Clinical trial NCT06580184: Theoretically Informed Behavioral Intervention
Official title: Theoretically Informed Behavioral Intervention to Prevent HIV-related Comorbidities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV, CVD, Metabolic Diseases
Keywords: Syndemic; HIV; CVD; HTN; Diabetes Mellitus; Cancer Virtual Reality; Sexual Minorities
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-08-30
Enrollment: 220
Sex: MALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 diverse sexual minority men ages 25 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 among diverse sexual minority men ages 25 and older living with HIV. The principal questions this study aims to address are:

1. Can engagement with the virtual environment enhance the quality of life for participants specifically in diverse sexual minority men?
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.

Eligibility criteria: Inclusion Criteria:

Self-identify as:

* a racial or ethnic minority
* non-heterosexual
* 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.

Primary outcomes:
measure: Quality of Life scale
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Diet
timeFrame: Months 1, 3, and 5
measure: Physical Activity
timeFrame: Months 1, 3, and 5
measure: Sleep Quality
timeFrame: Months 1, 3, and 5
measure: Health Care Utilization
timeFrame: Months 1, 3, and 5
measure: Sexual Health
timeFrame: Months 1, 3, and 5
measure: Smoking
timeFrame: Months 1, 3, and 5
measure: Social Support
timeFrame: Months 1, 3, and 5
measure: Coping
timeFrame: Months 1, 3, and 5
measure: LGBT Community Integration
timeFrame: Months 1, 3, and 5
Other outcomes:
Locations:
city: Orange
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: S. Raquel Ramos, PhD, MBA, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.