Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically

NCT ID: NCT06370780

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-09
• Study Completion Date: 2028-04-30

Brief Summary

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.

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Download the REMAIN App

All participants download the app

Group Type: OTHER

EPI LOVE

Intervention Type: OTHER

Observational cohort only

Interventions

EPI LOVE

Observational cohort only

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida State University

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

AIDS Healthcare Foundation

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Pamina Mae Gorbach

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamina Gorbach, DrPh

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pamina Gorbach, DrPh

Role: CONTACT

RemainApp@ph.ucla.edu

(628) 226-1863

Valerie El-Alfi, MA

Role: CONTACT

RemainApp@ph.ucla.edu

Facility Contacts

Pamina Gorbach, DrPh, MHS

Role: primary

RemainApp@ph.ucla.edu

(628) 226-1863

Valerie El-Alfi, MA

Role: backup

RemainApp@ph.ucla.edu

Other Identifiers

5UG3AI176592-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-000477

Identifier Type: -

Identifier Source: org_study_id