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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HL145580-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The investigator is testing a virtual environment to address prevention of HIV-related comorbidities.
The primary aims of this study are to test the feasibility, acceptability and preliminary effects of a VE to address prevention of HIV-related comorbidities. A waitlist control feasibility clinical trial will be conducted. We will assign (N=80) eligible participants and ensure balanced allocation to intervention and control groups over the intervention period. We hypothesize that the VE will be feasible and acceptable to persons living with HIV, and that they will apply their VE learning to real-life situations and health behaviors for prevention of HIV-related comorbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention Group | Experimental | Participants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions. |
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| Waitlist Control Group | Other | Participants will enter an online game at a later date after the immediate intervention group and learn about how to prevent cardiovascular and metabolic conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gaming in a virtual environment | Behavioral | To address the primary outcomes of feasibility and acceptability of the VE, we will capture process data using a computer-based virtual environment and self-report measures using an online survey. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability/Feasibility {change over 3 timepoints} | Based on Technology Acceptance Model, using the same unit of measure, we will examine Perceived Usefulness (Cronbach's alpha 0.98) and Perceived Ease of Use (Cronbach's alpha 0.94) with an online 7-point Likert scale. | Baseline and Month 3 & 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular health {change over 3 timepoints} | Life's Simple 7, based on 7 modifiable health behaviors, provides scores (range, 0 to 14) based on smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and fasting glucose. This study will only measure 4 out of the 7: smoking, diet, physical activity, and BMI. | Baseline and Month 3 & 6 |
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Inclusion Criteria:
Exclusion Criteria:
Anything outside of inclusion parameters, including history of:
assigned male sex at birth
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| Name | Affiliation | Role |
|---|---|---|
| S. Raquel Ramos, PhD, MBA, MSN, FNP-BC | Yale University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Orange | Connecticut | 06477 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31343963 | Background | Ramos SR, Warren R, Shedlin M, Melkus G, Kershaw T, Vorderstrasse A. A Framework for Using eHealth Interventions to Overcome Medical Mistrust Among Sexual Minority Men of Color Living with Chronic Conditions. Behav Med. 2019 Apr-Jun;45(2):166-176. doi: 10.1080/08964289.2019.1570074. | |
| 33481464 | Background | Ramos SR, O'Hare OM, Hernandez Colon A, Kaplan Jacobs S, Campbell B, Kershaw T, Vorderstrasse A, Reynolds HR. Purely Behavioral: A Scoping Review of Nonpharmacological Behavioral and Lifestyle Interventions to Prevent Cardiovascular Disease in Persons Living With HIV. J Assoc Nurses AIDS Care. 2021 Sep-Oct 01;32(5):536-547. doi: 10.1097/JNC.0000000000000230. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 30, 2026 | |
| Reset | Apr 21, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2026 | Apr 21, 2026 | |||
| Jun 15, 2026 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003075 | Coitus |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
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| Physical Activity {change over 3 timepoints} | International Physical Activity Questionnaire - Short Form will assess intensity of physical activity and sitting time using a 7-item, open-ended measure. Cronbach's alpha 0.80. | Baseline and Month 3 & 6 |
| Tobacco and E-cigarette use {change over 3 timepoints} | BRFSS - self report measure questions that pertain to Tobacco use and E-cigarette use (7 questions). kappa statistic 0.81-0.92. | Baseline and Month 3 & 6 |
| Food consumption {change over 3 timepoints} | Food Frequency Questionnaire - Reports how frequently individuals consume foods in 16 categories. Multifactor Screener has demonstrated correlations of 0.5-0.8 with estimated true intake. | Baseline and Month 3 & 6 |
| Psychosocial wellbeing {change over 3 timepoints} | Patient Health Questionnaire-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. | Baseline and Month 3 & 6 |
| Illness Perceptions {change over 3 timepoints} | The Revised Illness Perception Questionnaire measures illness perceptions about hypertension and type 2 diabetes on a 5-point Likert scale ("strongly disagree" to "strongly agree"). | Baseline and Month 3 & 6 |
| 35579928 | Background | Ramos SR, Johnson C, Melkus G, Kershaw T, Gwadz M, Reynolds H, Vorderstrasse A. Cardiovascular Disease Prevention Education Using a Virtual Environment in Sexual-Minority Men of Color With HIV: Protocol for a Sequential, Mixed Method, Waitlist Randomized Controlled Trial. JMIR Res Protoc. 2022 May 17;11(5):e38348. doi: 10.2196/38348. |
| 38924481 | Result | 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. |
| 42154285 | Derived | Ramos SR, Boerger L, Restar AJ, Phadke M, Jeon S, Johnson C, Melkus G, Kershaw T, Reynolds H, Vorderstrasse A. A Web-Based Virtual Environment Behavioral Intervention as Cardiovascular Disease and Metabolic Disease Prevention Education in Persons With HIV: Evaluation of the LEARN Randomized Controlled Trial. J Med Internet Res. 2026 Jun 15;28:e91145. doi: 10.2196/91145. |
| D007239 |
| Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |