Integrated Navigation Services for Treatment Adherence, Counseling, and Research

HIV Infection Primary Clinical Trial

— INSTACARE  

Official title:

Integrated Navigation Services for Treatment Adherence, Counseling, and Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663152
• Other study ID #: 20201234
• Secondary ID: R01MD018187
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: BreAnne J Young, MSPH
• Phone: 3052435505
• Email: b.young4[@]umiami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ages 18 years or older
• patient from adult HIV outpatient clinic at University of Miami/Jackson Memorial Health System
• self-identify as Black
• uncontrolled viral suppression as determined by treating clinician
• English speaking

Exclusion Criteria:

• Any other condition(s) that the treating clinician determines would limit participant from meaningful study participation.

Related Conditions & MeSH terms

• HIV Infection Primary
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of CHW contacts	CHW contacts with participants will be extracted from CHW tracking logs.	3 months