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Recruiting

NCT Number: NCT04663152

Integrated Navigation Services for Treatment Adherence, Counseling, and Research

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.

Recruiting

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Key information

Conditions

HIV Infection Primary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INSTACARE

Behavioral

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 outcomes

  1. 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.

  2. Number of CHW contacts

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley J Gray, MPH

CONTACT

[email protected]

3052431497

Sonjia Kenya, EdD

CONTACT

[email protected]

3053018366

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: INSTACARE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2020
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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