NCT04663152 · University of Miami
Integrated Navigation Services for Treatment Adherence, Counseling, and Research
(INSTACARE)
What this study is about
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.
View original scientific description
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
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.
Number of CHW contacts
Time frame: 3 months
CHW contacts with participants will be extracted from CHW tracking logs.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Miami, Florida
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations