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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD019956 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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:
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:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEARN 2 Platform | Experimental | 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. |
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| Waitlist Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Self-identify as:
Exclusion Criteria:
- medical history of serious complications such as heart attack, stroke, cognitive impairment, or cancer.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Penelope Schlesinger | Contact | 203 764-7573 | ysn.thelearn2study@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| S. Raquel Ramos, PhD, MBA, MSN | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Orange | Connecticut | 06477 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38924481 | Background | 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. |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
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| 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 |
| Physical Relationship Health | 4-items that assess whether participants were intimate and type of activity | 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 |