Technology-Based Psychosocial Intervention for HIV

(COPPEhR Trial)

Overseen By Chelsie Burchett, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Blindness, Deafness, Severe psychosis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

68 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on a technology-based intervention rather than medication changes.

What data supports the effectiveness of the COPPEhR Intervention treatment for HIV?

Research shows that technology-based interventions, like mobile texting, have been effective in improving outcomes for people living with HIV, such as medication adherence and viral suppression. Additionally, psychosocial interventions have shown potential in supporting better HIV outcomes, particularly among adolescents and young people. ^{1 2 3 4 5}

Is the Technology-Based Psychosocial Intervention for HIV safe for humans?

The reviewed studies on technology-based interventions for HIV, such as mobile texting and web-based programs, did not report any safety concerns, suggesting they are generally safe for human use. ^{4 6 7 8 9}

How is the COPPEhR Intervention treatment for HIV different from other treatments?

The COPPEhR Intervention is unique because it uses technology-based psychosocial methods, such as mobile apps and virtual support, to improve medication adherence and self-management for people living with HIV. This approach leverages technology to provide real-time support and personalized follow-up, which is different from traditional treatments that may not offer such interactive and immediate assistance. ^{4 10 11 12 13}

What is the purpose of this trial?

Older people with HIV (OPH) often live with significant mental health challenges such as social isolation, loneliness, and depression. The objectives of this study are to develop and test the usability and feasibility of a technology-based psychosocial intervention program designed to: enhance social engagement and support; facilitate resource access and education; reduce loneliness; and improve well-being among older adults with HIV who are long-term survivors (diagnosed with HIV ≥ 20 years). The program, Connecting Older Positive People to Enhance Health and Resilience (COPPEhR), will build on Dr. Sara Czaja's PRISM (A Personal Reminder and Information Management System for Seniors) platform, and will be an easy-to-use software application (app), preloaded onto a standard device, designed to support social connectivity, memory, and access to resources for older adults at risk for isolation and the programs and services available at the Center for Special Studies (CSS) at Weill Cornell Medicine (WCM). This protocol covers Phase 2 of the study, which will be a pilot randomized controlled efficacy trial will compare the COPPEhR intervention to a device-only control condition. Participants in the control condition will receive the same device as those in the COPPEhR condition without the COPPEhR application. The specific aims of this developmental project are to evaluate the feasibility, usefulness, and usability of a state-of-the art technology-based multicomponent COPPEhR intervention for aging adults with HIV. Our hypothesis is the COPPEhR intervention will be feasible, usable and useful. The hypothesis is that those that use the COPPEhR app will experience less loneliness, less depression, and less social isolation and more social support, more resilience, and more connectivity than those that do not use the COPPEhR app.

Research Team

Sara Czaja, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for older adults with HIV who have been living with the diagnosis for at least 20 years. It aims to help them deal with mental health issues like loneliness and depression by using a technology-based program.

Inclusion Criteria

Able to read English at 6th grade level

I am either male or female.

I have been diagnosed with HIV for 20 years or more.

Exclusion Criteria

I have severe difficulty understanding or using technology due to cognitive issues.

Deaf or have hearing impairments that limit their ability to use the technology

Severe psychosis (e.g., aggression)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the COPPEhR intervention or device-only control for social engagement and well-being

6 months

Monthly virtual check-ins

Follow-up

Participants are monitored for changes in loneliness, social support, and well-being after treatment

3 months

Treatment Details

Interventions

• COPPEhR Intervention
• Device-only Control Condition

Trial Overview The study tests a new app called COPPEhR, designed to improve social connections, memory, and resource access. Participants will either use this app on a provided device or just receive the device without the app in a pilot randomized controlled trial.

Participant Groups

Group I: COPPEhR Intervention Experimental Treatment 1 Intervention

Participants will have access to the COPPEhR system which will provide social support and engagement among older adults diagnosed with HIV.

Group II: Device-only Control Condition Placebo Group 1 Intervention

Participants will have access to a device only without the COPPEhR system.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Psychosocial interventions for adolescents and young people living with HIV (AYPLHIV) can significantly improve treatment adherence by addressing individual needs and empowering them through personalized approaches and self-care skills.

Effective interventions often involve tailored delivery strategies, such as longer durations and digital formats, along with supportive resources like peer support and integration into existing healthcare services, highlighting the importance of a comprehensive support system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Do Psychosocial Interventions for Adolescents and Young People Living With HIV Improve Adherence and Viral Load? A Realist Review. Laurenzi, CA., Melendez-Torres, GJ., Page, DT., et al.[2023]

The NAMWEZA psychosocial support intervention significantly reduced loss to follow-up (LTFU) among people living with HIV (PLH), with LTFU being three times higher in the comparison group that did not receive the intervention.

Both groups showed improvements in clinical outcomes like CD4 count and hemoglobin levels over 24 months, but only the intervention group experienced significant weight gain, suggesting that psychosocial support may enhance overall health and retention in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CLINICAL outcomes and loss to follow-up among people living with HIV participating in the NAMWEZA intervention in Dar es Salaam, Tanzania: a prospective cohort study. Siril, HN., Kaaya, SF., Smith Fawzi, MK., et al.[2022]

Effective psychotherapy for patients with HIV/AIDS requires a comprehensive biopsychosocial assessment that considers the multifaceted impact of the diagnosis on the patient's overall functioning.

A thorough evaluation of mental health, substance abuse, relationships, social support, and overall health is essential for creating a tailored treatment plan with clear goals and objectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy with HIV/AIDS patients: assessment and treatment plan development. Rubenstein, D., Sorrentino, D.[2018]

A review of 45 studies on eHealth interventions for HIV care found that about 75% demonstrated effectiveness in improving Continuum of HIV Care (CoC) outcomes, particularly in medication adherence.

Mobile texting was the most commonly used technology, highlighting its role in enhancing patient engagement and adherence to treatment, although there are still gaps in the development of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Rapid Review of eHealth Interventions Addressing the Continuum of HIV Care (2007-2017). Henny, KD., Wilkes, AL., McDonald, CM., et al.[2019]

In a study involving 27 participants with uncontrolled HIV, a combination of adherence counseling and cognitive behavioral therapy significantly reduced HIV plasma viral load (PVL) over 8 months, indicating improved viral control.

Self-reported adherence to ART improved during the intervention, and negative emotional states decreased, suggesting that addressing psychosocial issues can enhance treatment outcomes for individuals with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Syndemics and Self-care in Individuals with Uncontrolled HIV: An Open Trial of a Transdiagnostic Treatment. Safren, SA., Harkness, A., Lee, JS., et al.[2023]

A web-based intervention (WBI) is being tested for its effectiveness in reducing depressive symptoms and improving well-being among 100 HIV-infected patients, highlighting a potential cost-effective alternative to traditional psychosocial support.

The study, conducted from February to July 2021, aims to show that WBI can serve as an adjunct to medical treatment for HIV patients, potentially enhancing their overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a web-based intervention in patients with chronic human immunodeficiency virus infection: Protocol for a randomized controlled trial. Mao, M., Jiang, G., Jiang, Q.[2022]

The study involved 84 community-dwelling HIV/AIDS patients in rural Alabama who used an Interactive Voice Response (IVR) system to self-monitor their daily HIV risk behaviors over a period of 4-10 weeks.

Results showed that participants who engaged with the IVR system experienced significant reductions in risky sexual behaviors and drug use, indicating that IVR can be an effective tool for risk assessment and behavior modification in rural populations living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive voice response self-monitoring to assess risk behaviors in rural substance users living with HIV/AIDS. Tucker, JA., Blum, ER., Xie, L., et al.[2021]

In a study of 489 southern HIV-infected patients followed for a median of 30 months, 10% experienced HIV-related events, highlighting ongoing risks despite advances in treatment.

Factors such as lower baseline CD4 counts, less time on antiretroviral therapy, and higher levels of psychosocial trauma significantly increased the likelihood of experiencing these events, indicating the importance of comprehensive care beyond just medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of AIDS-related morbidity and mortality in a southern U.S. Cohort. Mugavero, MJ., Pence, BW., Whetten, K., et al.[2007]

The MI+HealthCall intervention, which combines Motivational Interviewing with smartphone technology, showed high feasibility with a 95% daily use rate and excellent patient satisfaction (4.5 out of 5) among adults living with HIV.

Participants using MI+HealthCall experienced significantly greater reductions in drug use and spending compared to those receiving only Motivational Interviewing, indicating its potential effectiveness in addressing substance use issues that can hinder HIV treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. Aharonovich, E., Stohl, M., Cannizzaro, D., et al.[2020]

A systematic review of 12 studies found that technology-based interventions, particularly SMS/text messaging and mobile apps, are effective in improving medication adherence among people living with HIV/AIDS.

The review highlighted significant gaps in research, particularly the need for more technology-driven strategies aimed at enhancing patient engagement, retention in care, and sexual risk reduction for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances (2011-2012) in technology-delivered interventions for people living with HIV. Pellowski, JA., Kalichman, SC.[2022]

The Heart2HAART smartphone application was found to be feasible and user-friendly for participants, with 63.2% reporting no difficulty using it and 94.7% stating that medication reminders did not disrupt their daily activities.

Despite the positive feedback on usability, the study found no significant difference in adherence to HIV medication between those using Heart2HAART and the control group, suggesting that further refinements may be needed for the intervention to enhance medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot feasibility study of Heart2HAART: a smartphone application to assist with adherence among substance users living with HIV. Himelhoch, S., Kreyenbuhl, J., Palmer-Bacon, J., et al.[2022]

In a pilot study with 43 young African American men who have sex with men, the My Personal Health Guide app significantly improved adherence to antiretroviral therapy, with adherence rates increasing from 62% to 88% after 3 months (p = .05).

The app was well-accepted by participants, and while health literacy improved, self-efficacy remained high throughout the study, indicating that the intervention was both feasible and effective in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability, Feasibility, and Preliminary Efficacy of a Theory-Based Relational Embodied Conversational Agent Mobile Phone Intervention to Promote HIV Medication Adherence in Young HIV-Positive African American MSM. Dworkin, MS., Lee, S., Chakraborty, A., et al.[2022]

The VIH-TAVIE™ intervention aims to improve adherence to anti-retroviral therapy (ART) among 232 participants living with HIV by providing personalized online support and education through a virtual nurse, with adherence defined as taking at least 95% of prescribed medication.

The study will measure the effectiveness of this intervention over 6 months, focusing on treatment adherence and additional factors like self-efficacy and emotional support, using a randomized controlled trial design to ensure robust results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial. Côté, J., Godin, G., Guéhéneuc, YG., et al.[2021]

References

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

How Do Psychosocial Interventions for Adolescents and Young People Living With HIV Improve Adherence and Viral Load? A Realist Review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

CLINICAL outcomes and loss to follow-up among people living with HIV participating in the NAMWEZA intervention in Dar es Salaam, Tanzania: a prospective cohort study. [2022]

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

Psychotherapy with HIV/AIDS patients: assessment and treatment plan development. [2018]

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

A Rapid Review of eHealth Interventions Addressing the Continuum of HIV Care (2007-2017). [2019]

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

Addressing Syndemics and Self-care in Individuals with Uncontrolled HIV: An Open Trial of a Transdiagnostic Treatment. [2023]

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

Evaluation of a web-based intervention in patients with chronic human immunodeficiency virus infection: Protocol for a randomized controlled trial. [2022]

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

Interactive voice response self-monitoring to assess risk behaviors in rural substance users living with HIV/AIDS. [2021]

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

Predictors of AIDS-related morbidity and mortality in a southern U.S. Cohort. [2007]

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

HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. [2020]

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

Recent advances (2011-2012) in technology-delivered interventions for people living with HIV. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Pilot feasibility study of Heart2HAART: a smartphone application to assist with adherence among substance users living with HIV. [2022]

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

Acceptability, Feasibility, and Preliminary Efficacy of a Theory-Based Relational Embodied Conversational Agent Mobile Phone Intervention to Promote HIV Medication Adherence in Young HIV-Positive African American MSM. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial. [2021]