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NCT Number: NCT06580184

Theoretically Informed Behavioral Intervention

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.

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Key information

Conditions

HIV CVD Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Disease Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

Orange, Connecticut, 06477, United States

About this study

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:

  • Can engagement with the virtual environment enhance the quality of life for participants?
  • 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:

  • Engage with the virtual environment on a weekly basis, exploring tailored health content designed to address their specific needs.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

LEARN 2 Platform

Behavioral

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.

Primary outcomes

  1. Quality of Life scale

    Time frame: Baseline, 3 and 6 months

    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.

Secondary outcomes

  1. Diet

    Time frame: Months 1, 3, and 5

    1-item that has participants rate how healthy one's eating was that day and has been validated in EMA studies

  2. Physical Activity

    Time frame: Months 1, 3, and 5

    3 items that assess the number of minutes of light, moderate, and heavy physical activity and has been validated in EMA studies.

  3. Sleep Quality

    Time frame: Months 1, 3, and 5

    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

  4. Health Care Utilization

    Time frame: Months 1, 3, and 5

    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

  5. Physical Relationship Health

    Time frame: Months 1, 3, and 5

    4-items that assess whether participants were intimate and type of activity

  6. Smoking

    Time frame: Months 1, 3, and 5

    2-items used in EMA studies that assessed whether the participant smoked and how many cigarettes

  7. Social Support

    Time frame: Months 1, 3, and 5

    3-item scale that assesses the among of emotional, informational, and tangible support received from their social network

  8. Coping

    Time frame: Months 1, 3, and 5

    7-item scale where participants rate whether they used 7 different coping strategies which has been validated in EMA studies.

  9. Social Cohesion

    Time frame: Months 1, 3, and 5

    7-item scale that measures decree of cohesion within a person's neighborhood or community.

Study contacts

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

Penelope Schlesinger

CONTACT

[email protected]

203 764-7573

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Theoretically Informed Behavioral Intervention to Prevent HIV-related Comorbidities

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 30, 2024
Registry last updated
Jun 16, 2026

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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