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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app designed to assist older adults who have lived with HIV for 20 years or more. The app, part of the COPPEhR Intervention (a technology-based psychosocial intervention), aims to reduce loneliness and depression by enhancing social connections and support. Participants will either use this app or receive a device without the app to compare results. Individuals who have been HIV-positive for at least 20 years and often feel isolated might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve the well-being of long-term HIV survivors.

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 prior data suggests that this technology-based psychosocial intervention is safe for older adults with HIV?

Research has shown that technology-based programs like the COPPEhR app are generally safe to use. This study tests an app designed to help older adults with HIV feel less lonely and more connected. Since the program uses technology, it involves no medications or physical treatments, reducing the risk of side effects compared to drug treatments.

The intervention, a software app, presents minimal safety concerns. The main focus is on its usability and effectiveness. Dr. Sara Czaja's PRISM platform, which serves as the basis for COPPEhR, has been used with seniors before without major safety issues. Therefore, participating in this trial is considered low-risk in terms of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COPPEhR Intervention because it offers a novel approach by integrating technology-based psychosocial support specifically for older adults living with HIV. Unlike traditional treatments that focus primarily on managing the virus with antiretroviral therapy, COPPEhR aims to enhance social support and engagement, addressing the often-overlooked psychosocial aspects of living with HIV. This intervention leverages a digital platform to foster community and connection among participants, which is a new angle in HIV care that could significantly improve quality of life and mental well-being.

What evidence suggests that the COPPEhR intervention is effective for improving well-being in older adults with HIV?

Research shows that technology, such as mobile apps and texting, can assist people living with HIV. These tools improve social connections and mental health. For older adults with HIV, addressing loneliness is crucial. Early studies suggest that technology can enhance social support, potentially reducing loneliness and depression. In this trial, participants in the COPPEhR Intervention arm will access the COPPEhR system, which connects users with resources and support through an easy-to-use app. The goal is to help older adults with HIV feel more connected and resilient. Meanwhile, participants in the Device-only Control Condition arm will receive a device without the COPPEhR system. ^{3 6 7 8 9}

Who Is on the Research Team?

Sara Czaja, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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

20/60 vision with or without correction to ensure they can read a device screen

I am either male or female.

Exclusion Criteria

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

Blind or have visual impairments that limit their ability to view the technology

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2224774/

Deactivation of Human Immunodeficiency Virus Type 1 in ... Human immunodeficiency virus, hepatitis C and hepatitis B infections among ... Table of country-specific HIV/AIDS estimates and data report on the global HIV/AIDS ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12009800/

results from the IMPROVE clustered randomized study Human immunodeficiency virus (HIV)-related Outcomes between participants by study arm. Selected outcomes, Control, Intervention, Total, P-value ...

3. withpower.com withpower.com/trial/phase-hiv-diagnosis-7-2024-43148

Technology-Based Psychosocial Intervention for HIV Research shows that technology-based interventions, like mobile texting, have been effective in improving outcomes for people living with HIV, such as ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00001093?term=primary%20infection%20HIV&viewType=Table&rank=4

Outcomes of Anti-HIV Therapy During Early HIV Infection Immune System Diseases. Slow Virus Diseases. Infections. Communicable Diseases. HIV Infections. Acquired Immunodeficiency Syndrome. About. About ...

5. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/

ViiV Healthcare shows more than 99% effectiveness in real ... We are ViiV Healthcare: 100% dedicated to HIV medicines and research and completely focused on people affected by HIV and AIDS. Visit the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31919240/

Copper intrauterine device use and HIV acquisition in women ... HIV acquisition among users of Cu-IUDs. Keywords: human immunodeficiency virus; intrauterine devices. © Author(s) (or their employer(s)) 2020. Re-use ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02550067

The Evidence for Contraceptive Options and HIV Outcomes ... Initiating Intramuscular Depot Medroxyprogesterone Acetate Increases Frequencies of Th17-like Human Immunodeficiency Virus Target Cells in the Genital Tract ...

8. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(19)31288-7/fulltext

HIV incidence among women using intramuscular depot ... Our results strongly emphasise the need for more aggressive HIV and STI prevention ... therapy on incident AIDS or death. Stat Med. 2009; 28:1725- ...

9. liebertpub.com liebertpub.com/doi/10.1089/bfm.2010.0090

Prevention of Human Immunodeficiency Virus Breastmilk ... Copper inhibits the protease from human immunodeficiency virus 1 by ... therapy for HIV/AIDS in Africa: Choices and consequences. PLoS ...