EPI LOVE for HIV Infection

(EPI-LoVE Trial)

Overseen By Pamina Gorbach, DrPh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Virally suppressed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people living with HIV who struggle to control the virus. It focuses on understanding and addressing issues such as drug use, mental health challenges, and barriers to HIV care, including discrimination and living in rural areas. Participants will use an app designed to support long-term viral suppression. English or Spanish-speaking adults with HIV who are not currently achieving or maintaining viral suppression and face challenges like missed appointments or mental health issues may benefit. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support systems for people with HIV.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the EPI LOVE protocol is safe?

Research shows that EPI LOVE is under study to assist people with HIV who struggle to manage the virus. Although limited information exists on the safety of EPI LOVE, its testing indicates that researchers find it worth exploring.

This trial has progressed beyond its early stages, meaning initial safety checks have been completed. If EPI LOVE were unsafe, the study would not have continued. Similar digital health tools, such as app-based support, typically perform well because they do not involve medication or medical procedures.

Currently, there are no reports of serious side effects from EPI LOVE. It aims to address issues like stigma and mental health, potentially offering additional benefits without added risks. Participants should remain informed and consult their healthcare providers if they have any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the REMAIN app because it offers a novel approach to managing long-term viral suppression through technology. Unlike standard treatments for viral suppression, which typically involve medication adherence and regular medical appointments, this app provides a digital tool to support and monitor patients' health behaviors in real-time. The app's ability to predict and intervene on viral suppression electronically means it could help patients maintain their health more effectively and conveniently, potentially reducing the need for frequent in-person visits. This innovative use of technology could transform how patients manage their condition, making it easier and more accessible.

What evidence suggests that EPI LOVE might be an effective treatment for HIV?

Research has shown that EPI LOVE aims to assist people with HIV who struggle to maintain very low viral levels. In this trial, all participants will download the REMAIN App, a component of the EPI LOVE program. The program uses digital tools to support individuals by addressing issues like substance use, mental health, and access to care, which can hinder virus control. Although specific data on EPI LOVE's effectiveness is limited, similar digital programs have shown promise in improving health by providing easy-to-access support and resources. This approach is designed to address the unique challenges faced by different communities, including variations in race and location. ^{1 6 7 8 9}

Who Is on the Research Team?

Pamina Gorbach, DrPh

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

Inclusion Criteria

I am living with HIV.

I own a smartphone.

I am not currently managing my viral condition well, or I often miss appointments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Cohort Engagement

Participants engage with the REMAIN App for monitoring and data collection

48 months

Frequent app-based check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EPI LOVE

How Is the Trial Designed?

Group I: Download the REMAIN App Experimental Treatment 1 Intervention

All participants download the app

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

AIDS Healthcare Foundation

Collaborator

Trials

19

Recruited

147,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1.

barc.ph.ucla.edu

barc.ph.ucla.edu/projects/exploring-predicting-and-intervening-on-long-term-viral-suppression-electronically-epi-love/

Exploring, Predicting, and Intervening on Long-term Viral ...

EPI-LOVE will enroll a large, digitally maintained cohort of PLWH in US who are not adequately virally suppressed (>200 copies/mL) and individuals who report ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05929482

Impact of a Telenovela/Soap Opera for HIV Prevention in ...

Participants in the intervention group will receive the 4 episodes of the Love infection intervention (one episode weekly) after the baseline assessment.

3.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20855-5

Barriers and facilitators of a large clinical trial on prevention of ...

The PROMISE-EPI prevention package proved efficacious in preventing HIV transmission and was safe [7]. While demonstrating the efficacy of an ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5142082/

Impact of the Centers for Disease Control's HIV ...

Conclusions. Implementation of CDC PrEP guidelines would result in strong and sustained reductions in HIV incidence among MSM in the United ...

5.

ysph.yale.edu

ysph.yale.edu/news-article/court-ruling-on-prep-could-lead-to-more-than-2000-hiv-infections-in-the-next-year/

Court ruling on PrEP could lead to more than 2000 HIV ...

Focusing on men who have sex with men (MSM), they estimated that for every 1% decrease in the number of PrEP-eligible MSM receiving PrEP ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8665391/

Limited Interaction Targeted Epidemiology of HIV in Sexual ...

Risk criteria: (a) inconsistent condom use, (b) HIV-positive partner, and/or (c) bacterial sexually transmitted infection in the past 6 months.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02493647

Love, Sex & Choices: A Web Series on Mobile Devices to ...

This study tests a 12-episode Internet-based, guide enhanced Love, Sex, & Choices (LSC) HIV prevention soap opera video series for smartphones or computers.

8.

health.ny.gov

health.ny.gov/diseases/aids/providers/reports/scsn/docs/integrated_hiv_prevention_plan.pdf

Integrated HIV Prevention and Care Plan

New York State aims to decrease new HIV infections to 750 by the end of 2020. The plan grew from community leadership and engagement.

9.

aidsmap.com

aidsmap.com/about-hiv/female-female-sexual-transmission-hiv

Female-to-female sexual transmission of HIV

There have been only six reported cases of woman-to-woman sexual transmission, and these reports need to be viewed with the same caution as any other case ...