Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-01 @ 7:49 PM
Study NCT ID:
NCT02527135
Status:
COMPLETED
Last Update Posted:
2015-08-18
First Post:
2015-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Text Messaging to Improve HIV Testing Among Young Women in Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First HIV test', 'timeFrame': 'End of study (6 months after enrollment)', 'description': 'Time to first reported HIV test will be compared between the two study arms'}], 'secondaryOutcomes': [{'measure': 'Reported sexual behaviour patterns', 'timeFrame': 'End of study (6 months after enrollment)', 'description': 'Sexual behaviour data (number of new sexual partners, concurrent sexual partnerships and number of sex acts where condoms are used) was collected via a text message survey monthly during study follow up and responses will be compared between the two study arms'}, {'measure': 'Self perception of risk', 'timeFrame': 'End of study (6 months after enrollment)', 'description': 'Self perception of HIV risk in both arms will be compared against HIV testing habits and sexual partnerships'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SMS', 'Text messages', 'Young women', 'HIV'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether regularly scheduled HIV sensitization text messages (SMS) are effective in increasing HIV testing rates among young women in Kenya.', 'detailedDescription': 'In Kenya, women have higher rates of infection (6.9%) than men (4.4%) and young women aged 15-24 years are over three times more likely to be infected than young men of the same age group. HIV testing and counseling remains critical to identifying new infections and preventing the spread of HIV but many young women do not test and still continue to engage in high risk behavior.\n\nHIV programs have begun to leverage mobile phones and text messages to increase the reach and scale of interventions. Kenya currently has 32.2 million mobile phone subscribers, representing a 79.2% country penetration. Text messages have been used successfully in Kenya for marketing purposes and have even been demonstrated to increase antiretroviral (ART) adherence. Despite advances in mobile-based applications to improve issues in health, none of these health applications have yet been able to reach the scale of mobile phone-based financial products in Kenya.\n\nGiven the potential synergies of text message use and need for HIV testing, a randomized quasi-experimental study was conducted to test whether weekly text messages encouraging HIV testing and improving HIV awareness would increase HIV testing, enhance HIV risk perception and reduce high risk behaviour among young women 18-24 years old in a predominantly rural region in Kenya.\n\nWomen in the intervention arm received access to a suite of HIV sensitization text messages sent weekly to increase their awareness of HIV and encourage them to test with the option of texting back for more information to a maximum of three times per week. Women in the control arm did not receive these messages. All women were followed up for six months with monthly SMS surveys collecting data on their HIV testing practices, sexual behaviour and risk perception.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Own a mobile phone which they don't share and which operates on a telecom provider supported by our SMS platform\n* Be HIV uninfected (by self report) or not know their HIV status\n* Report not having tested for HIV in the preceding 12 months\n* Know how to send and receive SMS\n* Must consent to the study\n* Have regular access to electricity for charging a cell phone\n\nExclusion Criteria:\n\n* Did not consent to the study\n* Did not meet inclusion criteria"}, 'identificationModule': {'nctId': 'NCT02527135', 'acronym': 'T2T', 'briefTitle': 'Text Messaging to Improve HIV Testing Among Young Women in Kenya', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Evaluating Feasibility and Potential Impact of Text Messages on HIV Awareness Among Young Women in Rural Kenya: a Pilot Study', 'orgStudyIdInfo': {'id': '49533-EJ'}, 'secondaryIdInfos': [{'id': 'D43TW009580', 'link': 'https://reporter.nih.gov/quickSearch/D43TW009580', 'type': 'NIH'}, {'id': 'S4 0254-01', 'type': 'OTHER_GRANT', 'domain': 'Grand Challenges Canada'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioural', 'description': 'Intervention arm receiving weekly HIV sensitization text messages', 'interventionNames': ['Behavioral: Weekly HIV sensitization text messages']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No weekly messages were sent to this group'}], 'interventions': [{'name': 'Weekly HIV sensitization text messages', 'type': 'BEHAVIORAL', 'description': 'Weekly HIV sensitization text messages with option to text back up to 3 times per week for additional messages. Message topics included pregnancy, condoms, sexually transmitted infections, contraceptives, anal sex and personal risk of HIV. All messages ended with the phrase "Get tested for HIV".', 'armGroupLabels': ['Behavioural']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Nairobi', 'state': 'Nairobi County', 'country': 'Kenya', 'facility': 'Partners in Health and Research Development (PHRD)', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}], 'overallOfficials': [{'name': 'Njambi Njuguna, MBChB,MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington; Kenyatta National Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grand Challenges Canada', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Njambi Njuguna', 'investigatorAffiliation': 'University of Washington'}}}}