Integrated Navigation Services for Treatment Adherence, Counseling, and Research (INSTACARE)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infection Primary
• Intervention / Treatment: Behavioral: INSTACARE

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley J Gray, MPH; Phone Number: 3052431497; Email: ajg2940@miami.edu
• Study Contact Backup: Name: Sonjia Kenya, EdD; Phone Number: 3053018366; Email: skenya@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Sonjia Kenya, EdD; Phone Number: 3052438893; Email: skenya@med.miami.edu
      • Principal Investigator: Sonjia Kenya, EdD
      • Contact: Ashley Gray, MSPH; Phone Number: 305-243-1497; Email: ajg2940@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INSTACARE arm; Participants in this arm will receive the INSTACARE intervention for three months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Sonjia Kenya, EdD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: community health worker; HIV viral suppression
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 20201234; R01MD018187 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No