Digital Prevention Program for HIV/STI Risk Reduction in Couples

(LuvHub Trial)

No longer recruiting at 1 trial location

Overseen By Rob Stephenson, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: Intimate partner violence, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a digital program called LuvHub helps male couples reduce their risk of HIV and sexually transmitted infections (STIs). The program focuses on aiding couples in using prevention-care strategies, creating and adhering to a prevention plan, and enhancing relationship aspects. It involves a web app with resources and modules for couples to complete together. Ideal candidates are male couples who have been in a relationship for over three months and have engaged in condomless anal sex during that time. Participants must reside in the U.S., have internet access, and feel comfortable self-administering some tests at home. As an unphased trial, this study offers a unique opportunity to contribute to innovative prevention strategies and improve both personal and community health.

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 digital health interventions and self-administered tests, so it's likely you can continue your medications, but it's best to confirm with the trial organizers.

What prior data suggests that this digital health intervention is safe for couples?

Research has shown that digital health tools like LuvHub are generally safe and easy to use. Studies indicate that digital methods for preventing HIV/STIs typically don't cause physical side effects. The LuvHub app offers resources to assist couples with HIV/STI prevention and relationship skills. No reports of negative effects have emerged from using digital platforms for sexual health education. This suggests that participants can use LuvHub without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LuvHub program because it offers a fresh, digital approach to reducing HIV and STI risks among couples. Unlike traditional prevention methods, which often rely on individual education or medication, LuvHub focuses on interactive and comprehensive web-based modules designed for couples. This digital platform aims to enhance communication and joint decision-making, promoting healthier relationship dynamics and safer practices. By using technology to engage both partners actively, LuvHub has the potential to make HIV/STI prevention more accessible and engaging, especially for tech-savvy users.

What evidence suggests that the LuvHub digital program is effective for HIV/STI risk reduction in couples?

Research shows that LuvHub, a digital program, might help couples reduce their risk of HIV and other sexually transmitted infections (STIs). It provides lessons on prevention, communication, and decision-making skills specifically for partners. In this trial, participants in the intervention arm will access the full LuvHub web app, while those in the waitlist control arm will initially have limited access before receiving the full intervention later. Studies have found that relationship-focused programs can help individuals adhere to prevention plans and enhance partner interactions. Although specific data on LuvHub's effectiveness is limited, it is designed using proven methods for preventing HIV and STIs. The goal is to enhance communication and establish agreements that lower risk and increase support between partners. ^{1 2 3 5 6}

Who Is on the Research Team?

Jason W Mitchell, PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Not have any history of intimate partner violence since relationship began

I have had unprotected anal sex in the last 3 months.

Be in a relationship with current partner for at least 3 months

Exclusion Criteria

Does not meet one or more of the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm have access to the LuvHub web app intervention and all of its contents, including post-baseline assessments every 4 months

16 months

Assessments at 4, 8, 12, and 16 months

Waitlist Control

Participants in the waitlist control condition have access to the LuvHub web app for post-baseline assessments at 4 and 8 months, and then full access from 8 to 16 months

16 months

Assessments at 4, 8, 12, and 16 months

Follow-up

Participants are monitored for changes in adherence to agreements, risk-reduction plans, and relationship dynamics

4 months

What Are the Treatments Tested in This Trial?

Interventions

• LuvHub
• Waitlist Control LuvHub

Trial Overview

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.

How Is the Trial Designed?

Group I: Waitlist Control Experimental Treatment 1 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: Intervention Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

This scoping review identified 15 unique digital health interventions (DHIs) aimed at promoting healthy romantic relationships among adolescents, developed across 11 countries, highlighting the potential for culturally tailored programming.

While some DHIs showed small positive effects on communication skills related to healthy relationships, further research is needed to establish effective outcomes and evaluation measures, as well as to explore broader social contexts influencing adolescent relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Digital Health Interventions to Promote Healthy Romantic Relationships in Adolescents. Emerson, A., Pickett, M., Moore, S., et al.[2023]

The 2GETHER intervention, which combines HIV prevention and relationship education, was well-received by 57 young male couples, with 93% reporting positive impressions and high ratings for all components.

Participants showed significant improvements in HIV risk behaviors, knowledge, motivation, and relationship investment after the intervention, suggesting that integrating relationship education with sexual health programming can effectively reduce HIV transmission risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. Newcomb, ME., Macapagal, KR., Feinstein, BA., et al.[2019]

A telehealth intervention for STI testing among partnered gay, bisexual, and other men who have sex with men (GBMSM) was highly accepted, with 92% rating the quality of telehealth calls as very good and 96% returning specimens for testing.

The intervention identified a 9% positivity rate for chlamydia or gonorrhea among participants, all of whom were successfully linked to care, suggesting that telehealth can effectively address barriers to STI testing in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of a Telehealth Intervention for STI Testing Among Male Couples. Sullivan, SP., Sullivan, PS., Stephenson, R.[2021]

The HEART digital sexual health intervention was successfully redeveloped to be more interactive and accessible, allowing for broader dissemination and customization, which is crucial for addressing HIV/STDs and unintended pregnancies among adolescents.

In a study involving 233 adolescents, the new HEART program was found to be highly acceptable and feasible, showing no differences in acceptability based on gender or sexual identity, indicating its potential for widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redeveloping a Digital Sexual Health Intervention for Adolescents to Allow for Broader Dissemination: Implications for HIV and STD Prevention. Javidi, H., Widman, L., Lipsey, N., et al.[2021]

A survey of 3,050 dating and hook-up website users, along with input from website owners and health department directors, identified key online interventions that could effectively reduce HIV and STD transmission, such as automated testing reminders and access to sexual health experts.

There was strong agreement among stakeholders on the importance of features like local STD test site directories and safer sex profile options, indicating a consensus on prioritizing these resources for online prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How can we improve online HIV and STD prevention for men who have sex with men? Perspectives of hook-up website owners, website users, and HIV/STD directors. Wohlfeiler, D., Hecht, J., Volk, J., et al.[2023]

The Men's Safer Sex (MenSS) website is being tested in a pilot trial with 166 male participants aged 16 and over, aiming to assess its feasibility in increasing condom use and reducing sexually transmitted infections (STIs) among men who have had recent unprotected sex.

The primary outcome of the trial is to measure condom use at 3 months, while STI rates will be tracked through clinic records at 12 months, providing insights into the effectiveness of this digital intervention compared to usual sexual health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men. Bailey, JV., Webster, R., Hunter, R., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC1447878/

The Efficacy of a Relationship-Based HIV/STD Prevention ...

GED = general equivalency diploma; STD = sexually transmitted disease. aSample sizes are 81, 72, and 63 for couples, woman alone, and education, respectively. b ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5870871/

Couple-Based HIV Prevention for Low-Income Drug Users ...

Long-term Effects of an HIV/STI Sexual Risk Reduction Intervention for Heterosexual Couples. Aids Behav. 2005;9:1–13. doi: 10.1007/s10461-005-1677-0. [DOI] ...

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apha.confex.com

apha.confex.com/apha/2022/meetingapp.cgi/Paper/518351

Protocol of LuvHub: A randomized controlled trial of an ...

Conclusions: LuvHub may help close the gap on the need for efficacious, couples-based HIV/STI interventions that are widely accessible and can be tailored to ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05708014

Personalized Prevention for Couples: A 16-month Digital ...

The LuvHub intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening ...

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ichgcp.net

ichgcp.net/clinical-trials-registry/NCT05708014

A 16-month Digital RCT (LuvHub) - ICH GCP

The LuvHub intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7152691/

Digital health for sexually transmitted infection and HIV ...

This study aimed to review how digital health has been used for STI/HIV prevention, testing, and treatment.