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

309 Participants Needed

Trial Summary

What is the purpose of this trial?

This study called "Peers plus mobile App for Treatment in HIV (PATH)" is a two-arm randomized controlled trial (RCT) evaluating the efficacy of an intervention that combines peer navigation and mobile health (mHealth) technology to support HIV care outcomes among Hispanic and Black Persons Living with HIV (HBPLH).

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.

What data supports the effectiveness of the treatment PATH, MATCH, PATH 2.0 for HIV/AIDS?

Research shows that peer support and mobile technology, like apps and text messaging, can help people with HIV stick to their treatment plans and feel more supported. Studies found that these methods improve medication adherence and retention in care, which are crucial for managing HIV effectively. ^{1 2 3 4 5}

Is the Peer Support + Mobile App for HIV/AIDS generally safe for humans?

The mobile app used for health navigation in Guatemala was found to be easy to use and facilitated timely feedback and training, indicating it is generally safe and acceptable for supporting people living with HIV. ^{6 7 8 9 10}

What makes the PATH treatment for HIV/AIDS unique compared to other treatments?

The PATH treatment is unique because it combines peer support with a mobile app to enhance adherence to antiretroviral therapy (ART) and reduce HIV transmission risk. This approach leverages technology to provide social support and personalized health navigation, which can improve outcomes for people living with HIV by offering emotional and informational support in a convenient and private manner. ^{4 7 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

References

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

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of SMS and peer navigation on retention in HIV care among adults in South Africa: results of a three-arm cluster randomized controlled trial. [2023]

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

Peer support and pager messaging to promote antiretroviral modifying therapy in Seattle: a randomized controlled trial. [2022]

4. United States 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. [2018]

5. United States 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. [2021]

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

Feasibility of Lantern Using WhatsApp to Improve Antiretroviral Therapy Adherence. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A mobile application to monitor mode, content and duration of health navigation services for people living with HIV in Guatemala. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Analysis of self-reported adverse reactions to efavirenz and drug interactions in a population with HIV in Mexico. [2022]

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

Barriers to use of electronic adherence monitoring in an HIV clinic. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Potential drug-drug interactions between antiretroviral drugs and comedications, including dietary supplements, among people living with HIV: A clinical survey. [2023]

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

Computerized counseling reduces HIV-1 viral load and sexual transmission risk: findings from a randomized controlled trial. [2022]

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

CARE+ user study: usability and attitudes towards a tablet pc computer counseling tool for HIV+ men and women. [2018]

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

HIV-Related Knowledge, Attitudes, Behaviors and Experiences of Kenyan Adolescents Living with HIV Revealed in WhatsApp Group Chats. [2021]