Integrated Navigation Services for Treatment Adherence, Counseling, and Research
INSTACARE
2 other identifiers
interventional
10
1 country
1
Brief Summary
The goal of this research is to determine whether a Community Health Worker (CHW) intervention including a mobile telehealth (M-Health) component can help achieve long term viral suppression among Black people with poorly controlled HIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
July 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
June 25, 2025
June 1, 2025
3.5 years
December 3, 2020
June 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Communication Preferences
Communication preferences will be reported as the number of participants who prefer any of the following intervention modes of administration: text messaging, phone calls, home visits, accompaniment to clinic visits, utilization of existing health portals and phone applications. Data will be collected via survey administered to participants by CHW.
3 months
Number of CHW contacts
CHW contacts with participants will be extracted from CHW tracking logs.
3 months
Study Arms (1)
INSTACARE arm
EXPERIMENTALParticipants in this arm will receive the INSTACARE intervention for three months.
Interventions
CHWs will provide participants with support via phone calls, home-visits, and accompaniment to clinic visits to improve medication management and HIV viral suppression. CHWs will contact participants at least once per week for three months.
Eligibility Criteria
You may qualify if:
- Ages 18 years or older
- Miami-Dade Resident at time of enrollment
- self-identify as Black
- Viral load \> 200 mL within the last 6-months (VL must be verified via electronic medical record or lab report prior to enrollment)
You may not qualify if:
- Any other condition(s) that the treating clinician determines would limit participant from meaningful study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
Related Publications (1)
Kenya S, Young B, Escarfuller S, Jones-Weiss D, Carrasquillo O, Riccio A, Yue P. Improving HIV outcomes in Miami's Black populations with clinic-based community health workers protocol: The integrated navigation and support for treatment adherence, counseling, and research (INSTACARE) randomized controlled trial. PLoS One. 2025 Apr 7;20(4):e0316300. doi: 10.1371/journal.pone.0316300. eCollection 2025.
PMID: 40193336DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sonjia Kenya, EdD
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 3, 2020
First Posted
December 10, 2020
Study Start
July 26, 2023
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share