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Theoretically Informed Behavioral Intervention

ConditionsHIVCVDMetabolic Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

living with HIV

English speaking

Access to a device compatible with LEARN 2

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: LEARN 2 PlatformExperimental treatment 1 intervention
Group B: Waitlist ControlActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline, 3 and 6 months

Secondary outcomes

1

Diet

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

Time frame
Months 1, 3, and 5
2

Physical Activity

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

Time frame
Months 1, 3, and 5
3

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

Time frame
Months 1, 3, and 5
4

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

Time frame
Months 1, 3, and 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: