Theoretically Informed Behavioral Intervention

Theoretically Informed Behavioral Intervention to Prevent HIV-related Comorbidities

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. Can the virtual environment improve quality of life among these participants?
2. Does the LEARN 2 platform effectively serve as prevention education for HIV comorbidity shared risk factors?

Researchers will compare participants receiving the LEARN2 virtual environment intervention to those in a waitlist control group to see if the intervention leads to improvements in quality of life and reductions in risk factors.

Participants will be asked to:

1. Engage with the virtual environment weekly.
2. Participate in virtual live health educator sessions.
3. Complete daily assessments of personal health behaviors through Ecological Momentary Assessment.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; Metabolic Disease; CVD
• Intervention / Treatment: Behavioral: LEARN 2 Platform

Detailed Description

The goal of this waitlist control clinical trial is to determine the efficacy of the tailored LEARN 2 platform in preventing HIV-related comorbidities characterized by shared risk factors. The principal questions this study aims to address are:

1. Can engagement with the virtual environment enhance the quality of life for participants?
2. Is the LEARN 2 platform effective in providing prevention education of shared risk factors associated with HIV comorbidities?

To evaluate these objectives, the investigators will conduct comparisons between participants allocated to the LEARN 2 virtual environment intervention and those assigned to a waitlist control group. This design will facilitate the assessment of whether participation in the LEARN 2 intervention correlates with significant improvements in quality of life metrics (behavioral and psychosocial) and a reduction in associated health risk factors.

Participants will be instructed to:

1. Engage with the virtual environment on a weekly basis, exploring tailored health content designed to address their specific needs.
2. Attend virtual live sessions with health educators, where they will receive real-time education on health issues relevant to their condition and associated lifestyle factors using the American Heart Association's Life's Essential 8 as a behavioral prevention framework.
3. Complete daily assessments of their personal health behaviors using Ecological Momentary Assessment (EMA), capturing real-time data on behavioral trends that may influence their health outcomes.

This systematic approach aims to generate comprehensive data on the impact of the LEARN 2 intervention on both quality of life and the modulation of health-related behaviors among these at-risk populations.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Penelope Schlesinger; Phone Number: 203 764-7573; Email: ysn.thelearn2study@yale.edu

Study Locations

• United States
  • Connecticut
    • Orange, Connecticut, United States, 06477
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Self-identify as:

• living with HIV
• English speaking
• Access to a device compatible with LEARN 2

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEARN 2 Platform; 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; 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.
Active Comparator: Waitlist Control; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet	1-item that has participants rate how healthy one's eating was that day and has been validated in EMA studies	Months 1, 3, and 5
Physical Activity	3 items that assess the number of minutes of light, moderate, and heavy physical activity and has been validated in EMA studies.	Months 1, 3, and 5
Sleep Quality	1-item that assesses the quality of sleep for the previous night from 1(poor) to 8(extremely rested) and has been validated in EMA	Months 1, 3, and 5
Health Care Utilization	assesses perceived health needs, whether they have a plan to deal with those needs, and whether they saw a health care provider about those needs	Months 1, 3, and 5
Smoking	2-items used in EMA studies that assessed whether the participant smoked and how many cigarettes	Months 1, 3, and 5
Social Support	3-item scale that assesses the among of emotional, informational, and tangible support received from their social network	Months 1, 3, and 5
Coping	7-item scale where participants rate whether they used 7 different coping strategies which has been validated in EMA studies.	Months 1, 3, and 5
Social Cohesion	7-item scale that measures decree of cohesion within a person's neighborhood or community.	Months 1, 3, and 5
Physical Relationship Health	4-items that assess whether participants were intimate and type of activity	Months 1, 3, and 5

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: S. Raquel Ramos, PhD, MBA, MSN, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; HIV; Diabetes Mellitus; Prevention; Virtual Reality; CVD; HTN; Syndemic
• Additional Relevant MeSH Terms: Endocrine System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Neoplasms; Diabetes Mellitus; Metabolic Diseases
• Other Study ID Numbers: 2000033508; R01MD019956 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No