What is the mechanism of action of this treatment?

Common treatments for HIV infection, primarily antiretroviral therapy (ART), work by targeting various stages of the HIV life cycle. Reverse transcriptase inhibitors prevent the virus from converting its RNA into DNA, protease inhibitors block the virus from maturing and replicating, and integrase inhibitors stop the virus from integrating its DNA into the host's genome. These mechanisms are crucial for reducing the viral load, improving immune function, and preventing disease progression. Additionally, behavioral modification and relationship management, as studied in the Digital Health Intervention trial, are essential for ensuring adherence to ART and reducing risky behaviors, thereby enhancing overall treatment efficacy and quality of life for HIV patients.

What side effects are associated with this type of intervention?

Common treatments for HIV, primarily antiretroviral therapy (ART), are associated with several side effects. These include gastrointestinal issues like nausea and diarrhea, metabolic complications such as lipodystrophy and insulin resistance, cardiovascular problems, liver toxicity, and neuropsychiatric effects including depression and anxiety. Managing these side effects is essential for maintaining adherence to ART, which is critical for the success of behavioral modification and relationship management interventions in HIV care.

What prior FDA approvals exist?

The FDA has approved several antiretroviral therapies (ART) for the treatment of HIV, including single-tablet regimens and combination therapies. Notable approvals include darunavir/cobicistat/emtricitabine/tenofovir alafenamide, which is effective for both treatment-naïve and treatment-experienced patients. Other significant combinations include bictegravir/emtricitabine/tenofovir alafenamide and dolutegravir/abacavir/lamivudine. These treatments aim to simplify adherence and improve outcomes, aligning with the goals of the Digital Health Intervention trial that focuses on behavioral modification and relationship management.

What other types of research exist?

Promising, novel alternatives to Digital Health Interventions for HIV patients in 2024 include: 1) Enhanced mobile apps integrating real-time monitoring and personalized feedback, 2) Advanced text messaging systems with AI-driven support, 3) Cognitive-behavioral therapy (CBT) delivered via telehealth platforms, 4) Contingency management programs using digital incentives, and 5) Integrated care models combining psychosocial support with digital tools for comprehensive treatment adherence.

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Behavioral Intervention

Digital Prevention Program for HIV/STI Risk Reduction in Couples (LuvHub Trial)

N/A

Waitlist Available

Led By Rob Stephenson, PhD

Research Sponsored by Florida International University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 8-months, 8-months to 16-months, baseline to 16-months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online program for male couples at risk of HIV/STI. It aims to help them follow prevention strategies, improve their relationship, and adhere to medical advice. The program encourages behavior changes through relationship-focused strategies.

Who is the study for?

This trial is for male couples in the U.S. who've been together for at least 3 months, are over 18, have had unprotected sex recently, and can use a web-connected device. They should not feel coerced to participate and must not have a history of intimate partner violence.

What is being tested?

The study tests 'LuvHub', a digital health intervention aimed at improving HIV/STI prevention-care strategies among male couples. One group uses LuvHub immediately while another waits (Waitlist Control) before accessing it.

What are the potential side effects?

Since this is a digital intervention focusing on education and behavior change rather than medication or medical procedures, traditional physical side effects are not expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 8-months, 8-months to 16-months, baseline to 16-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 8-months, 8-months to 16-months, baseline to 16-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8-months, 8-months to 16-months, baseline to 16-months 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 HIV incidence by comparing results from test kits received at baseline to 16-months.

Change in STI incidence by comparing results from test kits received at baseline to 16-months.

Changes in adherence to agreement by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.

+9 more

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: Waitlist ControlExperimental Treatment1 Intervention

From baseline to 8-months, participants in the waitlist control condition will have access to the LuvHub web app for post-baseline assessments of 4 and 8 months, and the resources section. From 8-months to 16-months, participants randomized to the waitlist control arm will then have access to the LuvHub web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur every 4 months (12 \& 16-months).

Group II: InterventionExperimental Treatment1 Intervention

From baseline to 16-months, participants randomized to the intervention arm will have access to the LuvHub web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur every 4 months (4, 8, 12, \& 16-months).

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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

Common treatments for HIV infection, primarily antiretroviral therapy (ART), work by targeting various stages of the HIV life cycle. Reverse transcriptase inhibitors prevent the virus from converting its RNA into DNA, protease inhibitors block the virus from maturing and replicating, and integrase inhibitors stop the virus from integrating its DNA into the host's genome. These mechanisms are crucial for reducing the viral load, improving immune function, and preventing disease progression. Additionally, behavioral modification and relationship management, as studied in the Digital Health Intervention trial, are essential for ensuring adherence to ART and reducing risky behaviors, thereby enhancing overall treatment efficacy and quality of life for HIV patients.