Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically (EPI-LoVE)

Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: EPI LOVE

Detailed Description

This study will follow a digital cohort via the REMAIN App. The REMAIN App is adapted from the HealthMPowerment (HMP) platform and tailored to our focus population's unique needs. Digital cohorts, or eCohorts, utilize the flexibility and capacity of the internet to complement traditional approaches to epidemiological research, helping address some of the limitations and challenges associated with conventional cohort studies.

Aim 1 of this study is to recruit and retain a geographically and demographically diverse cohort of PLWH who are sub optimally engaged in care and with a history of, at high risk for, or not currently virally suppressed. Outcomes for this are levels of recruitment and retention to hit the study objectives to enroll 1,000 PLWH at risk for or experiencing VNS and follow them for up to 48 months. Aim 2 is to evaluate longitudinal patterns of care engagement within the cohort by modeling and advanced epidemiologic methods utilizing remote collection of biomarkers of HIV disease (e.g., viral load), online surveys, and brief, frequent app-based "check-ins". Outcomes include both those related to VS and engagement in care as well as engagement in the digital cohort.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valerie El-Alfi, MA; Email: RemainApp@ph.ucla.edu
• Study Contact Backup: Name: Pamina Gorbach, DrPh; Phone Number: (628) 226-1863; Email: RemainApp@ph.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
      • Contact: Valerie El-Alfi, MA; Email: RemainApp@ph.ucla.edu
      • Contact: Pamina Gorbach, DrPh, MHS; Phone Number: (628) 226-1863; Email: RemainApp@ph.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

Self-identified adults living with HIV who are over age 18.

Description

Inclusion Criteria:

• Have access to a personal smartphone device;
• Over 18 years of age;
• Speak English or Spanish;
• Living with HIV
• Are either 1) not currently virally suppressed, 2) not currently engaged in care, or 3) have one or more factors associated with viral non suppression including a history of missed appointments or viral non suppression;
• Active substance use or mental health disorder;
• Willing and able to provide written informed consent to take part in the study.

Exclusion Criteria:

• Unwilling or unable to provide reliable contact information;
• Unwilling to provide blood sample for HIV virology testing;
• Living with HIV and virally suppressed and not at risk of becoming unsuppressed in the near future.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Download the REMAIN App; All participants download the app	Other: EPI LOVE; Observational cohort only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of HIV Viral Suppression	Suppression defined as having less than 200 copies of HIV per milliliter of blood.	past 3 months
Level of Adherence to HIV medication	Adherence of at least 80% to ARV medication	past 6 months
Level of Adherence based on HIV appointments	Adherence defined as not missing more than 1 HIV care appointment in 1 year	one year

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of North Carolina, Chapel Hill; University of California, Irvine; Florida State University; AIDS Healthcare Foundation
• Investigators: Principal Investigator: Pamina Gorbach, DrPh, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 23-000477; 5UG3AI176592-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No