Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT04206527
Status:
COMPLETED
Last Update Posted:
2019-12-20
First Post:
2019-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Person-Centered Care for Family Planning in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2019-12-17', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Person-centered Family Planning Scale Score', 'timeFrame': '3-months after first FP counseling with ASHA', 'description': 'Survey conducted with women: self-report of experiences of care. Possible range 0-43; higher the score the better the experience of care'}, {'measure': 'Experience of providing FP counseling', 'timeFrame': 'at least 3-months after FP training', 'description': 'In-depth interviews with ASHAs from intervention and control arms to understand experience providing FP counseling'}], 'secondaryOutcomes': [{'measure': 'Uptake of Family Planning', 'timeFrame': '3-months after first FP counseling with ASHA', 'description': "Self-report of uptake of a FP method; Yes/No/I Don't remember"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Person-Centered Care'], 'conditions': ['Family Planning']}, 'referencesModule': {'references': [{'pmid': '33308230', 'type': 'DERIVED', 'citation': 'Diamond-Smith N, McDonell C, Sahu AB, Roy KP, Giessler K. A mixed-methods evaluation of the impact of a person-centered family planning intervention for community health workers on family planning outcomes in India. BMC Health Serv Res. 2020 Dec 11;20(1):1139. doi: 10.1186/s12913-020-05995-9.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of a training to ASHAs on person-centered care (PCC) for family planning (FP).', 'detailedDescription': 'ASHAs will be provided with a training on family planning (FP) counseling and method options. Half of the group will receive additional trainings on person-centered care (PCC) principles and respectful care while the other half of the group will not receive this additional training. Women working with both the control ASHAs (FP trained) and Interventions ASHAs (FP+PCC trained) will be surveyed following their interactions with the ASHA to understand the quality of their experience with the ASHA and whether the woman has taken up a FP method of her choice following interaction with the ASHA.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-49\n* Consented/agreed to participate\n* Has met with a control or intervention ASHA at least once in the previous three months\n\nExclusion Criteria:\n\n* Not a women aged 18-49\n* Did not consent/agree to participate\n* Has not met with a control or intervention ASHA at least once in the previous three months'}, 'identificationModule': {'nctId': 'NCT04206527', 'acronym': 'SPARQ_FPI', 'briefTitle': 'Improving Person-Centered Care for Family Planning in India', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Strengthening People-centered Accessibility, Respect, and Quality for Family Planning Services in India', 'orgStudyIdInfo': {'id': '18-25950'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention - Women', 'description': 'Women who receive enhanced FP counseling from an ASHA', 'interventionNames': ['Behavioral: Training of AHSAs on PCC for FP']}, {'type': 'NO_INTERVENTION', 'label': 'Control - Women', 'description': 'Women who receive standard FP counseling from an ASHA'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention - ASHA', 'description': 'ASHA who receive enhanced FP counseling training', 'interventionNames': ['Behavioral: Enhanced FP training']}, {'type': 'NO_INTERVENTION', 'label': 'Control ASHA', 'description': 'ASHA who receive standard FP training'}], 'interventions': [{'name': 'Training of AHSAs on PCC for FP', 'type': 'BEHAVIORAL', 'description': 'ASHAs provided with training on FP methods and counseling plus PCC for FP', 'armGroupLabels': ['Intervention - Women']}, {'name': 'Enhanced FP training', 'type': 'BEHAVIORAL', 'description': 'Participation in an enhanced FP training including PCC', 'armGroupLabels': ['Intervention - ASHA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Population Services International', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}], 'overallOfficials': [{'name': 'Nadia Diamond-Smith, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Population Services International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}