Online Platform for Men with HIV

Overseen By Study Coordinator

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Heart attack, Stroke, Cognitive impairment, Cancer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online platform called LEARN 2 to determine if it can help men living with HIV improve their quality of life and reduce risks for other health issues. Participants will engage with a virtual environment designed to educate them on preventing these health problems. The trial compares two groups: one using the LEARN 2 platform and another waiting for access. Men who have HIV, speak English, and have a compatible device might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the lives of many living with HIV.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a virtual platform to improve quality of life and does not mention medication changes.

What prior data suggests that the LEARN 2 platform is safe for participants?

Research has shown that the LEARN 2 platform educates people on preventing health issues related to HIV. As an online platform, it is generally safe to use, with no reports of physical side effects, unlike medications or medical procedures. Participants access the information through their computers or devices in this virtual environment.

The main concern is the platform's ease of use and helpfulness. One study examined people's opinions about this virtual environment. The results showed that users found it interesting and easy to use, indicating they felt comfortable and safe.

In summary, as an online tool, the LEARN 2 platform is well-tolerated with no physical risks. Users have reported it as easy and beneficial, supporting its safety as an educational tool. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LEARN 2 Platform because it offers a novel approach to health education for men with HIV. Unlike traditional methods, which might include in-person counseling or printed materials, this platform delivers education through a virtual environment. Participants can use customizable avatars, providing anonymity and comfort, which could enhance engagement. This innovative method aims to address HIV-related comorbidities by focusing on shared risk factors, potentially improving health outcomes in a more interactive and personalized way.

What evidence suggests that the LEARN 2 platform is effective for preventing HIV-related comorbidities?

Research has shown that the LEARN 2 platform, which participants in this trial may engage with, might improve quality of life and reduce health risks for people with HIV. One study found that online health education significantly increased understanding of HIV prevention and care. Another study found that virtual programs focused on preventing heart disease were popular and helpful for participants. These findings suggest that the LEARN 2 platform, which combines these methods, could assist men with HIV in managing their health more effectively. Participants in the waitlist control group will access the LEARN 2 platform after a waiting period, allowing researchers to assess the platform's efficacy. ^{1 2 6 7 8}

Who Is on the Research Team?

S. Raquel Ramos, PhD, MBA, MSN

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for sexual minority men aged 25 or older living with HIV. It aims to see if the LEARN 2 platform can prevent HIV-related comorbidities by improving quality of life and educating on risk factors. Participants must engage weekly in a virtual environment, attend live sessions, and track daily health behaviors.

Inclusion Criteria

Self-identify as non-heterosexual

English speaking

Access to a device compatible with LEARN 2

Exclusion Criteria

Medical history of serious complications such as stroke

Medical history of serious complications such as cognitive impairment

I have had a heart attack before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with the LEARN 2 virtual environment, attend virtual live sessions with health educators, and complete daily assessments of personal health behaviors.

6 months

Weekly virtual engagement and daily assessments

Follow-up

Participants are monitored for quality of life and health behavior changes after the intervention

6 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• LEARN 2 Platform

Trial Overview The study tests the LEARN 2 platform's effectiveness as an educational tool for preventing comorbidities associated with HIV. Researchers will compare outcomes between those using the intervention and a waitlist control group to assess improvements in quality of life and risk reduction.

How Is the Trial Designed?

Group I: LEARN 2 Platform Experimental Treatment 1 Intervention

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.

Group II: Waitlist Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

Out of 2408 drug reports analyzed from the online platform mijnmedicijn.nl, 3.9% reported sexual adverse events (sAEs), with a notable prevalence among antidepressants, hormonal contraceptives, and medications for benign prostatic hyperplasia.

Women reported sAEs in 3.5% of their total reports, while men reported them in 4.7%, indicating a significant gender difference in reporting, particularly for antidepressants which had high reporting odds ratios (ROR) of 4.2 for women and 7.5 for men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reporting of sexual adverse events on an online platform for medication experiences. Gordijn, R., Wessels, W., Kriek, E., et al.[2023]

In a study of people living with HIV/AIDS in Brazil, 25.7% of patients modified their antiretroviral therapy (ART) within the first year due to adverse events, with the median time to modification being 70.5 days after starting treatment.

The most common adverse events leading to ART modification were dermatological, neuropsychiatric, and gastrointestinal issues, with patients on a specific combination of zidovudine, lamivudine, and efavirenz being twice as likely to switch therapies compared to those on tenofovir with lamivudine and efavirenz.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. Azevedo, LN., Ximenes, RAA., Monteiro, P., et al.[2022]

In a study of 1301 HIV-infected participants over a median follow-up of 5 years, significant differences in the risk of specific adverse events were observed based on gender and race, with black participants showing higher risks for cardiovascular and renal events, and women having a greater risk for anemia.

Despite these differences in specific adverse events, the overall rates of adverse events, all-cause mortality, and treatment discontinuations due to toxicity were similar across gender and racial groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethnicity, race, and gender. Differences in serious adverse events among participants in an antiretroviral initiation trial: results of CPCRA 058 (FIRST Study). Tedaldi, EM., Absalon, J., Thomas, AJ., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-metabolic-diseases-8-2024-0eeb5

Online Platform for Men with HIV · Info for Participants It aims to see if the LEARN 2 platform can prevent HIV-related comorbidities by improving quality of life and educating on risk factors. Participants must ...

2. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074822003535

Cardiovascular Disease Prevention Education Using a ... Our study aims to (1) explore concerns, management, perceptions of risk, and prioritization of HIV-related comorbidities among sexual-minority men with HIV; (2) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11929354/

Integration of the national HIV curriculum in medicine ... Students across all three health disciplines reported statistically significant increases in knowledge of HIV prevention and care services and ...

4. jmir.org jmir.org/2024/1/e57351/

Perceptions of HIV-Related Comorbidities and Usability ... This study aims to explore perceptions of HIV-related comorbidities and assess the interest in and usability of a virtual environment for CVD prevention ...

5. healthhiv.org healthhiv.org/learning/

Learning – HealthHIV The HealthHIV National HIV E-Learning Training Center develops and implements e-learning training to build the knowledge, skills and competencies of HIV ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8058944/

Utilizing electronic health record data to understand ... The goal of the current study is to predict the change of non-AIDS-related comorbidity burden after HIV diagnosis using EHR data and machine learning method.

7. way2drug.com way2drug.com/hiv/

Anti-HIV Pred | Way2Drug Platform Click "Predict" button to predict whether a compound inhibits HIV molecular targets and has biological activities for HIV-associated comorbidities. Click ...

8. researchgate.net researchgate.net/publication/340149930_A_Machine_Learning_Approach_to_Understanding_HIV_and_Comorbidities_in_Electronic_Health_Record_Data

(PDF) A Machine Learning Approach to Understanding HIV ... A Machine Learning Approach to Understanding HIV and Comorbidities in Electronic Health Record Data. January 2018; SSRN Electronic Journal. DOI ...