Peer Support + Mobile App for HIV/AIDS

(PATH Trial)

Overseen By Eileen Pitpitan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Must be taking: HIV medication

Disqualifiers: Under 18, Enrolled in similar study, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to support healthcare for Hispanic and Black individuals living with HIV. It combines guidance from trained peers with a mobile app called PATH to assist in managing HIV treatment. Participants will either receive their usual care or access this new support system. The trial suits individuals living in San Diego who have been diagnosed with HIV, are currently on medication, and have internet access. It specifically targets those who have faced challenges with treatment adherence, such as missing doctor visits or experiencing detectable viral loads. As an unphased trial, this study offers participants the chance to contribute to innovative healthcare solutions and potentially enhance their treatment experience.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since participants must be currently prescribed HIV medication, it seems likely that you will continue your current HIV treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the PATH treatment uses peer support and a mobile app to help people with HIV manage their health. Although specific studies on the safety of this exact program are not available, similar methods using peer support and mobile health tools have generally been safe. These approaches provide information and emotional support rather than physical treatments, so they are usually well-tolerated.

The trial phase is "Not Applicable," indicating it might not involve new drugs or medical procedures that require detailed safety testing. Instead, it examines how support systems can help. This suggests that the PATH treatment likely won't cause serious side effects. It focuses on supporting health and improving care for people living with HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PATH treatment because it combines peer support with a mobile health app to enhance HIV care. Unlike standard care options, which typically involve regular medical appointments and medication adherence, PATH offers personalized guidance from peer navigators. This approach not only provides emotional support but also leverages technology to keep patients engaged and informed about their health. The mobile app acts as a constant companion, providing easy access to resources and reminders, which can lead to improved health outcomes and a better quality of life for individuals living with HIV/AIDS.

What evidence suggests that the PATH intervention could be effective for HIV care outcomes?

Research has shown that combining peer support with mobile health technology can improve health outcomes for people with HIV. In this trial, participants in the PATH Active Intervention Arm will receive HIV care support from a trained peer navigator and access a mobile health web application designed to support their health and HIV care. Past studies have demonstrated that peer guidance helps patients adhere to their HIV treatment plans, resulting in lower viral loads and improved overall health. The mobile app enhances support by providing easy access to health information and reminders. Together, these tools aim to help Hispanic and Black individuals with HIV manage their care more effectively. Early results suggest that this combined approach could improve health by reducing stigma and encouraging regular treatment. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for Hispanic and Black adults living with HIV who are over 18, speak English or Spanish, on HIV medication, have internet access, and plan to stay in San Diego for the next year. They must have had treatment challenges like detectable viral loads while on therapy, missed appointments, infrequent care visits or low adherence to their antiretroviral regimen.

Inclusion Criteria

I have taken my HIV medication less than 90% of the time in the last month.

Meets one or more of the following medical chart verified or self-reported criteria:

Report stimulant or opioid use (non-prescription) in the past 6 months

Exclusion Criteria

I am under 18 years old.

Currently enrolled in any program, intervention, or research study designed to improve antiretroviral therapy adherence or engagement in HIV care (e.g., LinkPositively)

Members of one of the community advisory boards providing advisement on the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PATH intervention, which includes peer navigation and access to a mHealth web application, or usual care

12 months

Follow-up

Participants are monitored for sustained viral suppression and retention in care

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PATH

Trial Overview The PATH study is a randomized controlled trial testing an intervention that combines peer support with a mobile app designed to improve the management of HIV care among participants. It aims to see if this approach can help patients better adhere to treatments and maintain their health.

How Is the Trial Designed?

Group I: Usual Care Active Control 1 Intervention

Participants assigned to this group are in the control arm and will receive standard of care following the Ryan White model of care.

Group II: PATH Active Intervention Arm Active Control 1 Intervention

Participants assigned to this group will receive care as usual if they are assigned to this group. In addition, participants in this arm will receive HIV care support from a trained peer navigator and have access to a mHealth web application designed to support their health and HIV care.

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Published Research Related to This Trial

The Lantern program, which uses WhatsApp to support adherence to HIV medications, was found to be safe, practical, and effective in motivating participants to take their antiretroviral therapy on time during an 8-week pilot study with 30 participants.

Participants reported feeling supported and continued to use medication reminder alarms, indicating that the program is feasible and acceptable for improving adherence to HIV treatment in Indonesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Lantern Using WhatsApp to Improve Antiretroviral Therapy Adherence. Ismail, R., Yona, S., Nurachmah, E., et al.[2023]

In a study of 96 people living with HIV, the most common self-reported adverse reactions to antiretroviral (ARV) treatment included dizziness (53.1%), insomnia (21.9%), and lucid dreams (17.7%), indicating that these side effects are prevalent and may affect treatment adherence.

The study also highlighted that 24% of participants were taking multiple medications, leading to 18 potential drug interactions, suggesting the need for careful monitoring and management of ARV treatments to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of self-reported adverse reactions to efavirenz and drug interactions in a population with HIV in Mexico. Martínez-Salazar, MF., Oaxaca-Navarro, J., Leija-Salas, A., et al.[2022]

The MAPPS training program successfully trained HIV-positive peer mentors to effectively deliver a comprehensive behavioral change intervention aimed at increasing engagement in HIV care, demonstrating both feasibility and effectiveness.

Mentors rated the training program highly, and objective assessments showed they could meet the necessary standards for intervention fidelity, indicating that peer-led approaches can be a valuable strategy in promoting patient self-care in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of a standardized training program for a patient-mentoring intervention to increase adherence to outpatient HIV care. Cully, JA., Mignogna, J., Stanley, MA., et al.[2021]

The CARE+ tablet PC-based counseling tool was found to be usable and effective in promoting honest discussions about sensitive topics related to HIV, as participants felt more comfortable speaking to a computer than a person.

Participants expressed that while they appreciated the privacy and reduced judgment from computer counseling, they still desired some level of human interaction for support, indicating a potential for hybrid counseling approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CARE+ user study: usability and attitudes towards a tablet pc computer counseling tool for HIV+ men and women. Skeels, MM., Kurth, A., Clausen, M., et al.[2018]

Peer navigation programs for people living with HIV have shown positive effects on the continuum of care outcomes, as evidenced by a review of various study designs including randomized control trials and qualitative studies.

Further research is needed to better understand the specific roles of peer navigators in improving health outcomes, mental health, and self-management for individuals with HIV, highlighting the complexity and social nature of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects. Krulic, T., Brown, G., Bourne, A.[2022]

The Positive Links smartphone app facilitated social support among 55 participants living with HIV over 8 months, with 52% of analyzed posts providing support, primarily emotional in nature.

Participants reported feeling a sense of connection and support through the app, although some faced technical issues that hindered their full engagement, highlighting the app's potential to improve care for those unable to access in-person support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support in a Virtual Community: Analysis of a Clinic-Affiliated Online Support Group for Persons Living with HIV/AIDS. Flickinger, TE., DeBolt, C., Waldman, AL., et al.[2018]

Citations

1. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20335-w

Effectiveness of an HIV peer support precision matching platform Examining the associations between HIV-related stigma and health outcomes in people living with HIV/AIDS: a series of meta-analyses. BMJ Open.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38520030/

Peers plus mobile app for treatment in HIV (PATH) - PubMed Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10958824/

Peers plus mobile app for treatment in HIV (PATH) Specifically, participants are asked to authorize the release of their HIV/AIDS treatment information (i.e., lab reports of HIV viral load, HIV ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352013225001103

Development of A Peer Support and Precision Matching ... The Joint United Nations Programme on HIV/AIDS (UNAIDS) has also emphasized the importance of fostering the involvement and contributions of ...

5. researchgate.net researchgate.net/publication/377279125_Effectiveness_of_an_HIV_peer_support_precision_matching_platform_a_randomized_controlled_trial_protocol

(PDF) Effectiveness of an HIV peer support precision ... Li H, Hu Y, Bao M,. et al. Intervention effect research on dietary life behavioral compliance in HIV/AIDS.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27646567/

Progression and Transmission of HIV/AIDS (PATH 2.0) The outcomes focused on average annual transmission rates from 2008 through 2011 by disease stage, HIV care continuum, and sexual risk group.

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/0272989X16668509

Progression and Transmission of HIV/AIDS (PATH 2.0) The model included detailed individual-level data from several large national surveillance databases. The outcomes focused on average annual ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5680124/

Combinations of interventions to achieve a national HIV ... PATH 2.0 is an agent-based stochastic simulation that individually tracks HIV-infected persons, simulating HIV disease progression through a health-state ...

9. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0272989X16668509

Progression and Transmission of HIV/AIDS (PATH 2.0) The model included detailed individual-level data from several large national surveillance databases. The outcomes focused on average annual ...

10. hiv.uw.edu hiv.uw.edu/go/prevention/prevention-positives/core-concept/all

Core Concepts - Preventing HIV Transmission in Persons with ... This graphic shows linked transmissions in the two study groups. Couples in the early therapy arm had a 96% reduction in new HIV transmission events. Source: ...