Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:33 AM
Study NCT ID:
NCT06913660
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALHIV Smartphone Game Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D012725', 'term': 'Sexual Behavior'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-02', 'size': 319073, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-15T12:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A cluster-randomized feasibility study, that involves clinic-level randomization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knowledge', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention', 'description': 'Knowledge measures will be assessed via Yes/No//I do not know survey questions and will address ART (antiretroviral therapy), HIV, sexually transmitted infections (STIs), pregnancy, and condoms. Answers to knowledge questions will be coded as 0 or 1, with higher scores indicating more accurate knowledge. Total possible score range is 0-14. A positive value for the change from baseline score will indicate an increase in knowledge from the baseline assessment.'}, {'measure': 'Change in attitudes', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention', 'description': 'Attitudes will be assessed via Likert survey questions relating to HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. Total possible score range is 0-14. A positive value for the change from baseline score will indicate an increase in desirable attitudes.'}, {'measure': 'Change in behavioral intentions', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention', 'description': 'Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk and to engage in health protective behaviors. Behavioral intention items will be scored on a 0-1 scale with higher scores indicating more intention to partake in health protective behaviors and a positive value for the change from baseline score indicating an increase in intention to engage in health protective behaviors. Total possible score range is 0-9.'}, {'measure': 'Change in self-efficacy', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention', 'description': 'Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy for condom use; to communicate with a partner about protected sex; to adhere to medication; to fully engage in care and to disclose their HIV status. Self-efficacy will be scored on a 0-1 scale with higher scores indicating stronger self-efficacy. A positive value for the change from baseline score will indicate an increase in self-efficacy since the baseline assessment. Total possible score range is 0-23.'}, {'measure': 'Change in game acceptability', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention', 'description': 'Acceptability will be assessed among intervention-arm participants via Likert scale questions. Acceptability will be scored on a 0-1 scale with higher scores indicating higher acceptability. Total possible score range is 0-12, with higher score correlating with better study outcome.'}, {'measure': 'Change in game immersion', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention', 'description': 'Immersion will be assessed among intervention-arm participants via Likert scale questions and focus on identification, transportation, and immersion. Immersion items will be scored on a 0-1 scale with higher scores indicating stronger immersion. Total possible score range is 0-18. Higher score correlates with better study outcome.'}, {'measure': 'Change in game continued use', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention', 'description': 'Continued use of the intervention over the course of the study will be assessed among intervention-arm participants via both self-report survey questions and analysis of paradata. Survey items will assess self-reported use of the game in hours at each follow-up study timepoint. Paradata analysis will calculate time in hours spent on the app for each intervention-arm participant.'}, {'measure': 'Change in game demand', 'timeFrame': 'Baseline, 9 months post-intervention', 'description': 'Demand for ongoing access to the intervention following study endline will be assessed among intervention-arm participants via Likert scale questions. Demand items will be scored on a 0-1 scale with higher scores indicating stronger demand. Total possible score range is 0-2, and higher score correlates with better study outcome.'}, {'measure': 'Change in game safety', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention', 'description': "Participants' perceived safety while in possession of the phone and app will be assess among intervention-arm participants via Likert scale questions. These will focus on physical safety as well as comfort with having an HIV-related app on the study phone. Safety items will be scored on a 0-1 scale with higher scores indicating higher perceived safety. Total possible score range is 0-4, and higher score correlates with better study outcome."}], 'secondaryOutcomes': [{'measure': 'Change in viral load (VL) from baseline', 'timeFrame': 'Baseline, mid-point (around 4 months post-intervention), and endline (9 months post-intervention)', 'description': 'VL will be assessed as "undetectable" (\\<50 copies/ml) or "detectable".'}, {'measure': 'Change in attendance at scheduled clinic visits', 'timeFrame': 'Baseline, 9 months post-intervention', 'description': 'Participant medical records (MR) will be used to review attendance.'}, {'measure': 'Change in Retention in care', 'timeFrame': 'Baseline, 9 months post-intervention', 'description': 'Retention in care will be assessed as "disengaged" (has missed the last scheduled appointment and over half of all scheduled appointment within the previous study period) or "engaged".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Smartphone Game'], 'conditions': ['Hiv', 'AIDS', 'Adolescent Behavior', 'Treatment Compliance', 'Treatment Adherence', 'Reproductive Behavior', 'Sexual Behavior']}, 'descriptionModule': {'briefSummary': 'This is a cluster-randomized controlled trial that aims to conduct comprehensive feasibility testing of a smartphone game in a sample of 120 adolescents living with HIV (ALHIV) ages 15-21 in Kisumu, Kenya, to determine whether the game influences behavioral mediators of engagement in care and sexual risk avoidance and reduction (including knowledge, attitudes, behavioral intentions, and self-efficacy).', 'detailedDescription': 'This is a cluster-randomized feasibility study that will involve clinic-level randomization of 120 ALHIV participants (12 from each of 10 clinical centers). Participants will either use the intervention (a smartphone game) or continue standard treatment and support for HIV. Participants will complete 5 surveys about behaviors, attitudes, knowledge, and self-efficacy relating to engagement in care, ART adherence, and sexual and reproductive health. They will also have blood drawn 3 times to measure their HIV viral load. Intervention-arm participants will also complete app experience surveys. A sample of intervention-arm participants will be invited to provide feedback on their experience in interviews (n=10) and/or focus groups (n=30).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Adolescents, male and female, aged 15-21 in Kisumu County (n=120)\n\nInclusion criteria:\n\n* Aged 15-21 at time of recruitment\n* Diagnosed with HIV and aware of HIV status\n* Initiated ART at least 6 months prior\n* Accesses HIV-related care at intervention arm CCC\n* VL above 50 copies/ml at last test, with last test conducted within 12 months prior to recruitment date\n\nExclusion criteria\n\n* Does not have basic literacy in English (Grade 3-4 on the Flesch-Kincaid Reading Scale)\n* Sibling to an adolescent already enrolled in study\n* Sibling to adolescent that participated in formative research\n* Participant in formative research to inform study\n* Participant in any Tumaini game activities\n* Enrolled in boarding school\n* Last recorded viral load test \\>12 months prior to recruitment date'}, 'identificationModule': {'nctId': 'NCT06913660', 'briefTitle': 'ALHIV Smartphone Game Study', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'A Smartphone Game to Increase Engagement in Care Among African Adolescents Living With HIV', 'orgStudyIdInfo': {'id': 'STUDY00002974'}, 'secondaryIdInfos': [{'id': '5R33MH124200-04', 'link': 'https://reporter.nih.gov/quickSearch/5R33MH124200-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'The intervention is an Android smartphone-based interactive narrative-driven game called MyGoals.\n\nParticipants will be instructed to play the game for at least 30 minutes for 5 days per week for the first 6 weeks and as desired thereafter.', 'interventionNames': ['Behavioral: MyGoals']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'Control-arm participants will receive the current standard of care offered at their CCC (i.e. HIV care management support and counselling received at the CCC).', 'interventionNames': ['Behavioral: Standard of care']}], 'interventions': [{'name': 'MyGoals', 'type': 'BEHAVIORAL', 'description': 'A smartphone game for ALHIV aged 15-21 yrs\n\nMyGoals includes 3 components:\n\n1. A role-playing narrative in which all players make decisions for male and female characters navigating scenarios from adolescence and early adulthood.\n2. A series of mini-games to reinforce knowledge, skills and related self-efficacy, explored in the narrative.\n3. A metanarrative component, My Story, where players will create an avatar and set personal goals.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Standard of care', 'type': 'BEHAVIORAL', 'otherNames': ['Standard of care package'], 'description': 'A minimum standard of care package will be identified prior to identification and recruitment of CCCs to ensure a comparable and adequate level of care is being offered to all control participants, since implementation of the range of support and care strategies recommended by the Kenya Ministry of Health differs by clinic.', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54840', 'city': 'Kisumu', 'country': 'Kenya', 'facility': 'KEMRI Clinical Research Centre', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'overallOfficials': [{'name': 'Kate Winskell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kate Winskell', 'investigatorAffiliation': 'Emory University'}}}}