Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-25 @ 1:54 AM
Study NCT ID:
NCT03054051
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
2017-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Mobile Phone Game to Prevent HIV Among Young Africans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'swinske@emory.edu', 'phone': '404-727-5286', 'title': 'Kate Winskell Enger PhD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time participants signed the consent form through the 6 week post-intervention study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number Interested in Participating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'Study participants who were randomized to either the intervention or control arm.'}], 'classes': [{'title': 'Uninterested', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Did not meet inclusion criteria', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Eligible and interested', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 1', 'description': 'To evaluate the feasibility of conducting a technology based intervention in a low resource area, the number of eligible individuals who were interested in participating after hearing about the study was examined. Letters were sent to 150 families inviting them to attend an informational meeting and 126 attended a meeting and were assess for eligibility.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes all of the individuals who expressed interest in the study by attending an informational meeting.'}, {'type': 'PRIMARY', 'title': 'Time to Recruitment of 60 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'Study participants who were randomized to either the intervention or control arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1', 'description': 'The number of days needed to recruit 60 participants.', 'unitOfMeasure': 'days', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Lost to Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of Study (Up to 4 Months)', 'description': 'The number of participants who consented to participate but then later could not be reached prior to completing all study visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Completing the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of Study (Up to 4 Months)', 'description': 'The number of participants who completed all study visits after providing consent are presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Phones Returned', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 2', 'description': 'The phone retention rate (phones not lost during the intervention) was assessed by the number of phones returned at the end of the intervention.', 'unitOfMeasure': 'phones', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number Reporting Game Was Very Fun', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 17 (post-intervention)', 'description': 'Game acceptability was assessed by asking participants how fun playing the game was. The number of participants reporting that the game was "very fun" are presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants in the intervention arm.'}, {'type': 'PRIMARY', 'title': 'Number Reporting the Game is Valuable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game.'}], 'classes': [{'title': 'Learned A Lot', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Information Very Useful Now', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Information Very Useful for Future', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 17 (post-intervention)', 'description': 'The value of the game was assessed with several questions regarding how much the participants learned and how useful the information is. The number of participants reporting that they learned a lot, found the information very useful now, and found the information very useful for the future, are presented below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants randomized to the intervention arm.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Feeling Very Safe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 17 (post-intervention)', 'description': 'Personal safety associated with being in possession of the phone was assessed by the post-intervention survey. Phones provided for the intervention were set up so that all other features were blocked and only function the phone could perform was playing the game.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Playing the Game', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game.'}], 'classes': [{'title': 'Reported played every day', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Reported played 1 hour or more every time', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 17 (post-intervention)', 'description': 'Participants were asked to play the game for at least one hour per day for 16 days. The number of participants who reported playing the game everyday and the number of participants who reported playing the game for an hour or more each time are presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants randomized to the intervention arm are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'classes': [{'title': 'Baseline score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.33', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '7.93', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline immediately post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.76', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.80', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Knowledge measures will be assessed via Yes/No survey questions and will address puberty, HIV, sexually transmitted infections (STIs), pregnancy, condoms, and alcohol and drugs. Knowledge was assessed with 15 items and responses are coded as 0 or 1. Total scores range from 0 to 15, with higher scores indicating increased knowledge. A positive value for the change from baseline score indicates an increase in knowledge from the baseline assessment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.'}, {'type': 'SECONDARY', 'title': 'Change in Self-Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'classes': [{'title': 'Baseline score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.87', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '6.22', 'spread': '2.41', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline immediately post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.95', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.03', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Self-efficacy was assessed via a 3-point Likert scale, and addressed self-efficacy to seek advice about puberty, sex, relationships; to communicate about protected sex; to reject peer, partner and adult pressure to engage in risk behaviors. Self-efficacy was assessed with 9 items which were scored as 0, 0.5 or 1. Total scores ranged from 0 to 9, with higher scores indicating increased self-efficacy. A positive value for the change from baseline score indicates an increase in self-efficacy since the baseline assessment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.'}, {'type': 'SECONDARY', 'title': 'Change in Risk Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'classes': [{'title': 'Baseline score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.67', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '2.45', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline immediately post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Risk assessment was assessed via a 3-point Likert scale, and addressed perceived risk of certain risk situations/behaviors and of contracting HIV. Risk is assessed with 4 items and responses are coded as 0, 0.5 or 1. Total scores range from 0 to 4, with higher scores indicating increased risk assessment. A positive value for the change from baseline score indicates an increase in assessing risky situations as risky.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.'}, {'type': 'SECONDARY', 'title': 'Change in Behavioral Intention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'classes': [{'title': 'Baseline score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.43', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '4.83', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline immediately post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Behavioral intention was assessed via Yes/No questions. The measure addressed intention to seek advice, to avoid risk situations, and to engage in health protective behaviors. Behavioral intention is assessed with 6 items that are scored as 0 or 1 and total scores range from 0 to 6. Higher scores in indicate more intention to partake in health protective behaviors and a positive value for the change from baseline score indicates a desirable change in intention.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.'}, {'type': 'SECONDARY', 'title': 'Change in Future Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'classes': [{'title': 'Baseline score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline immediately post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Future orientation was assessed via a single multiple-choice question (Yes/No/Maybe) and addressed perceived locus of control. Response is coded as 0, 0.5, or 1 and higher scores indicate greater understanding of future locus of control. A positive value for the change from baseline score indicates a desirable change in scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.'}, {'type': 'SECONDARY', 'title': 'Change in Perceived Social Norms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'classes': [{'title': 'Baseline score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.72', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline immediately post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Perceived social norms were assessed via a 3-point Likert and addressed sex, gender, condoms, and HIV stigma. Social norms were assessed with 6 items that are scored as 0, 0.5, or 1. Total scores range from 0 to 6 with higher scores indicating perception of more desirable social norms. A positive value for the change from baseline scores indicates a desirable change.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.'}, {'type': 'SECONDARY', 'title': 'Change in Attitudes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'classes': [{'title': 'Baseline score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.95', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '9.22', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline immediately post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 6 weeks post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.18', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '2.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Attitudes were assessed via 3-pt Likert survey questions relating to HIV stigma, condoms, sex, gender, and future orientation. Attitudes were assessed with 15 items and responses coded as 0, 0.5, or 1. Total scores ranged from 0 to 15, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score indicates an increase in desirable attitudes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from schools in Kisumu Town, western Kenya, Africa. Enrollment of participants occurred between March 20, 2017 and April 7, 2017. All study activities were completed by June 19, 2017.', 'preAssignmentDetails': 'Letters were sent to 150 parent of age-eligible children inviting them to attend informational meetings. Of the 126 who attended a meeting, 90 were interested and eligible to participate and 60 of these were randomly selected to enroll in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '1', 'groupId': 'BG000'}, {'value': '12.6', 'spread': '1', 'groupId': 'BG001'}, {'value': '12.7', 'spread': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-20', 'size': 1528176, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-09-20T16:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2017-02-13', 'resultsFirstSubmitDate': '2019-08-27', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-23', 'studyFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number Interested in Participating', 'timeFrame': 'Month 1', 'description': 'To evaluate the feasibility of conducting a technology based intervention in a low resource area, the number of eligible individuals who were interested in participating after hearing about the study was examined. Letters were sent to 150 families inviting them to attend an informational meeting and 126 attended a meeting and were assess for eligibility.'}, {'measure': 'Time to Recruitment of 60 Participants', 'timeFrame': 'Month 1', 'description': 'The number of days needed to recruit 60 participants.'}, {'measure': 'Number of Participants Lost to Follow Up', 'timeFrame': 'Duration of Study (Up to 4 Months)', 'description': 'The number of participants who consented to participate but then later could not be reached prior to completing all study visits.'}, {'measure': 'Number of Participants Completing the Study', 'timeFrame': 'Duration of Study (Up to 4 Months)', 'description': 'The number of participants who completed all study visits after providing consent are presented here.'}, {'measure': 'Number of Phones Returned', 'timeFrame': 'Month 2', 'description': 'The phone retention rate (phones not lost during the intervention) was assessed by the number of phones returned at the end of the intervention.'}, {'measure': 'Number Reporting Game Was Very Fun', 'timeFrame': 'Day 17 (post-intervention)', 'description': 'Game acceptability was assessed by asking participants how fun playing the game was. The number of participants reporting that the game was "very fun" are presented here.'}, {'measure': 'Number Reporting the Game is Valuable', 'timeFrame': 'Day 17 (post-intervention)', 'description': 'The value of the game was assessed with several questions regarding how much the participants learned and how useful the information is. The number of participants reporting that they learned a lot, found the information very useful now, and found the information very useful for the future, are presented below.'}, {'measure': 'Number of Participants Feeling Very Safe', 'timeFrame': 'Day 17 (post-intervention)', 'description': 'Personal safety associated with being in possession of the phone was assessed by the post-intervention survey. Phones provided for the intervention were set up so that all other features were blocked and only function the phone could perform was playing the game.'}, {'measure': 'Number of Participants Playing the Game', 'timeFrame': 'Day 17 (post-intervention)', 'description': 'Participants were asked to play the game for at least one hour per day for 16 days. The number of participants who reported playing the game everyday and the number of participants who reported playing the game for an hour or more each time are presented here.'}], 'secondaryOutcomes': [{'measure': 'Change in Knowledge', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Knowledge measures will be assessed via Yes/No survey questions and will address puberty, HIV, sexually transmitted infections (STIs), pregnancy, condoms, and alcohol and drugs. Knowledge was assessed with 15 items and responses are coded as 0 or 1. Total scores range from 0 to 15, with higher scores indicating increased knowledge. A positive value for the change from baseline score indicates an increase in knowledge from the baseline assessment.'}, {'measure': 'Change in Self-Efficacy', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Self-efficacy was assessed via a 3-point Likert scale, and addressed self-efficacy to seek advice about puberty, sex, relationships; to communicate about protected sex; to reject peer, partner and adult pressure to engage in risk behaviors. Self-efficacy was assessed with 9 items which were scored as 0, 0.5 or 1. Total scores ranged from 0 to 9, with higher scores indicating increased self-efficacy. A positive value for the change from baseline score indicates an increase in self-efficacy since the baseline assessment.'}, {'measure': 'Change in Risk Assessment', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Risk assessment was assessed via a 3-point Likert scale, and addressed perceived risk of certain risk situations/behaviors and of contracting HIV. Risk is assessed with 4 items and responses are coded as 0, 0.5 or 1. Total scores range from 0 to 4, with higher scores indicating increased risk assessment. A positive value for the change from baseline score indicates an increase in assessing risky situations as risky.'}, {'measure': 'Change in Behavioral Intention', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Behavioral intention was assessed via Yes/No questions. The measure addressed intention to seek advice, to avoid risk situations, and to engage in health protective behaviors. Behavioral intention is assessed with 6 items that are scored as 0 or 1 and total scores range from 0 to 6. Higher scores in indicate more intention to partake in health protective behaviors and a positive value for the change from baseline score indicates a desirable change in intention.'}, {'measure': 'Change in Future Orientation', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Future orientation was assessed via a single multiple-choice question (Yes/No/Maybe) and addressed perceived locus of control. Response is coded as 0, 0.5, or 1 and higher scores indicate greater understanding of future locus of control. A positive value for the change from baseline score indicates a desirable change in scores.'}, {'measure': 'Change in Perceived Social Norms', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Perceived social norms were assessed via a 3-point Likert and addressed sex, gender, condoms, and HIV stigma. Social norms were assessed with 6 items that are scored as 0, 0.5, or 1. Total scores range from 0 to 6 with higher scores indicating perception of more desirable social norms. A positive value for the change from baseline scores indicates a desirable change.'}, {'measure': 'Change in Attitudes', 'timeFrame': 'Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention', 'description': 'Attitudes were assessed via 3-pt Likert survey questions relating to HIV stigma, condoms, sex, gender, and future orientation. Attitudes were assessed with 15 items and responses coded as 0, 0.5, or 1. Total scores ranged from 0 to 15, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score indicates an increase in desirable attitudes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV prevention', 'Preadolescence', 'Mobile phone game', 'Feasibility'], 'conditions': ['HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '30068501', 'type': 'RESULT', 'citation': "Winskell K, Sabben G, Akelo V, Ondeng'e K, Obong'o C, Stephenson R, Warhol D, Mudhune V. A Smartphone Game-Based Intervention (Tumaini) to Prevent HIV Among Young Africans: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 1;6(8):e10482. doi: 10.2196/10482."}, {'pmid': '30916661', 'type': 'RESULT', 'citation': "Sabben G, Akelo V, Mudhune V, Ondeng'e K, Ndivo R, Stephenson R, Winskell K. A Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Pilot Study of a Mobile Intervention. JMIR Res Protoc. 2019 Mar 27;8(3):e11209. doi: 10.2196/11209."}, {'pmid': '31115348', 'type': 'RESULT', 'citation': "Sabben G, Mudhune V, Ondeng'e K, Odero I, Ndivo R, Akelo V, Winskell K. A Smartphone Game to Prevent HIV Among Young Africans (Tumaini): Assessing Intervention and Study Acceptability Among Adolescents and Their Parents in a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 May 21;7(5):e13049. doi: 10.2196/13049."}]}, 'descriptionModule': {'briefSummary': 'This project will test the feasibility of an electronic game to prevent HIV among African preadolescents, delivered via inexpensive Android smart phones. In order to collect feasibility data for a future randomized controlled trial, this study involves the pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya, where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be carried out with the Kenya Medical Research Institute (KEMRI).', 'detailedDescription': 'This project will test the feasibility of an electronic game for preadolescents, delivered via inexpensive Android smart phones. The game is informed by socio-behavioral and pedagogical theories, evidence-based practice, and formative research on youth sexual culture in sub-Saharan Africa. It is designed to: educate young players, ages 11-14, about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV, sexually transmitted infections (STIs), and unintended pregnancy; challenge harmful gender norms and HIV stigma; and foster dialogue with parents and caregivers.\n\nThe proposed feasibility test will be conducted in Western Kenya. Sixty preadolescents will be enrolled in the trial, 30 in the study arm and 30 in the control arm. The Kenya Medical Research Institute (KEMRI) has established community advisory boards (CABs) in Kisumu, which will be available to the proposed study.\n\nData collection will take place at KEMRI offices, health clinics, or in the meeting room of a local community-based organization (CBO). In addition, data on game-play will be automatically collected on mobile phones given to preadolescent study participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Aged 11-14 at time of recruitment\n* Resident in Nyanza region, Kenya\n* Having basic literacy in English\n* Only one child enrolled per family\n\nExclusion criteria:\n\n* Aged \\<11 or \\>14 at time of recruitment\n* Not resident in Nyanza region, Kenya\n* Without basic literacy in English\n* Sibling to a child already enrolled in the study\n* Participant in formative research to inform the study'}, 'identificationModule': {'nctId': 'NCT03054051', 'briefTitle': 'A Mobile Phone Game to Prevent HIV Among Young Africans', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'A Mobile Phone Game to Prevent HIV Among Young Africans', 'orgStudyIdInfo': {'id': 'IRB00081150'}, 'secondaryIdInfos': [{'id': '5R34MH106368', 'link': 'https://reporter.nih.gov/quickSearch/5R34MH106368', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tumaini Mobile Phone Game', 'description': 'Participants randomized to this arm will be invited to play the Tumaini game.', 'interventionNames': ['Behavioral: Tumaini Mobile Phone Game']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Participants randomized to this arm will receive no intervention beyond the current standard of care for sexual education.'}], 'interventions': [{'name': 'Tumaini Mobile Phone Game', 'type': 'BEHAVIORAL', 'description': 'Tumaini is a scenario-based role-playing game application, optimized for use on low-cost Android smartphones. Participants will be invited to play the game for at least ten hours over a period of three weeks. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma and harmful gender norms; and promote parent-child dialogue.', 'armGroupLabels': ['Tumaini Mobile Phone Game']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Kenya Medical Research Institute', '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'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kate Winskell', 'investigatorAffiliation': 'Emory University'}}}}