Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT06316102
Status:
COMPLETED
Last Update Posted:
2025-11-06
First Post:
2024-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-08', 'size': 489671, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-03T14:53', 'hasProtocol': True}, {'date': '2024-03-21', 'size': 86302, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-22T10:41', 'hasProtocol': False}, {'date': '2023-04-21', 'size': 165347, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-02T16:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral Suppression (HIV), 6 months', 'timeFrame': '6 months', 'description': 'For viral load assessments of HIV, a 10 mL tube of ethylenediaminetetraacetic acid anti-coagulated blood will be drawn.\n\n\\<400 copies/mL= viral suppression \\>=400 copies/mL=no viral suppression'}, {'measure': 'Viral Suppression (HIV), 1 year', 'timeFrame': '1 year', 'description': 'For viral load assessments of HIV, a 10 mL tube of ethylenediaminetetraacetic acid anti-coagulated blood will be drawn.\n\n\\<400 copies/mL= viral suppression \\>=400 copies/mL=no viral suppression'}, {'measure': 'Retention in HIV care, 6 months', 'timeFrame': '6 months', 'description': 'Participants who have received HIV care will answer the question:\n\nIn the past 6 months, how many HIV appointments have you missed? 0 = Retention in HIV care \\>0 = No retention in HIV care'}, {'measure': 'Retention in HIV care, 1 year', 'timeFrame': '1 year', 'description': 'Participants who have received HIV care will answer the question:\n\nIn the past 6 months, how many HIV appointments have you missed? 0 = Retention in HIV care \\>0 = No retention in HIV care'}, {'measure': 'Antiretroviral therapy adherence, 6 months', 'timeFrame': '6 months', 'description': 'Participants on antiretroviral therapy will be asked:\n\nDuring the last 4 days, how many days did you not take your entire antiretroviral therapy dose? 0 = No antiretroviral therapy interruption \\>0 = Antiretroviral therapy interruption'}, {'measure': 'Antiretroviral therapy adherence, 1 year', 'timeFrame': '1 year', 'description': 'Participants on antiretroviral therapy will be asked:\n\nDuring the last 4 days, how many days did you not take your entire antiretroviral therapy dose? 0 = No antiretroviral therapy interruption \\>0 = Antiretroviral therapy interruption'}, {'measure': 'Antiretroviral therapy interruption, 6 months', 'timeFrame': '6 months', 'description': 'Participants on antiretroviral therapy will be asked:\n\nIn the past 6 months, have you stopped or suspended your antiretrovirals?\n\nNo = No antiretroviral therapy interruption Yes = Antiretroviral therapy interruption'}, {'measure': 'Antiretroviral therapy interruption, 1 year', 'timeFrame': '1 year', 'description': 'Participants on antiretroviral therapy will be asked:\n\nIn the past 6 months, have you stopped or suspended your antiretrovirals?\n\nNo = No antiretroviral therapy interruption Yes = Antiretroviral therapy interruption'}], 'secondaryOutcomes': [{'measure': 'Depression, 6 months', 'timeFrame': '6 months', 'description': 'Patient Health Questionnaire-9: 0-9=No depressive symptoms; 10-27=depressive symptoms.\n\nResponse options:\n\nNo day, Several days, More than half the days, Almost every day\n\nItems about previous 2 weeks:\n\nYou have little interest or pleasure in doing things. You have felt down, depressed, or hopeless. You have had difficulty staying or falling asleep or you have slept too much You have felt tired or with little energy You have had little appetite or have eaten excessively You have felt badly about yourself - or you think you are a failure or that you have done wrong to yourself or your family You have had difficulty concentrating on certain activities, like watching tv or movies You have moved or talked so slowly that other people noticed it You have been so restless or agitated that you have been moving more than normal and others have noticed it You have thought that you would be better off dead or you have thought about harming yourself in some way'}, {'measure': 'Depression, 1 year', 'timeFrame': '1 year', 'description': 'Patient Health Questionnaire-9: 0-9=No depressive symptoms; 10-27=depressive symptoms.\n\nResponse options:\n\nNo day, Several days, More than half the days, Almost every day\n\nItems about previous 2 weeks:\n\nYou have little interest or pleasure in doing things. You have felt down, depressed, or hopeless. You have had difficulty staying or falling asleep or you have slept too much You have felt tired or with little energy You have had little appetite or have eaten excessively You have felt badly about yourself - or you think you are a failure or that you have done wrong to yourself or your family You have had difficulty concentrating on certain activities, like watching tv or movies You have moved or talked so slowly that other people noticed it You have been so restless or agitated that you have been moving more than normal and others have noticed it You have thought that you would be better off dead or you have thought about harming yourself in some way'}, {'measure': 'Anxiety, 6 months', 'timeFrame': '6 months', 'description': "positive screening for anxiety symptoms in the previous 2 weeks. Measured using the Hospital Anxiety and Depression Scale - Anxiety which consists of 7 items.\n\nScore 0-7 = No anxiety symptoms Score 8-21 = anxiety symptoms\n\nItems:\n\nI feel tense or nervous\n\n* All the times, many times, sometimes, never I have a strange feeling, as if there were butterflies in my stomach\n* Never, on occasion, frequently, very often I have a sense of fear, as if something horrible were going to happen to me\n* Definitely and it is very strong, yes but no too strongly, a little but it doesn't worry me, never I feel restless, as if I couldn't stop moving\n* A lot, a good deal, not much, never My mind is full of worries\n* most of the time, frequently, sometimes but not often, only on occasion Sudden feelings of panic come over me\n* very frequently, often, not often, rarely I can sit comfortably and feel relaxed\n* always, generally, not often, never"}, {'measure': 'Anxiety, 1 year', 'timeFrame': '1 year', 'description': "positive screening for anxiety symptoms in the previous 2 weeks. Measured using the Hospital Anxiety and Depression Scale - Anxiety which consists of 7 items.\n\nScore 0-7 = No anxiety symptoms Score 8-21 = anxiety symptoms\n\nItems:\n\nI feel tense or nervous\n\n* All the times, many times, sometimes, never I have a strange feeling, as if there were butterflies in my stomach\n* Never, on occasion, frequently, very often I have a sense of fear, as if something horrible were going to happen to me\n* Definitely and it is very strong, yes but no too strongly, a little but it doesn't worry me, never I feel restless, as if I couldn't stop moving\n* A lot, a good deal, not much, never My mind is full of worries\n* most of the time, frequently, sometimes but not often, only on occasion Sudden feelings of panic come over me\n* very frequently, often, not often, rarely I can sit comfortably and feel relaxed\n* always, generally, not often, never"}, {'measure': 'Substance use, 6 months', 'timeFrame': '6 months', 'description': 'Yes = used any type of drug in the previous 6 months No = did not use any type of drug in the previous 6 months'}, {'measure': 'Substance use, 1 year', 'timeFrame': '1 year', 'description': 'Yes = used any type of drug in the previous 6 months No = did not use any type of drug in the previous 6 months'}, {'measure': 'Binge drinking, 6 months', 'timeFrame': '6 months', 'description': 'No = consumes 6+ drinks on one occasion less than once a month Yes = consume 6+ drinks on one occasion at least monthly'}, {'measure': 'Binge drinking, 1 year', 'timeFrame': '1 year', 'description': 'No = consumes 6+ drinks on one occasion less than once a month Yes = consume 6+ drinks on one occasion at least monthly'}, {'measure': 'Self-esteem, 6 months', 'timeFrame': '6 months', 'description': "Rosenberg self-esteem scale; analyzed as a continuous variable. A higher score indicates higher self-esteem\n\nResponse options:\n\nTotally agree = 4 Agree = 3 Disagree = 2 Totally disagree = 1\n\nItems:\n\nIn general, I am satisfied with myself Sometimes, I think I am not good at anything I feel like I have some good qualities I am capable of doing things as well as the majority of people I feel like I don't have many things to feel proud about Sometimes I feel really useless I feel like I am worth less than most people I wish to respect myself more Definitively, I think I am a failure I have a positive attitude toward myself\n\n\\*Items 2, 5, 6, 8, 9 are reverse scored."}, {'measure': 'Self-esteem, 1 year', 'timeFrame': '1 year', 'description': "Rosenberg self-esteem scale; analyzed as a continuous variable. A higher score indicates higher self-esteem\n\nResponse options:\n\nTotally agree = 4 Agree = 3 Disagree = 2 Totally disagree = 1\n\nItems:\n\nIn general, I am satisfied with myself Sometimes, I think I am not good at anything I feel like I have some good qualities I am capable of doing things as well as the majority of people I feel like I don't have many things to feel proud about Sometimes I feel really useless I feel like I am worth less than most people I wish to respect myself more Definitively, I think I am a failure I have a positive attitude toward myself\n\n\\*Items 2, 5, 6, 8, 9 are reverse scored."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transgender women', 'transfeminine people', 'HIV', 'Stigma', 'Cohesion', 'Multilevel intervention'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'This study includes an adapted multilevel intervention, Abriendo Puertas (Opening Doors), including individual counseling, peer navigation, and community mobilization for transfeminine people living with HIV in the Dominican Republic using an iterative consultation process. Prior to this randomized controlled trial, feasibility and initial effects on HIV care and treatment behaviors were assessed with 30 trans women living with HIV (no control group) and documented positive trends in antiretroviral therapy use (70% to 85%, p=0.03), missed care appointments (35% to 20%, p=0.39) and antiretroviral therapy adherence (86% to 96%, p=0.50). Participants emphasized that trusting intervention staff and being treated with respect in individual sessions allowed them to improve self-esteem. Limited trust and cohesion among trans women, however, inhibited more extensive engagement with peer navigation and community activities. In response, the study team identified two key modifications to strengthen and further tailor the intervention for transfeminine people living with HIV: 1) integrate more gender affirming content, including with providers and 2) focus on building trust among transfeminine people through sequential implementation of individual and then community components. The purpose of the proposed study is to conduct a pilot randomized trial of the Gender-affirming Abriendo Puertas intervention. In Aim 1, the preliminary efficacy of the Gender-affirming Abriendo Puertas intervention on viral suppression among transfeminine people randomized to the intervention compared to those randomized to control will be assessed. The research study will randomly assign transfeminine people living with HIV to the Gender-affirming Abriendo Puertas intervention (n=60) (individual counseling, peer navigation, provider training, and community support building) or control group (n=60). There will be baseline, 6, and 12-month surveys and viral load assessments to assess differences across study arms. In Aim 2, the study team will examine pathways of influence (e.g. decreased stigma, increased cohesion) and experiences with the intervention to identify specific areas for improvement and scale up. Longitudinal qualitative interviews will be conducted at baseline, 6, and 12 months with 20 intervention participants. Together with surveys, the study team will assess how Gender-affirming Abriendo Puertas participation affects pathways between stigma, cohesion, and HIV outcomes. The study team will also elicit experiences and recommendations from providers and intervention staff in focus groups at 6 (n=2) and 12 months (n=2).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participants must have a transfeminine identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being at least 18 years of age;\n* assigned male at birth but self-identify as transfeminine (using locally appropriate terminology);\n* confirmed HIV positive diagnosis using a single rapid test\n\nExclusion Criteria:\n\n* There is a small group of individuals (approximately 20) who participated in a previous adaptation study to develop the intervention that will be tested in the proposed study. These individuals will not be eligible since they have already been exposed to an earlier version of the intervention.'}, 'identificationModule': {'nctId': 'NCT06316102', 'briefTitle': 'Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Piloting a Multilevel Intervention to Promote Viral Suppression Among Transgender Women Living With HIV in Santo Domingo', 'orgStudyIdInfo': {'id': '22-3282'}, 'secondaryIdInfos': [{'id': 'R34MH129218', 'link': 'https://reporter.nih.gov/quickSearch/R34MH129218', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.'}, {'type': 'EXPERIMENTAL', 'label': 'Gender Affirming Abriendo Puertas (Opening Doors) (GAP)', 'description': 'This group will be exposed to all four components of the multilevel intervention.\n\n1\\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building.', 'interventionNames': ['Behavioral: Gender Affirming Abriendo Puertas (Opening Doors) (GAP)']}], 'interventions': [{'name': 'Gender Affirming Abriendo Puertas (Opening Doors) (GAP)', 'type': 'BEHAVIORAL', 'description': 'Multilevel intervention with 4 components', 'armGroupLabels': ['Gender Affirming Abriendo Puertas (Opening Doors) (GAP)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Instituto Dermatológico y Cirugía de Piel (IDCP)', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}], 'overallOfficials': [{'name': 'Clare Barrington, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Dermatológico y Cirugía de Piel (IDCP)', 'class': 'UNKNOWN'}, {'name': 'George Washington University', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}