testing into PrEP delivery.'}], 'primaryOutcomes': [{'measure': 'Demonstrate PrEP delivery models for young women in different settings and geographies.', 'timeFrame': 'Up to 36 months', 'description': 'Mixed methods assessment of how PrEP is implemented at the user, provider, health care facility, and community levels.'}], 'secondaryOutcomes': [{'measure': 'PrEP initiation', 'timeFrame': 'Up to 36 months', 'description': 'Measure the number of young women who initiate PrEP.'}, {'measure': 'PrEP adherence', 'timeFrame': 'Up to 36 months', 'description': 'Adherence by young women to PrEP. Adherence will be measured by the timing of PrEP refills and self-reported PrEP use. Blood samples for detection and quantification of PrEP levels (testing in batch) will be done for those who seroconvert to HIV and a subset who remain HIV uninfected.'}, {'measure': 'HIV seroconversion', 'timeFrame': 'Up to 36 months', 'description': 'Assess HIV incidence during PrEP use and non-use.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-exposure prophylaxis', 'young women', 'delivery of health care', 'HIV infections/prevention'], 'conditions': ['HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '36170124', 'type': 'DERIVED', 'citation': "Katz AWK, Roberts S, Rousseau E, Khoza MN, Mogaka F, Bukusi E, Delany-Moretlwe S, Bekker LG, Morton JF, Johnson R, Baeten JM, Celum C, van der Straten A. Qualitative Analysis Using Social Maps to Explore Young Women's Experiences With Social Support of their Oral PrEP Use in Kenya and South Africa. J Assoc Nurses AIDS Care. 2023 Jan-Feb 01;34(1):45-57. doi: 10.1097/JNC.0000000000000363. Epub 2022 Sep 23."}, {'pmid': '35822945', 'type': 'DERIVED', 'citation': "Celum CL, Bukusi EA, Bekker LG, Delany-Moretlwe S, Kidoguchi L, Omollo V, Rousseau E, Travill D, Morton JF, Mogaka F, O'Malley G, Barnabee G, van der Straten A, Donnell D, Parikh UM, Kudrick L, Anderson PL, Haberer JE, Wu L, Heffron R, Johnson R, Morrison S, Baeten JM; POWER Study Team. PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project. J Int AIDS Soc. 2022 Jul;25(7):e25962. doi: 10.1002/jia2.25962."}, {'pmid': '35354456', 'type': 'DERIVED', 'citation': "Roche SD, Barnabee G, Omollo V, Mogaka F, Odoyo J, Bukusi EA, Morton JF, Johnson R, Celum C, Baeten JM, O'Malley G. Implementation strategies for integrating pre-exposure prophylaxis for HIV prevention and family planning services for adolescent girls and young women in Kenya: a qualitative study. BMC Health Serv Res. 2022 Mar 30;22(1):422. doi: 10.1186/s12913-022-07742-8."}, {'pmid': '33859147', 'type': 'DERIVED', 'citation': 'Omollo V, Bukusi EA, Kidoguchi L, Mogaka F, Odoyo JB, Celum C, Morton J, Johnson R, Baeten JM. A Pilot Evaluation of Expedited Partner Treatment and Partner Human Immunodeficiency Virus Self-Testing Among Adolescent Girls and Young Women Diagnosed With Chlamydia trachomatis and Neisseria gonorrhoeae in Kisumu, Kenya. Sex Transm Dis. 2021 Oct 1;48(10):766-772. doi: 10.1097/OLQ.0000000000001430.'}]}, 'descriptionModule': {'briefSummary': 'The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.', 'detailedDescription': 'PrEP will be delivered to young women according to emerging national guidelines in family planning clinics (Kisumu, Kenya), youth friendly clinics (Johannesburg, South Africa), and mobile youth friendly clinics (Cape Town, South Africa). The investigators will evaluate PrEP delivery and follow cohorts of young women at each clinic location to understand PrEP uptake and use. In the Kisumu clinics, the investigators will also offer expedited partner therapy and partner HIV self-tests to women who test positive for chlamydia and/or gonorrhea. At one clinic in Johannesburg, the investigators will evaluate the use of a decision support tool to improve the decision to initiate PrEP.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sexually active HIV uninfected women ages 16-25 will be recruited from family planning clinics, youth clinics, and youth outreach programs.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 16-25 (16 and 17 year olds, where permissible by national regulations and local IRB approval)\n* Able and willing to provide written informed consent\n* Recently sexually active (defined as having had vaginal intercourse at least once in the previous three months)\n* HIV uninfected based on negative HIV rapid tests, on the date of enrollment'}, 'identificationModule': {'nctId': 'NCT03490058', 'briefTitle': 'The Prevention Options for Women Evaluation Research (POWER) Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort', 'orgStudyIdInfo': {'id': 'STUDY00000950'}, 'secondaryIdInfos': [{'id': 'R01MH114544', 'link': 'https://reporter.nih.gov/quickSearch/R01MH114544', 'type': 'NIH'}, {'id': 'AID-OAA-A-15-00034', 'type': 'OTHER_GRANT', 'domain': 'US Agency for International Development'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young women', 'description': 'Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada.', 'interventionNames': ['Drug: Truvada']}], 'interventions': [{'name': 'Truvada', 'type': 'DRUG', 'description': 'A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.', 'armGroupLabels': ['Young women']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Kenya Medical Research Institute', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Desmond Tutu HIV Foundation', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Wits Reproductive Health and HIV Institute', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Connie L Celum, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Jared M Baeten, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Rachel Johnson, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data from the POWER Cohort Study will be available at the end of the project by contacting the Principal Investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Desmond Tutu HIV Foundation', 'class': 'OTHER'}, {'name': 'Wits Reproductive Health and HIV Institute', 'class': 'OTHER'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'RTI International', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof of Medicine & Global Health, Adjunct Prof of Epidemiology, SOM: Global Health', 'investigatorFullName': 'Connie Celum', 'investigatorAffiliation': 'University of Washington'}}}}