Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-04-24 @ 4:06 PM
Study NCT ID:
NCT02905461
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 586}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Knowledge of effective contraception', 'timeFrame': '4 months', 'description': 'Score on the knowledge measure'}, {'measure': 'Perceived norms in relation to using and communicating with partners about contraception', 'timeFrame': '4 months', 'description': 'Responses to the perceived norms scales'}, {'measure': 'Personal agency in using and communicating with partners about contraception', 'timeFrame': '4 months', 'description': 'Responses to the personal agency scales'}, {'measure': 'Intention to use effective contraception', 'timeFrame': '4 months', 'description': 'Response to the intention scale'}, {'measure': "Intervention 'dose' received", 'timeFrame': '4 months', 'description': 'If participants read all, some, most or none of the messages and if they stopped the messages'}], 'primaryOutcomes': [{'measure': 'Acceptability of at least one method of effective contraception', 'timeFrame': '4 months', 'description': 'The proportion reporting that at least one method of effective contraception is acceptable (pill, intrauterine device, injection, implant, patch)'}], 'secondaryOutcomes': [{'measure': 'Use of effective contraception', 'timeFrame': '4 months', 'description': 'The proportion reporting current use of effective contraception (pill, intrauterine device, injection, implant, patch)'}, {'measure': 'Acceptability of individual effective contraceptive methods', 'timeFrame': '4 months', 'description': 'The proportion reporting that individual methods of effective contraception are acceptable (pill, intrauterine device, injection, implant, patch)'}, {'measure': 'Discontinuation of effective contraception', 'timeFrame': '4 months', 'description': 'The proportion reporting use of effective contraception at any time during the 4 months (pill, intrauterine device, injection, implant, patch)'}, {'measure': 'Service uptake', 'timeFrame': '4 months', 'description': 'The proportion reporting attending a sexual health service during the 4 months'}, {'measure': 'Unintended pregnancy', 'timeFrame': '4 months', 'description': 'The proportion reporting that they became pregnant and did not want to become pregnant during the study'}, {'measure': 'Induced abortion', 'timeFrame': '4 months', 'description': 'The proportion reporting having an abortion during the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reproductive health'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '32779730', 'type': 'DERIVED', 'citation': 'Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.'}, {'pmid': '31014358', 'type': 'DERIVED', 'citation': 'McCarthy OL, Zghayyer H, Stavridis A, Adada S, Ahamed I, Leurent B, Edwards P, Palmer M, Free C. A randomized controlled trial of an intervention delivered by mobile phone text message to increase the acceptability of effective contraception among young women in Palestine. Trials. 2019 Apr 23;20(1):228. doi: 10.1186/s13063-019-3297-4.'}, {'pmid': '28974258', 'type': 'DERIVED', 'citation': 'McCarthy OL, Wazwaz O, Jado I, Leurent B, Edwards P, Adada S, Stavridis A, Free C. An intervention delivered by text message to increase the acceptability of effective contraception among young women in Palestine: study protocol for a randomised controlled trial. Trials. 2017 Oct 3;18(1):454. doi: 10.1186/s13063-017-2191-1.'}]}, 'descriptionModule': {'briefSummary': 'This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone text message on the acceptability of effective contraception in Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4 months (intervention) or a monthly text message not about contraception (control). Participants will complete a questionnaire at baseline and 4 month follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-24 years\n* Own a personal mobile phone\n* Not using the pill, implant, injection, intrauterine device or patch\n* Live in the West Bank\n\nExclusion Criteria:\n\n* Cannot read Arabic'}, 'identificationModule': {'nctId': 'NCT02905461', 'briefTitle': 'An Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'A Randomised Controlled Trial of an Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine', 'orgStudyIdInfo': {'id': '10831'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Contraceptive text messages', 'interventionNames': ['Behavioral: Contraceptive text messages']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Text messages not about contraception', 'interventionNames': ['Other: Text messages not about contraception']}], 'interventions': [{'name': 'Contraceptive text messages', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}, {'name': 'Text messages not about contraception', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Palestinian Territories', 'facility': 'Palestinian Family Planning and Protection Association'}], 'overallOfficials': [{'name': 'Caroline Free, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Palestinian Family Planning and Protection Association', 'class': 'OTHER'}, {'name': 'International Planned Parenthood Federation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}