What side effects are associated with this type of intervention?

Common side effects of antiretroviral therapy (ART) for HIV/AIDS include nausea, vomiting, diarrhea, fatigue, and headache. Long-term use may lead to more serious issues such as liver damage, kidney problems, cardiovascular issues, and bone density loss. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for HIV/AIDS, including combination antiretroviral therapies (ART) that often involve multiple drugs to inhibit the virus's replication. Notable classes of these drugs include CCR5 inhibitors, fusion inhibitors, and non-nucleoside reverse transcriptase inhibitors. These treatments are designed to reduce viral load, improve immune function, and prevent the progression to AIDS. The webapp-based couples HIV/STI prevention intervention aligns with these strategies by promoting the uptake of ART and tailored prevention plans to reduce HIV risk among serodiscordant couples.

What other types of research exist?

Promising, novel alternatives to webapp-based couples HIV/STI prevention interventions for HIV/AIDS patients in 2024 include: 1) Dyadic behavioral interventions that focus on relationship-oriented theory to improve treatment adherence and engagement among same-sex male couples. 2) Technology-enhanced CBT-based interventions, such as online modules or smartphone applications, which have shown efficacy in promoting abstinence and improving treatment outcomes. 3) Behavioral family counseling or behavioral couples therapy, which leverage behavioral principles to reinforce abstinence and involve family members or partners in the treatment process.

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Couples-Based HIV Prevention Intervention for HIV/AIDS

N/A

Waitlist Available

Research Sponsored by Florida International University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported that currently self-identifies as a male

Self-reported in a sexual relationship with another self-identified male

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 4

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a smartphone app that helps male couples in new relationships create personalized plans to prevent HIV and STIs. The app improves communication, teaches prevention strategies, provides information on HIV/STI statistics, and addresses stigma. It also helps users find local sexual health resources.

Who is the study for?

This trial is for male couples in the U.S. who have been together for 1-12 months, had anal sex recently, can read English, and use an internet-connected device. It's not open to those who don't fit these criteria.

What is being tested?

The 'Our Plan' webapp intervention aims to reduce HIV risk among new male couples by promoting evidence-based prevention strategies through a tailored plan. The study will track how usage affects outcomes over time.

What are the potential side effects?

Since this is a behavioral intervention involving information and planning without medical drugs or procedures, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I currently identify as male.

Select...

I am in a sexual relationship with another man.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in confidence about using evidence-based prevention strategies over time by comparing baseline response to month 4 response

Change in creation of a detailed risk-reduction plan by comparing baseline response to month 4 response

Change in intention to use evidence-based prevention strategies over time by comparing baseline response to month 4 response

+2 more

Secondary study objectives

Change in goal congruence on sexual health by comparing baseline response to month 4 response

Change in mutual constructive communication by comparing baseline response to month 4 response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

From baseline to 4-month post-test, participants in the intervention arm will have access to the Our Plan web app program.

Group II: Informational controlExperimental Treatment1 Intervention

From baseline to 4-month post-test, participants in the informational control arm will not have access to the Our Plan web app program. Participants will instead receive a webpage with information about HIV/STI prevention options and resources to represent the current equivalent of a standard of care for online HIV resources.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intervention Our Plan

2022

N/A

~220

Internation Informational Control

2022

N/A

~220

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HIV/AIDS involve antiretroviral therapy (ART), which uses a combination of drugs to target different stages of the HIV life cycle. These include reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, and entry inhibitors. These drugs work together to prevent the virus from replicating, maturing, and integrating into the host's genome. For HIV/AIDS patients, effective ART is essential as it reduces viral load, improves immune function, and lowers the risk of transmission. This is particularly important in interventions like the Webapp-based Couples HIV/STI Prevention Intervention, which aims to promote evidence-based strategies and tailored prevention plans to manage and reduce HIV risk.

Online Intervention as Strategy to Reach Men Who Have Sex With Other Men and Who Use Substances in a Sexual Context. Development of the MONBUZZ.ca Project.Addressing HIV knowledge, risk reduction, social support, and patient involvement using SMS: results of a proof-of-concept study.Couple-based HIV prevention in the United States: advantages, gaps, and future directions.