Integrated Navigation Services for Treatment Adherence, Counseling, and Research

Not Applicable

Recruiting

• Conditions: HIV Infection Primary

• Registration Number: NCT04663152
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Study Start: 2023-07-26
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2027-01-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Communication Preferences	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	3 months	CHW contacts with participants will be extracted from CHW tracking logs.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States