Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04567693
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2020-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV
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': 'joross@montefiore.org', 'phone': '718-920-7064', 'title': 'Dr. Jonathan Ross', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected on participants during their participation in the study (12 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 3, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 1, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 2, 'seriousNumAtRisk': 28, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Became pregnant during study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDra'}, {'term': 'Incarcerated during study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDra'}, {'term': 'Developed tuberculosis during study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDra'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Viral Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at 12 months after enrollment into ART care', 'description': 'Percentage of participants with suppressed viral load (less than 200 copies/ml)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Note: as the primary, intention to treat outcome, persons who did not complete the study were treated as being not virally suppressed. 3 enrolled participants were assigned to groups (one participant to the 'Early 1' group and two participants to the 'Usual Care' group), but subsequently withdrawn from the study when it became clear that they did not meet eligibility criteria. Their data were not included in the analyses."}, {'type': 'SECONDARY', 'title': 'Appointment Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'timeFrame': 'Measured at 12 months after enrollment into ART care', 'description': 'Proportion of participants that attended all pharmacy and clinical appointments', 'reportingStatus': 'POSTED', 'populationDescription': "Appointment adherence was defined in the protocol as the proportion of participants in each arm who attended all scheduled clinical appointments and ART pick-ups during the study. We planned to ascertain appointment adherence through review of participants' medical files at the conclusion of the study. During medical file review, it became apparent that scheduled appointments (i.e. next planned) were inconsistently documented. We therefore were unable to accurately ascertain this outcome."}, {'type': 'SECONDARY', 'title': 'Participant Acceptability of Reduced Time to Spaced-out Appointments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'title': 'Non-clinical', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Clinical aspects of care', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 12 months after enrollment into ART care', 'description': 'The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied \\[1\\], not satisfied \\[2\\], no opinion \\[3\\], satisfied \\[4\\], very satisfied \\[5\\]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.', 'unitOfMeasure': 'score on a scale (Likert)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Provider Acceptability of Reduced Time to Spaced-out Appointments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at 12 months after enrollment into ART care', 'description': 'Acceptability of reduced time to spaced-out appointments, as measured by the number of instances when providers overrode the study assignment. Override could only occur a maximum of one time for each participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Overriding of study assignment was only examined for participants in intervention arms (Early 1 and Early 2). 3 enrolled participants were assigned to groups (one participant to the 'Early 1' group and two participants to the 'Usual Care' group), but subsequently withdrawn from the study when it became clear that they did not meet eligibility criteria. As such, data for one 'Early 1' group participant was not included in the analyses."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Enacted and Internalized Stigmas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'title': 'Enacted stigma', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '0.10', 'groupId': 'OG002'}]}]}, {'title': 'Internalized stigma', 'categories': [{'measurements': [{'value': '1.35', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '1.27', 'spread': '0.54', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participant Health-related Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '4562', 'spread': '4034', 'groupId': 'OG000'}, {'value': '4817', 'spread': '3716', 'groupId': 'OG001'}, {'value': '4842', 'spread': '3948', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-months', 'description': 'Repeated measures analysis of participant direct and indirect costs. While we initially planned to report measurements at 1-, 6- and 12-months after enrollment in ART care, we ultimately reported direct and indirect average costs at 12 months by adding the reported costs at each of the 3 time points to calculate the cost over the entire study period, and then dividing by the number of visits to the health center.', 'unitOfMeasure': 'Rwandan Francs (currency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'ART Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 12-months after enrollment in ART care', 'description': 'Repeated measures analysis of patient self-reported ART adherence', 'unitOfMeasure': 'Days of ART missed in last 30 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'ART Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'Repeated measures analysis of patient self-reported ART adherence', 'unitOfMeasure': 'Days of ART missed in last 30 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '53.6', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '50.4', 'spread': '14.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '54.5', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '54.4', 'spread': '10.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 12 months after enrollment in ART care', 'description': 'Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Satisfaction With Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'title': 'Non-clinical', 'categories': [{'measurements': [{'value': '3.96', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '3.98', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '4.04', 'spread': '0.33', 'groupId': 'OG002'}]}]}, {'title': 'Clinical', 'categories': [{'measurements': [{'value': '3.74', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '3.72', 'spread': '0.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied \\[1\\], not satisfied \\[2\\], no opinion \\[3\\], satisfied \\[4\\], very satisfied \\[5\\]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anticipated Stigma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '2.43', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '2.73', 'spread': '0.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely \\[1\\] to Very Likely \\[5\\]), with higher scores indicating greater stigma. Items are averaged to create a composite score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anticipated Stigma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '2.41', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '2.45', 'spread': '0.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 12 months after enrollment in ART care', 'description': 'As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely \\[1\\] to Very Likely \\[5\\]), with higher scores indicating greater stigma. Items are averaged to create a composite score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Enacted and Internalized Stigmas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'classes': [{'title': 'Enacted stigma', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '.018', 'groupId': 'OG002'}]}]}, {'title': 'Internalized stigma', 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '0.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 12 months after enrollment in ART care', 'description': 'As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'FG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'FG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by investigative team (participants did not meet eligibility criteria)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'BG001', 'title': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.\n\nEarly spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits.'}, {'id': 'BG002', 'title': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30', 'spread': '10', 'groupId': 'BG000'}, {'value': '33', 'spread': '13', 'groupId': 'BG001'}, {'value': '29', 'spread': '6', 'groupId': 'BG002'}, {'value': '31', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Rwanda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ART Adherence', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.72', 'groupId': 'BG000'}, {'value': '0.03', 'spread': '0.18', 'groupId': 'BG001'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'BG002'}, {'value': '0.06', 'spread': '0.44', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Days of ART missed in last 30 days', 'unitOfMeasure': 'Days of ART missed in last 30 days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Satisfaction with care', 'classes': [{'title': 'Non-clinical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.15', 'spread': '0.34', 'groupId': 'BG000'}, {'value': '4.12', 'spread': '0.34', 'groupId': 'BG001'}, {'value': '4.11', 'spread': '0.49', 'groupId': 'BG002'}, {'value': '4.13', 'spread': '0.40', 'groupId': 'BG003'}]}]}, {'title': 'Clinical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3.81', 'spread': '0.28', 'groupId': 'BG000'}, {'value': '3.84', 'spread': '0.21', 'groupId': 'BG001'}, {'value': '3.85', 'spread': '0.24', 'groupId': 'BG002'}, {'value': '3.83', 'spread': '0.24', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied \\[1\\], not satisfied \\[2\\], no opinion \\[3\\], satisfied \\[4\\], very satisfied \\[5\\]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Enacted and Internalized Stigma', 'classes': [{'title': 'Enacted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.20', 'groupId': 'BG000'}, {'value': '1.03', 'spread': '0.09', 'groupId': 'BG001'}, {'value': '1.00', 'spread': '0.01', 'groupId': 'BG002'}, {'value': '1.00', 'spread': '0.11', 'groupId': 'BG003'}]}]}, {'title': 'Internalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.77', 'groupId': 'BG000'}, {'value': '1.62', 'spread': '0.72', 'groupId': 'BG001'}, {'value': '2.08', 'spread': '0.97', 'groupId': 'BG002'}, {'value': '1.90', 'spread': '0.80', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quality of life', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '45.0', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '45.5', 'spread': '17.7', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '16.2', 'groupId': 'BG002'}, {'value': '42.9', 'spread': '16.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Anticipated stigma', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.40', 'spread': '.074', 'groupId': 'BG000'}, {'value': '2.40', 'spread': '0.72', 'groupId': 'BG001'}, {'value': '2.43', 'spread': '0.85', 'groupId': 'BG002'}, {'value': '2.40', 'spread': '0.70', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely \\[1\\] to Very Likely \\[5\\]), with higher scores indicating greater stigma. Items are averaged to create a composite score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': "3 enrolled participants were assigned to groups (one participant to the 'Early 1' group and two participants to the 'Usual Care' group), but subsequently withdrawn from the study when it became clear that they did not meet eligibility criteria. Their data were not included in baseline analysis or any further analyses."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-23', 'size': 769790, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-21T09:31', 'hasProtocol': True}, {'date': '2020-07-01', 'size': 122882, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-12T06:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2020-09-17', 'resultsFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2020-09-25', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-03', 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Enacted and Internalized Stigmas', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma).'}, {'measure': 'Participant Health-related Costs', 'timeFrame': '12-months', 'description': 'Repeated measures analysis of participant direct and indirect costs. While we initially planned to report measurements at 1-, 6- and 12-months after enrollment in ART care, we ultimately reported direct and indirect average costs at 12 months by adding the reported costs at each of the 3 time points to calculate the cost over the entire study period, and then dividing by the number of visits to the health center.'}, {'measure': 'ART Adherence', 'timeFrame': 'Measured at 12-months after enrollment in ART care', 'description': 'Repeated measures analysis of patient self-reported ART adherence'}, {'measure': 'ART Adherence', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'Repeated measures analysis of patient self-reported ART adherence'}, {'measure': 'Perceived Quality of Life', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health.'}, {'measure': 'Perceived Quality of Life', 'timeFrame': 'Measured at 12 months after enrollment in ART care', 'description': 'Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health.'}, {'measure': 'Satisfaction With Care', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied \\[1\\], not satisfied \\[2\\], no opinion \\[3\\], satisfied \\[4\\], very satisfied \\[5\\]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.'}, {'measure': 'Anticipated Stigma', 'timeFrame': 'Measured at 6 months after enrollment in ART care', 'description': 'As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely \\[1\\] to Very Likely \\[5\\]), with higher scores indicating greater stigma. Items are averaged to create a composite score.'}, {'measure': 'Anticipated Stigma', 'timeFrame': 'Measured at 12 months after enrollment in ART care', 'description': 'As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely \\[1\\] to Very Likely \\[5\\]), with higher scores indicating greater stigma. Items are averaged to create a composite score.'}, {'measure': 'Enacted and Internalized Stigmas', 'timeFrame': 'Measured at 12 months after enrollment in ART care', 'description': 'As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma).'}], 'primaryOutcomes': [{'measure': 'Viral Suppression', 'timeFrame': 'Measured at 12 months after enrollment into ART care', 'description': 'Percentage of participants with suppressed viral load (less than 200 copies/ml)'}], 'secondaryOutcomes': [{'measure': 'Appointment Adherence', 'timeFrame': 'Measured at 12 months after enrollment into ART care', 'description': 'Proportion of participants that attended all pharmacy and clinical appointments'}, {'measure': 'Participant Acceptability of Reduced Time to Spaced-out Appointments', 'timeFrame': 'Measured at 12 months after enrollment into ART care', 'description': 'The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied \\[1\\], not satisfied \\[2\\], no opinion \\[3\\], satisfied \\[4\\], very satisfied \\[5\\]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.'}, {'measure': 'Provider Acceptability of Reduced Time to Spaced-out Appointments', 'timeFrame': 'Measured at 12 months after enrollment into ART care', 'description': 'Acceptability of reduced time to spaced-out appointments, as measured by the number of instances when providers overrode the study assignment. Override could only occur a maximum of one time for each participant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rwanda', 'Treat All', 'Antiretroviral therapy'], 'conditions': ['Hiv', 'Aids']}, 'referencesModule': {'references': [{'pmid': '38693537', 'type': 'DERIVED', 'citation': 'Ross J, Anastos K, Hill S, Remera E, Rwibasira GN, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Zhang C, Nash D, Yotebieng M, Murenzi G. Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial. BMC Health Serv Res. 2024 Apr 30;24(1):555. doi: 10.1186/s12913-024-10950-z.'}, {'pmid': '33895720', 'type': 'DERIVED', 'citation': 'Ross J, Murenzi G, Hill S, Remera E, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Habimana DS, Mugwaneza P, Zhang C, Yotebieng M, Anastos K. Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study. BMJ Open. 2021 Apr 24;11(4):e047443. doi: 10.1136/bmjopen-2020-047443.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).', 'detailedDescription': 'Most countries in sub-Saharan Africa have adopted differentiated care models for people living with HIV (PLWH), including Rwanda. Current Rwandan HIV guidelines classify newly-diagnosed PLWH as "unstable", requiring monthly visits to the health facility. Before they can advance to being "stable" patients, with spaced-out appointments that allow them to visit the health facility every three months, they must be on antiretroviral therapy (ART) for 18 months and virally suppressed on two consecutive measurements. Patients face multiple barriers to attending frequent appointments including structural issues (such as distance to the health facility, transportation cost, long waiting times) and facing stigma while traveling to and while at the health facility. Reducing the time newly-diagnosed PLWH spend in the "unstable" category could potentially decrease the burden on patients and the health facility and potentially decrease the costs of frequent appointments. The investigators therefore propose a pilot study to examine the effect of reducing the time from ART initiation to advancement to the "stable" category from 18 to 6 months. The investigators will enroll 90 patients: 30 will be randomized to 6-month advancement to spaced out appointments after 1 viral load is measured (at 5 months after enrollment in ART care) ("Early 1"); 30 will be randomized to 6-month advancement to spaced-out appointments after 2 viral loads are measured (at 3- and 5-months after enrollment in ART care) ("Early 2"); and 30 will be randomized to continue in usual care with monthly visits ("Usual care"). The investigators will compare study arms with respect to viral suppression at 12 months (primary outcome) and appointment/pharmacy adherence (secondary outcome). The investigators hypothesize that reducing the time to the "stable" category with spaced out appointments will be feasible, acceptable, not inferior to 18 months with respect to viral suppression or adherence, and will be cost-effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥15 years;\n2. newly-diagnosed with HIV (within 6 months);\n3. enrolled in care at study health facility;\n4. initiated ART.\n\nExclusion Criteria:\n\n1. planning on moving away from health center/Kigali in the next 12 months;\n2. unable to provide informed consent;\n3. enrolled in care while pregnant;\n4. co-infected with tuberculosis;\n5. concurrent known mental health or substance use disorder.'}, 'identificationModule': {'nctId': 'NCT04567693', 'briefTitle': 'Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV: a Pilot Study', 'orgStudyIdInfo': {'id': '2020-11551'}, 'secondaryIdInfos': [{'id': 'K23MH114752', 'link': 'https://reporter.nih.gov/quickSearch/K23MH114752', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early 1', 'description': 'Advance to spaced-out appointments at month 6 after a single viral load is measured.', 'interventionNames': ['Other: Early spaced-out appointments']}, {'type': 'EXPERIMENTAL', 'label': 'Early 2', 'description': 'Advance to spaced-out appointments at month 6 after two viral loads are measured.', 'interventionNames': ['Other: Early spaced-out appointments']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Do not advance to spaced-out appointments during study period'}], 'interventions': [{'name': 'Early spaced-out appointments', 'type': 'OTHER', 'description': 'Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.', 'armGroupLabels': ['Early 1', 'Early 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kigali', 'country': 'Rwanda', 'facility': 'Rwanda Military Hospital', 'geoPoint': {'lat': -1.94995, 'lon': 30.05885}}], 'overallOfficials': [{'name': 'Jonathan Ross', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'As this is a pilot study, we have elected to not allow for data to be available to other researchers for secondary analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, {'name': 'Rwanda Military Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}