Mobile App for HIV Prevention

(CombineApp Trial)

Overseen By Kristin Wall, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Unable to provide consent

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

Compensation: Varies

Number of Visits: 6

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app can increase HIV and STI testing and the use of PrEP (a preventive HIV medication) among gay, bisexual, and other men who have sex with men (GBMSM) in rural Southern U.S. Participants will use the Combine mobile app and may receive self-test kits and motivational interviews to enhance their engagement in HIV prevention. The study will compare different combinations of these features to identify the most effective approach. Ideal participants are HIV-negative or unsure of their status, have not used PrEP, and have had anal sex with a man in the past year. As an unphased trial, this study offers participants the chance to contribute to innovative HIV prevention strategies in their community.

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 prior data suggests that this mobile app is safe for HIV prevention?

Research has shown that the Combine mobile app increases HIV and STI testing. Users of similar apps have experienced positive outcomes without major safety issues. Motivational interviews have helped users plan more effectively for app usage, without causing significant negative effects.

For those using the app with the option to order self-test kits, studies found that this feature led to more frequent testing. These self-test kits are generally safe and easy to use, providing quick results and simple sample collection.

Overall, previous studies have shown that the components of this trial—the Combine app, motivational interviews, and self-test kits—are safe. There have been no major reports of negative effects, suggesting these methods are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to prevent HIV using a mobile app. Unlike traditional prevention methods, which often rely on regular clinic visits for testing and counseling, this app offers several features that enhance accessibility and convenience. Participants can access an HIV/STI testing locator, receive motivational interviews, and even order free self-test kits directly through the app. This approach aims to make preventive care more engaging and accessible, potentially reaching wider audiences and encouraging proactive health management.

What evidence suggests that this trial's treatments could be effective for increasing HIV and STI testing and PrEP uptake?

Research has shown that mobile apps like Combine can increase HIV and STI testing and encourage the use of pre-exposure prophylaxis (PrEP) among rural men who have sex with men. This trial will evaluate different versions of the Combine app. One arm will offer the app with all features except the ability to order self-test kits. Another arm will include a motivational interview to encourage testing and prevention. A third arm will allow participants to order up to two free HIV/STI self-test kits each year. The final arm combines both the motivational interview and the ability to order test kits via the app. Studies have found that mobile health technology is a promising way to improve HIV prevention. Together, these tools have shown potential to enhance health habits and prevent the spread of HIV. ^{1 3 4 6 7}

Who Is on the Research Team?

Jeb Jones, PhD

Principal Investigator

Rollins School of Public Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Combine mobile app
• HIV/STI testing
• Motivational interview

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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 HealthMindr app is being tested in a randomized controlled trial with 657 men who have sex with men (MSM) in three southern US cities to see if it can effectively increase the uptake of pre-exposure prophylaxis (PrEP), a key HIV prevention method.

Participants using the full HealthMindr app will have access to valuable resources about PrEP and HIV prevention, while the control group will have limited access, allowing researchers to measure the app's impact on PrEP uptake over 12 months.

NCBI (Pubmed)

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. Jones, J., Dominguez, K., Stephenson, R., et al.[2020]

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 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]

Recent literature indicates a shift towards couple-based HIV prevention strategies, with technology playing a crucial role in enhancing these efforts, particularly in recruitment and data collection.

The review highlights the need for further development of mobile health (mHealth) and electronic health (eHealth) interventions tailored for couples, leveraging the widespread use of smartphones and the Internet to improve HIV prevention outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

Out of 1937 mobile apps related to HIV and STDs, only 55 met the criteria for effective prevention and care, with most apps providing basic disease information but lacking comprehensive resources for testing and safer sex practices.

Despite the potential of these apps, they are not widely downloaded or highly rated, indicating a need for public health practitioners to collaborate with developers to enhance their effectiveness and user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone applications for the care and prevention of HIV and other sexually transmitted diseases: a review. Muessig, KE., Pike, EC., Legrand, S., et al.[2021]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40699887/

Evaluating the Effectiveness of a Mobile HIV Prevention App ... Objective: This study aims to determine the effectiveness of the Combine app to increase HIV testing, STI testing, and PrEP initiation among ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12329388/

Evaluating the Effectiveness of a Mobile HIV Prevention ... This study aims to determine the effectiveness of the Combine app to increase HIV testing, STI testing, and PrEP initiation among rural ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04710784

A Pragmatic Trial to Expand Youth-friendly HIV Self-testing The primary outcome will be ascertained using a photographic verification approach via a mobile application or a USSD (Unstructured Supplementary Service Data) ...

4. rti.org rti.org/publication/hiv-self-testing-sti-self-collection-via-mobile-apps-experiences-two-pilot-randomized-controlled-tri

HIV self-testing and STI self-collection via mobile apps Both HIV self-testing and STI self-collection kits were highly acceptable, and 87% reported that it was extremely/very helpful to be able to order these kits ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06205368/evaluating-the-effectiveness-of-a-mobile-hiv-prevention-app-to-increase-hiv-and-sexually-transmitted-infections-sti-testing-and-prep-initiation-among-rural-men-who-have-sex-with-men

Evaluating the Effectiveness of a Mobile HIV Prevention ... 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 ...

6. sciencedirect.com sciencedirect.com/org/science/article/pii/S1438887121002569

Development and Evaluation of a Mobile App Designed to ... The aim of this study is to describe the development and evaluate the feasibility and acceptability of the MyChoices app, a mobile app designed to increase HIV ...

7. jmir.org jmir.org/2024/1/e58591/

Effects of HIV Self-Testing on Testing Promotion and Risk ... This study aims to evaluate the effects of HIVST on changes in HIV testing behavior, frequency of condomless sex, and partner numbers among transgender women ...