A Technology-based Psychosocial Intervention to Support Social Engagement and Well-being in Older Adults With HIV
COPPEhR
2 other identifiers
interventional
68
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedStudy Start
First participant enrolled
December 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
April 16, 2026
April 1, 2026
1.5 years
August 15, 2024
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Difference of Perceived Usefulness and Perceived Ease of Use Questionnaire
Utilizing a 12-item scale (Perceived Ease of Use Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from 1 (Strongly disagree) - 7 (Strongly agree). The total score ranges from 12 - 84. The responses to the items are summed for each of the subscales. Higher scores indicate perceived ease of use of the COPPEhR program.
Post-randomization at month 3 and month 6
Mean Difference of System Evaluation Questionnaire
The COPPEhR system or device evaluation will be assessed by evaluating participants' perception of the features of the system. Utilizing an 11-item scale with Likert response scales ranging from 1 (Strongly disagree) - 5 (Strongly agree). The total score ranges from 11 - 55. Higher scores indicate higher degrees of satisfaction with the COPPEhR system, training, technical support.
Post-randomization at month 3 and month 6
Secondary Outcomes (9)
Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale
Post-randomization at Baseline, month 3, and month 6
Change in Loneliness as Measured by UCLA Loneliness Scale
Post-randomization at Baseline, month 3, and month 6
Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire
Post-randomization at Baseline, month 3, and month 6
Mean Difference in score of participants self-reported health, assessed using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form)
Post-randomization at Baseline, month 3, and month 6
Mean Difference in score of participants self-reported Resilience, assessed by BRS - Brief Resilience Scale
Post-randomization at Baseline, month 3, and month 6
- +4 more secondary outcomes
Study Arms (2)
COPPEhR Intervention
EXPERIMENTALParticipants will have access to the COPPEhR system which will provide social support and engagement among older adults diagnosed with HIV.
Device-only Control Condition
PLACEBO COMPARATORParticipants will have access to a device only without the COPPEhR system.
Interventions
Participants will receive access to the COPPEhR system which will provide social support and engagement among older adults diagnosed with HIV.
Participants will have access to a device only without the COPPEhR system.
Eligibility Criteria
You may qualify if:
- Age 50+
- HIV diagnosis for at least 15 years
- Center for Special Studies (CSS) patient
- Able to read English at 6th grade level
- Visually able to read a device screen
- Adequate cognitive status (score above 34) to interact with the technology assessed by the Telephone Interview for Cognitive Status - modified (TICS-M)
- Plan to remain in the area for the next 9 months
You may not qualify if:
- Not a Center for Special Studies (CSS) patient
- 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
- Has a mobility or dexterity impairment that would interfere with the use of a device, mouse, or a keyboard (e.g., tremors, arthritis, etc.)
- Severe psychosis (e.g., aggression)
- Severe cognitive impairment that limits their ability to use the technology
- Participants in previous COPPEhR usability testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medicine
New York, New York, 10065, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Czaja, PhD
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participants will be blind to their assigned condition.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2024
First Posted
August 19, 2024
Study Start
December 12, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The data from research projects will be made available no later than acceptance of publication of the main findings from the final data set. There is no end date to access the data from the research projects.
- Access Criteria
- The investigators agree to share the data with researchers working under an institution with Federal Wide Assurance who agree to a data sharing agreement that stipulates protection of participant privacy and data confidentiality, acknowledgement of COPPEhR, that the data will be used for research purposes only, and that the data will not be transferred to other users. The computerized data will include raw data, derived variables, all necessary documentation as described in the National Archive of Computerized Data on Aging depositor agreement. All data will be de-identified. The investigators will follow the guides published by the US Department of Health and Human Services in this respect. Each data set will include data documentation to ensure that others can use the data set and to minimize confusion. Information about where and how to locate and access the data will be available in any publications and presentations authored by COPPEhR investigators.
The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich COPPEhR database by the larger research community as this will further the impact of COPPEhR and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.