Digital Prevention Program for HIV/STI Risk Reduction in Couples

(LuvHub Trial)

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

750 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment LuvHub for reducing HIV/STI risk in couples?

Research shows that couple-based interventions can effectively reduce HIV/STI risks, even among couples facing challenges like intimate partner violence. Additionally, digital interventions have been found to be acceptable and feasible for promoting safer sex practices, such as increased condom use and STI testing, which suggests that LuvHub could be effective in similar ways. ^{1 2 3 4 5}

Is the Digital Prevention Program for HIV/STI Risk Reduction in Couples safe for humans?

The research articles provided do not contain specific safety data for the Digital Prevention Program for HIV/STI Risk Reduction in Couples or its related interventions like LuvHub. However, one study on a telehealth intervention for STI testing among male couples reported high acceptability and successful linkage to care, suggesting it was well-received and safe in practice. ^{1 2 3 4 6}

How is the treatment LuvHub unique compared to other treatments for HIV/STI prevention?

LuvHub is unique because it is a digital prevention program designed specifically for couples, offering personalized and private support for behavior change to reduce HIV/STI risk, unlike traditional face-to-face interventions that can be resource-intensive and less tailored. ^{1 4 7 8 9}

Research Team

Jason W Mitchell, PhD

Principal Investigator

Florida International University

Eligibility Criteria

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

Has own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer)

I am in a committed relationship, recognized by both of us.

Exclusion Criteria

Does not meet one or more of the inclusion criteria

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

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

Predictors of discordant reports of sexual and HIV/sexually transmitted infection risk behaviors among heterosexual couples. [2019]

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

Acceptability and Feasibility of a Telehealth Intervention for STI Testing Among Male Couples. [2021]

3. United States 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. [2023]

4. England 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. [2022]

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

Moderation Analysis of a couple-based HIV/STI Intervention Among Heterosexual Couples in the Criminal Legal System Experiencing Intimate Partner Violence: Results from a Randomized Controlled Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

How can we objectively categorise partnership type? A novel classification of population survey data to inform epidemiological research and clinical practice. [2022]

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

A Scoping Review of Digital Health Interventions to Promote Healthy Romantic Relationships in Adolescents. [2023]

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

Redeveloping a Digital Sexual Health Intervention for Adolescents to Allow for Broader Dissemination: Implications for HIV and STD Prevention. [2021]

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

Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. [2019]