NCT06580184

Brief Summary

The goal of this waitlist control clinical trial is to learn if the tailored LEARN 2 platform can prevent HIV-related comorbidities with shared risk factors in men ages 18 and older living with HIV. The main question\[s\] are:

  1. 1.Can the virtual environment improve quality of life among these participants?
  2. 2.Does the LEARN 2 platform effectively serve as prevention education for HIV comorbidity shared risk factors?
  3. 3.Engage with the virtual environment weekly.
  4. 4.Participate in virtual live health educator sessions.
  5. 5.Complete daily assessments of personal health behaviors through Ecological Momentary Assessment.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
164

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
36mo left

Started Mar 2026

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress4%
Mar 2026Mar 2029

First Submitted

Initial submission to the registry

August 29, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

August 29, 2024

Last Update Submit

February 16, 2026

Conditions

HIVCVDMetabolic Disease

Keywords

SyndemicHIVCVDHTNDiabetes MellitusCancerVirtual RealityPrevention

Outcome Measures

Primary Outcomes (1)

  • Quality of Life scale

    29-item scale from the PROMIS® Profile 29 for adults. The quality- of-life questions include physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain intensity over the past 7 days. Each question, except for the pain intensity question, is measured on a 5-point scale.

    Baseline, 3 and 6 months

Secondary Outcomes (9)

  • Diet

    Months 1, 3, and 5

  • Physical Activity

    Months 1, 3, and 5

  • Sleep Quality

    Months 1, 3, and 5

  • Health Care Utilization

    Months 1, 3, and 5

  • Physical Relationship Health

    Months 1, 3, and 5

  • +4 more secondary outcomes

Study Arms (2)

LEARN 2 Platform

EXPERIMENTAL

The intervention arm in this study involves participants engaging with the LEARN2 virtual environment, designed to provide tailored prevention education for HIV-related comorbidities with shared risk factors. Participants will navigate a virtual platform focused on health education related to body systems, utilizing customizable avatars for anonymity and comfort.

Behavioral: LEARN 2 Platform

Waitlist Control

ACTIVE COMPARATOR

The waitlist control group will not have immediate access to the LEARN2 intervention but will receive a welcome packet with information on how to contact the study team and the date they will gain access to the intervention after a waiting period. This design helps to ensure that all participants eventually receive the intervention while allowing researchers to assess the efficacy of the LEARN2 platform.

Behavioral: LEARN 2 Platform

Interventions

LEARN 2 PlatformBEHAVIORAL

The LEARN 2 Platform will provide tailored prevention education of HIV-comorbidities with shared risk factors. Participants will navigate LEARN 2 and access targeted health content.

LEARN 2 PlatformWaitlist Control

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identify as:
  • living with HIV
  • English speaking
  • Access to a device compatible with LEARN 2

You may not qualify if:

  • \- medical history of serious complications such as heart attack, stroke, cognitive impairment, or cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

Orange, Connecticut, 06477, United States

Location

Related Publications (1)

  • Ramos SR, Reynolds H, Johnson C, Melkus G, Kershaw T, Thayer JF, Vorderstrasse A. Perceptions of HIV-Related Comorbidities and Usability of a Virtual Environment for Cardiovascular Disease Prevention Education in Sexual Minority Men With HIV: Formative Phases of a Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Aug 22;26:e57351. doi: 10.2196/57351.

    PMID: 38924481BACKGROUND

MeSH Terms

Conditions

Metabolic DiseasesDiabetes MellitusNeoplasms

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • S. Raquel Ramos, PhD, MBA, MSN

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Penelope Schlesinger

CONTACT

203 764-7573ysn.thelearn2study@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2024

First Posted

August 30, 2024

Study Start

March 30, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)