Theoretically Informed Behavioral Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LEARN 2 Platform.
- Who it may be relevant to
- Registry conditions: HIV, CVD, Metabolic Disease. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Theoretically Informed Behavioral Intervention to Prevent HIV-related Comorbidities
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Quality of Life scale [Time frame: Baseline, 3 and 6 months]
Secondary outcome measures (9)
- Diet [Time frame: Months 1, 3, and 5]
- Physical Activity [Time frame: Months 1, 3, and 5]
- Sleep Quality [Time frame: Months 1, 3, and 5]
- Health Care Utilization [Time frame: Months 1, 3, and 5]
- Physical Relationship Health [Time frame: Months 1, 3, and 5]
- Smoking [Time frame: Months 1, 3, and 5]
- Social Support [Time frame: Months 1, 3, and 5]
- Coping [Time frame: Months 1, 3, and 5]
- Social Cohesion [Time frame: Months 1, 3, and 5]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Yale University — Orange
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. PMID 38924481
Identifiers
NCT: NCT06580184 · 2000033508 · R01MD019956