Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT07117656
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project Vuselela Feasibility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000076064', 'term': 'Drug Misuse'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot study to understand intervention feasibility and preliminary impact on HIV and OST outcomes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the intervention', 'timeFrame': '3 and 6 months', 'description': 'Assess feasibility, acceptability, willingness and safety. This will be completed using in-depth interviews and a study-specific survey.'}, {'measure': 'Antiretroviral Therapy Therapy (ART) Adherence', 'timeFrame': '3 and 6 months', 'description': 'Medical chart review of monthly anti-retroviral therapy (ART) prescription refill data will be collected. ART is medication to manage HIV infection.'}, {'measure': 'Opioid Substitution Therapy (OST) Adherence', 'timeFrame': '3 and 6 months', 'description': 'Medical chart review of opioid substitution therapy (OST) pick-up. This measure assesses use of OST to reduce effects of addiction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV', 'Drug Users']}, 'descriptionModule': {'briefSummary': 'To develop an intervention that engages family members in supporting HIV and opioid substitution therapy treatment for those who inject drugs in South Africa, and then conduct a pilot study to understand feasibility and preliminary impact on outcomes.', 'detailedDescription': 'In response to increased injection drug use in Johannesburg, South Africa, and low ART and OST treatment retention rates, we will develop and pilot-test the intervention, Project Vuselela. The intervention is designed to engage family members in treatment support using a multi-session skill-building approach that is led by trained peer navigators. Both PLWHIDs and their family members will attend sessions to develop these skills and treatment action plans, facilitated by peer navigators. We will assess PLWHID and family acceptability of the intervention and preliminary impact on PLWHID ART and OST treatment adherence when compared to those in the current program as standard of care. The study will be conducted at Yeoville Clinic in Johannesburg, a setting with high rates of injection drug use and the only OST clinic in the city.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAim 2 PLHWID Inclusion Criteria\n\n1. Any sex or gender\n2. \\>18 years of age\n3. HIV-positive as per medical record\n4. Self-reported injection drug use behavior\n5. Have not participated in the current ART-OST program\n6. Initiating ART or OST\n7. Identifies a potential family member who can provide support\n8. Live in Johannesburg\n\nFamily Member Inclusion Criteria\n\n1. 18 years of age or older\n2. Confirms family member (parent, sibling, partner, aunt, uncle, grandparent, cousin)\n3. Knowledge of the drug using behavior by the PLWHID, but knowledge of their HIV status is not required.\n4. No recent history of self-reported drug-using behavior (\\< 5 years)\n\nExclusion Criteria:\n\nPLHWID Exclusion Criteria\n\n1. Under 18 years of age\n2. HIV-negative as per medical record\n3. Notself-reported injection drug use behavior\n4. Has participated in the current ART-OST program\n5. Taking ART or OST\n6. Cannot identify a potential family member who can provide support\n7. Does not live in Johannesburg\n\nFamily Member Exclusion Criteria\n\n1. Under 18 years of age\n2. Not a family member\n3. Does not know about drug using behavior by the PLWHID\n4. Recent history of self-reported drug-using behavior (\\< 5 years)'}, 'identificationModule': {'nctId': 'NCT07117656', 'acronym': 'PV', 'briefTitle': 'Project Vuselela Feasibility', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Developing and Pilot Testing Project Vuselela for ART and OST Engagement in Johannesburg, South Africa', 'orgStudyIdInfo': {'id': '11194429'}, 'secondaryIdInfos': [{'id': 'R34DA062367', 'link': 'https://reporter.nih.gov/quickSearch/R34DA062367', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Four sessions on coping and communication skills to improve support for treatment among family members and people who inject drugs.', 'interventionNames': ['Behavioral: Project Vuselela']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Offered current harm reduction services at clinics.'}], 'interventions': [{'name': 'Project Vuselela', 'type': 'BEHAVIORAL', 'description': 'A four session intervention with people who inject drugs and family members. Delivered three group sessions and one dyad session. Session content designed to improve coping and communication skills that will in turn improve treatment outcomes.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Albert Manyuchi, PhD', 'role': 'CONTACT', 'email': 'manyuchi@anovahealth.co.za', 'phone': '+27 71 588 5069'}], 'facility': 'Anova Health Institute', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'centralContacts': [{'name': 'Joseph A Daniels, PhD', 'role': 'CONTACT', 'email': 'Joseph.A.Daniels@asu.edu', 'phone': '206 459 5777'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}