Mobile App for HIV Prevention

(CombineApp Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jeb Jones, PhD

Age: 18 - 65

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Emory University

Disqualifiers: Unable to provide consent

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different implementation strategies on intervention maintenance among GBMSM in rural southern United States. The main aims of the study are: * To assess the relative effects of three treatment conditions on gains in engagement in HIV prevention compared to a modified standard of care control condition * Measure and assess secondary factors affecting app implementation * Refine implementation strategies and coordinate with potential funders Participants will download an HIV prevention smartphone app and be randomly assigned to one of four groups: * Control: App access only * Self-testing: App access + ability to order HIV and STI self-test kits * Motivational interview: App access + motivational interview to develop plans to use app effectively. * Self-testing + motivational interview: App access + ability to order HIV and STI self-test kits + motivational interview to develop plans to use app effectively. Researchers will compare each of the latter three groups to the control condition to see if HIV and STI testing increase in these groups

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not be currently using PrEP (a medication to prevent HIV).

What data supports the effectiveness of the treatment Combine mobile app for HIV prevention?

Research shows that mobile apps like HealthMindr and SMARTtest have been effective in increasing HIV prevention measures, such as self-testing and pre-exposure prophylaxis (PrEP) uptake, among men who have sex with men. These apps are user-friendly and help people correctly perform tests, understand results, and connect with healthcare services. ^{1 2 3 4 5}

Is the mobile app for HIV prevention safe for humans?

The available research on mobile apps for HIV prevention, such as HealthMindr and SMARTtest, indicates that they are generally acceptable and well-received by users, with no specific safety concerns reported in the studies. ^{3 4 5 6 7}

How is the 'Mobile App for HIV Prevention' treatment different from other HIV prevention treatments?

This treatment is unique because it uses a mobile app to increase HIV prevention efforts, specifically targeting men who have sex with men (MSM) by integrating HIV/STI testing and motivational interviewing. Unlike traditional methods, it offers a comprehensive prevention plan and links users to additional resources, aiming to increase the uptake of pre-exposure prophylaxis (PrEP) and regular testing. ^{4 5 6 8 9}

Research Team

Jeb Jones, PhD

Principal Investigator

Rollins School of Public Health

Eligibility Criteria

This trial is for men aged 18-34 who have had anal sex with another man in the past year, live in rural areas of the U.S. South or Missouri, and are not currently on PrEP. They must be HIV-negative or unsure of their status, own a smartphone with service, speak English, and be willing to use a study app.

Inclusion Criteria

I have had anal sex with a man in the last year.

I am not currently taking medication to prevent HIV.

Reside in a county classified as rural using the Index of Relative Rurality

Exclusion Criteria

I am unable to give my consent.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Combine app with various features to increase HIV and STI testing and PrEP initiation

24 months

Online surveys at Screening, Month 6, Month 12, Month 18, Month 24

Follow-up

Participants are monitored for the uptake of HIV and STI testing and PrEP initiation

24 months

Treatment Details

Interventions

• Combine mobile app (Procedure)
• HIV/STI testing (Procedure)
• Motivational interview (Behavioural Intervention)

Trial Overview The trial tests if a mobile app called Combine can boost HIV/STI testing and start using PrEP among rural men who have sex with men over two years. Participants will download the app and randomly join one of four groups: control (app only), self-testing (app + test kits), motivational interview (app + planning support), or both self-testing and interview.

Participant Groups

Group I: Combine app with all features except the ability to order self-test kits Experimental Treatment 1 Intervention

Participants will receive a modified standard of care which consists of the Combine app with all features except the ability to order self-test kits. The HIV/STI testing locator in the app will be available.

Group II: Combine app + motivational interview + ability to order HIV/STI test kits via the app Experimental Treatment 3 Interventions

In addition to the other Combine app features, participants in this arm will receive both the motivational interview and the ability to order HIV/STI test kits via the app.

Group III: Combine app + motivational interview Experimental Treatment 2 Interventions

In addition to the other Combine app features, participants will receive a motivational interview within 4 weeks of downloading the app.

Group IV: Combine app + ability to order up 2 free HIV/STI self-test kits Experimental Treatment 2 Interventions

In addition to the other Combine app features, participants in this arm will be able to order up to two HIV/STI self-test kits at no charge during each year of follow-up.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Emory University Atlanta, GA

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1735

Patients Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3007

Patients Recruited

2,852,000+

Findings from Research

Digital STI/HIV services are becoming increasingly important for promoting and facilitating testing, clinical management, and prevention strategies, especially as self-testing technologies advance.

While there is a growing body of evidence supporting these digital services, most studies have been conducted in high-income countries, highlighting a need for more research focused on low- and middle-income countries where STI/HIV burdens are significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital sexually transmitted infection and HIV services across prevention and care continuums: evidence and practical resources. Tucker, JD., Hocking, J., Oladele, D., et al.[2022]

The SMARTtest app, designed to support transgender women using the INSTI Multiplex® HIV/syphilis rapid test, received positive feedback for its ease of use and helpful instructions, indicating it effectively aids in self-testing and interpreting results.

Participants valued the app's feature that provided information on clinics for confirmatory testing, highlighting its potential to improve access to care for transgender women, although they suggested enhancements for better functionality and user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transgender Women's Experiences Using SMARTtest, a Smartphone Application to Facilitate Self- and Partner-HIV/Syphilis Testing Using the INSTI Multiplex. Rael, CT., Kutner, BA., Lentz, C., et al.[2023]

A study involving 60 men and transgender women who have sex with men showed that a smartphone app can effectively support HIV and syphilis self-testing by providing clear video instructions and textual results, addressing user concerns about test interpretation.

Participants expressed a strong preference for features that allow saving and sharing test results with partners or healthcare providers, which were incorporated into the SMARTtest app to enhance user experience and facilitate linkage to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMARTtest: A Smartphone App to Facilitate HIV and Syphilis Self- and Partner-Testing, Interpretation of Results, and Linkage to Care. Balán, IC., Lopez-Rios, J., Nayak, S., et al.[2021]

The study enrolled 2,093 men who have sex with men (MSM), including 1,149 Black or African American MSM and 944 Hispanic or Latino MSM, to evaluate the effectiveness of a mobile app in increasing access to HIV prevention and treatment services.

The research aims to assess innovative recruitment strategies and the impact of providing free HIV self-tests alongside the mobile app on linkage to care, including testing for sexually transmitted infections and initiation of pre-exposure prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial. Dana, R., Sullivan, S., MacGowan, RJ., et al.[2023]

A study involving 38 gay and bisexual men revealed that a mobile app for HIV prevention should focus on engaging and educational content, with features that promote social networking and interactive engagement to encourage regular HIV testing.

Participants emphasized the importance of privacy and trustworthiness in the app's design, suggesting that the language used should be both fun and professional to motivate men to use the app effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for a Mobile HIV Prevention App for Men Who Have Sex With Men. Goldenberg, T., McDougal, SJ., Sullivan, PS., et al.[2018]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Digital sexually transmitted infection and HIV services across prevention and care continuums: evidence and practical resources. [2022]

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

Transgender Women's Experiences Using SMARTtest, a Smartphone Application to Facilitate Self- and Partner-HIV/Syphilis Testing Using the INSTI Multiplex. [2023]

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

SMARTtest: A Smartphone App to Facilitate HIV and Syphilis Self- and Partner-Testing, Interpretation of Results, and Linkage to Care. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Preferences for a Mobile HIV Prevention App for Men Who Have Sex With Men. [2018]

7. 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]

8. Canada pubmed.ncbi.nlm.nih.gov

Mobile phone applications for the care and prevention of HIV and other sexually transmitted diseases: a review. [2021]

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

The Use of Technology to Advance HIV Prevention for Couples. [2018]