Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:19 AM
Study NCT ID:
NCT07439003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Risk Identification and Decision Guidance for HIV Engagement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visit attendance', 'timeFrame': '1-6 months following exposure to retention toolkit', 'description': 'Attendance at the next visit scheduled to occur after the visit at which participant was exposed to the retention toolkit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'retention', 'guidelines', 'South Africa'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'Despite much progress towards reaching UNAIDS goals for HIV treatment, disengagement from care remains one of the biggest obstacles to HIV elimination. In many African countries, including South Africa, the early treatment period (first six months after starting or re-starting antiretroviral therapy (ART)) is the interval with the highest risk of treatment interruption and disengagement, but until recently, this period had received relatively little attention from researchers and policy makers. The Retain6 project was launched in 2021 to generate data about the early treatment period, propose potential improvements to guidelines and models of care, and conduct preliminary tests of some potential interventions. Since then, Retain6 has collected detailed data about, among other topics:\n\n* Patient-level preferences, barriers, and facilitators of care during the first six months to help predict interruption risks and develop relevant interventions (PREFER survey, protocol M220440 (Wits HREC), H-42726 (BU IRB)\n* Predictors of risks of treatment interruption during the early treatment period and characteristics of patients most likely to experience interruptions, with an improved risk assessment approach for use at primary clinic level (PREDICT model, protocol M210472)\n* Interventions currently available at primary healthcare clinics to improve engagement in care, to match interventions to risks\n* Current facility compliance with South Africa\'s 2023 HIV treatment guidelines (FIRST-HIV, protocol 250409)\n* Provider views of retention in care and potential ways to improve it, to understand facility barriers to implementing guidelines (FIRST-HIV, protocol 250409)\n* Effectiveness of tracing interventions following an interruption, to optimize tracing procedures once disengagement occurs (GREAT-South Africa, protocol M2409113).\n\nUnder the proposed BRIDGE (Behavioral Risk Identification and Decision Guidance for Engagement) protocol, the investigators aim to synthesize the data listed above to create and test a client retention toolkit comprising a package of targeted, light-touch interventions that aim to improve outcomes during the early treatment period. The retention toolkit is expected to include:\n\n* An updated adherence risk/vulnerability assessment tool for use by clients and providers during consultations to identify clients vulnerable to disengagement from care\n* A "menu" of available interventions that can be matched to identified vulnerability factors for disengagement and allow patients to choose what they believe will be most effective for them\n* A "treatment roadmap" to help new and re-starting ART patients understand and adhere to treatment schedules\n* A WhatsApp based tool, AI Coach, developed by external colleagues to provide confidential and empathetic support and information after treatment initiation.\n* An improved process for identifying patients eligible for tracing and monitoring tracing results.\n* A co-designed, user-friendly checklist/job aid to support providers in adhering to the 2023 ART guidelines during early treatment.\n\nThis package is currently being co-designed with key stakeholders, including the National Department of Health, and is intended to be implemented within the existing systems and require minimal additional resources. On completion of the co-design process, the investigators will conduct a pilot assessment of the retention toolkit to describe acceptability, feasibility, uptake, and preliminary impact on near-term outcomes (attendance at next scheduled visit) at a selected set of primary healthcare clinics in South Africa. The study procedures will combine secondary analysis of de-identified medical record data and qualitative data collection among patients and providers. Data collection will take place during the first half of 2026, with a waiver of consent requested for medical record data and written informed consent for qualitative data collection. The maximum total sample size for the medical record data will be 30,000 patients and for the qualitative data collection will be 180 patients and 90 providers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Groups 1 and 2 will comprise ART clients initiating or re-initiating ART or on ART at one of the study sites during the pilot evaluation period. Group 3 will comprise healthcare providers at the study sites who were exposed to the intervention (implemented the retention toolkit).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1:\n\n* ≥18 years old at treatment initiation or re-initiation\n* Initiating ART (newly or re-engaging after a period of interruption) or currently receiving ART at one of the participating study sites.\n\nGroup 2:\n\n* Seeking care at an intervention site during their early treatment period\n* Reachable at telephone (mobile) number provided\n* Consented to participate in qualitative data collection\n\nGroup 3:\n\n* Employed by DOH or an implementing partner at a study site\n* Trained and participated in delivering the intervention\n* Consented to participate in qualitative data collection\n\nExclusion Criteria:\n\nNo exclusion criteria for any group.'}, 'identificationModule': {'nctId': 'NCT07439003', 'acronym': 'BRIDGE', 'briefTitle': 'Behavioral Risk Identification and Decision Guidance for HIV Engagement', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Behavioral Risk Identification and Decision Guidance for Engagement', 'orgStudyIdInfo': {'id': 'H-46408'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ART clients seeking care at study sites', 'description': 'Adult clients initiating ART (newly or re-engaging after a period of interruption) or currently receiving ART at one of the participating study sites', 'interventionNames': ['Behavioral: Retention toolkit to improve HIV treatment outcomes during the early treatment period']}, {'label': 'ART clients exposed to intervention', 'description': 'Adult ART clients who were exposed to the intervention during a routine clinic visit', 'interventionNames': ['Behavioral: Retention toolkit to improve HIV treatment outcomes during the early treatment period']}, {'label': 'Providers exposed to the intervention', 'description': 'Healthcare service providers at implementation facilities who participated in implementing the intervention', 'interventionNames': ['Behavioral: Retention toolkit to improve HIV treatment outcomes during the early treatment period']}], 'interventions': [{'name': 'Retention toolkit to improve HIV treatment outcomes during the early treatment period', 'type': 'BEHAVIORAL', 'description': "The proposed retention toolkit to be tested in this study has six components, all of which are intended to be low-cost, light-touch changes to standard of care that are designed to help patients overcome barriers to retention in the early treatment period; can be implemented by existing public sector clinic staff with existing resources; and can be evaluated using a combination of routinely collected medical record data and qualitative surveys. The toolkit will be implemented at facility level, such that all clients seeking relevant services will be exposed to it during the pilot period. The toolkit's components are:\n\n* Risk/vulnerability self-assessment tool\n* Intervention menu\n* Patient roadmap\n* WhatsApp coach\n* Guideline desk reference\n* Tracing job aid\n\nThe toolkit will be implemented by facility staff as part of routine care during a pilot program; the study will evaluate its implementation and outcomes.", 'armGroupLabels': ['ART clients exposed to intervention', 'ART clients seeking care at study sites', 'Providers exposed to the intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'contacts': [{'name': 'Jacqui Miot', 'role': 'CONTACT', 'email': 'jmiot@heroza.org', 'phone': '27 83 616 0008'}, {'name': 'Nyasha Mutanda', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Health Economics and Epidemiology Research Office', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'centralContacts': [{'name': 'Linda Sande', 'role': 'CONTACT', 'email': 'lsande@heroza.org', 'phone': '27 63 115 1952'}, {'name': 'Mhairi Maskew', 'role': 'CONTACT', 'email': 'mmaskew@heroza.org', 'phone': '27 82 330 9216'}], 'overallOfficials': [{'name': 'Sydney Rosen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We will post completely anonymized, coded data sets generated by the study to a public repository after all analysis and publication has been completed. Individual transcripts are too identifiable to be posted alone, even if they are deidentified. Data from medical records will not belong to the study team and will not be posted.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'HE2RO, University of the Witwatersrand', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}