Recruiting NCT04663152
Integrated Navigation Services for Treatment Adherence, Counseling, and Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INSTACARE.
- Who it may be relevant to
- Registry conditions: HIV Infection Primary. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral INSTACARE
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.
Primary outcome measures
- Communication Preferences [Time frame: 3 months]
- Number of CHW contacts [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Any other condition(s) that the treating clinician determines would limit participant from meaningful study participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Miami — Miami
Publications
- 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 2 PMID 40193336
Identifiers
NCT: NCT04663152 · 20201234 · R01MD018187