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

Primary Purpose

HIV Infection Primary

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

INSTACARE

About this trial

This is an interventional supportive care trial for HIV Infection Primary focused on measuring HIV viral suppression, community health worker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of MiamiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INSTACARE arm

Arm Description

Participants in this arm will receive the INSTACARE intervention for three months.

Outcomes

Primary Outcome Measures

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.

Number of CHW contacts

CHW contacts with participants will be extracted from CHW tracking logs.

Secondary Outcome Measures

Full Information

NCT ID

NCT04663152

First Posted

December 3, 2020

Last Updated

August 16, 2023

Sponsor

University of Miami

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT04663152

Brief Title

Integrated Navigation Services for Treatment Adherence, Counseling, and Research

Acronym

INSTACARE

Official Title

Integrated Navigation Services for Treatment Adherence, Counseling, and Research

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 26, 2023 (Actual)

Primary Completion Date

January 31, 2027 (Anticipated)

Study Completion Date

May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection Primary

Keywords

HIV viral suppression, community health worker

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

INSTACARE arm

Arm Type

Experimental

Arm Description

Participants in this arm will receive the INSTACARE intervention for three months.

Intervention Type

Behavioral

Intervention Name(s)

INSTACARE

Intervention Description

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 Measure Information:

Title

Communication Preferences

Description

Time Frame

3 months

Title

Number of CHW contacts

Description

CHW contacts with participants will be extracted from CHW tracking logs.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

BreAnne J Young, MSPH

Phone

3052435505

b.young4@umiami.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sonjia Kenya, EdD

Phone

3052435505

skenya@med.miami.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sonjia Kenya, EdD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

BreAnne Young, MSPH

Phone

305-243-8893

b.young4@umiami.edu

First Name & Middle Initial & Last Name & Degree

Sonjia Kenya, EdD

Phone

3052438893

skenya@med.miami.edu

First Name & Middle Initial & Last Name & Degree

Sonjia Kenya, EdD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Integrated Navigation Services for Treatment Adherence, Counseling, and Research

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