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

220 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment LEARN 2 Platform for men with HIV?

The research suggests that web-based patient-reported outcomes (PROs) can improve communication between patients and healthcare providers, leading to better identification and management of health issues in people with HIV. Additionally, computer-based education programs have been shown to effectively enhance understanding of HIV and its treatment, which may support the effectiveness of the LEARN 2 Platform. ^{1 2 3 4 5}

Is the Online Platform for Men with HIV generally safe for humans?

The safety data for the Online Platform for Men with HIV is not directly available, but studies on antiretroviral therapy (ART) for HIV show that adverse events like skin issues, mood changes, and stomach problems can occur. These side effects led to changes in treatment for some patients, indicating the importance of monitoring for safety. ^{6 7 8 9 10}

How is the LEARN 2 Platform treatment different from other treatments for men with HIV?

The LEARN 2 Platform is unique because it is an online platform specifically designed to provide information, support, and community engagement for men with HIV, leveraging the internet to address their needs and reduce isolation, unlike traditional medical treatments that focus solely on medication. ^{11 12 13 14 15}

What is the purpose of 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 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.

Research Team

S. Raquel Ramos, PhD, MBA, MSN

Principal Investigator

Yale University

Eligibility Criteria

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

I am living with HIV.

English speaking

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Positive Outcomes: Validity, reliability and responsiveness of a novel person-centred outcome measure for people with HIV. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Computer-Based HIV Education Program for Adults Living with HIV. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Utility and Impact of the Implementation of Same-Day, Self-administered Electronic Patient-Reported Outcomes Assessments in Routine HIV Care in two North American Clinics. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

PRO-Act: a healthcare provider workshop outlining the added value of implementing PROs in routine HIV practice. [2023]

6. Brazil pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. [2022]

7. United States 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). [2022]

8. England pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Patient reporting of sexual adverse events on an online platform for medication experiences. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse events from drug therapy for human immunodeficiency virus disease. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Perceptions of HIV-related websites among persons recently diagnosed with HIV. [2021]

12. Spain pubmed.ncbi.nlm.nih.gov

[Attitudes toward online HIV/sexually-transmitted infection prevention programs and Internet user profiles among men who have sex with men]. [2018]

13. France pubmed.ncbi.nlm.nih.gov

[Not Available]. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

A pilot intervention utilizing Internet chat rooms to prevent HIV risk behaviors among men who have sex with men. [2022]