NCT06370780

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
23mo left

Started Feb 2024

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Feb 2024Apr 2028

Study Start

First participant enrolled

February 9, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

4.2 years

First QC Date

April 10, 2024

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Download the REMAIN App

OTHER

All participants download the app

Other: EPI LOVE

Interventions

Observational cohort only

Download the REMAIN App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Pamina Gorbach, DrPh

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamina Gorbach, DrPh

CONTACT

Valerie El-Alfi, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
N/A - all participants get the app
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 17, 2024

Study Start

February 9, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

October 3, 2025

Record last verified: 2025-09

Locations