Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT04663152

Conditions

HIV Infection Primary

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INSTACARE

Study Details

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.

Conditions

HIV Infection Primary

Study ID

NCT04663152

Start date

Jul 26, 2023

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: INSTACARE arm

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

Interventions

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.

Primary outcome measure

  • Communication Preferences [ Time Frame: 3 months ]
  • Number of CHW contacts [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Ashley J Gray, MPH

3052431497ajg2940@miami.edu

Sonjia Kenya, EdD

3053018366skenya@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Ashley Gray, MSPH

305-243-1497ajg2940@miami.edu

Sonjia Kenya, EdD

3052438893skenya@med.miami.edu

Principal Investigator:

Sonjia Kenya, EdD

More Information

Sponsor

University of Miami

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • HIV viral suppression
  • community health worker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-06-29.