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Recruiting

NCT Number: NCT06370780

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

EPI LOVE

Other

Observational cohort only

Primary outcomes

  1. Incidence of HIV Viral Suppression

    Time frame: past 3 months

    Suppression defined as having less than 200 copies of HIV per milliliter of blood.

  2. Level of Adherence to HIV medication

    Time frame: past 6 months

    Adherence of at least 80% to ARV medication

  3. Level of Adherence based on HIV appointments

    Time frame: one year

    Adherence defined as not missing more than 1 HIV care appointment in 1 year

Study contacts

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

Pamina Gorbach, DrPh

CONTACT

[email protected]

(628) 226-1863

Valerie El-Alfi, MA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • AIDS Healthcare Foundation
  • Florida State University
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of California, Irvine
  • University of North Carolina, Chapel Hill

Registry information

Acronym: EPI-LoVE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 17, 2024
Registry last updated
Oct 3, 2025

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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