AzTrials
AzTrials

HIV DiagnosisCOPPEhRNCT06560970

A Technology-based Psychosocial Intervention to Support Social Engagement and Well-being in Older Adults With HIV

A study testing COPPEhR Intervention in people with HIV Diagnosis, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
HIV Diagnosis
What is being tested?
COPPEhR Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteUnited States
Study dates
12 Dec 2024to 2 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 who do not meet the inclusion criteria.
  • Participants in previous COPPEhR usability testing

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

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.

Read the detailed description

The development of modern antiretroviral therapies has increased the life expectancy of people living with HIV (PLWH) allowing them to survive into older ages. Older people with HIV (OPH) have an enhanced risk of developing multiple chronic conditions, such as cardiovascular disease, kidney and liver disease, cancer, and cognitive impairment. Also, especially for those who had treatment early, HIV remains stigmatized. OPH live with significant mental health interdependent challenges such as social isolation, loneliness, and depression. Because of stigma and protective withdrawal behaviors, OPH also tend to have limited social networks and opportunities for engagement. In a recent study of people ≥ 50 years of age with HIV, 58% of the sample (N=356) reported experiencing loneliness. Moore and colleagues, found that older adults with HIV in their sample spent a considerable amount of time at home alone engaged in solitary activities.

The consequences of social isolation include lower quality of life and life satisfaction and poorer mental, physical, and cognitive health. With respect to OPH, studies have shown that loneliness is associated with substance abuse, depression, and poorer quality of life. So-Armah and colleagues, using data from the Veterans Aging Cohort study, found that depressive symptoms were associated with all-cause mortality among US veterans with HIV but not among those without HIV infection. To date, there has been limited intervention research directed at psychosocial issues among OPH, especially long-term survivors. In fact, a recent systematic review of psychosocial interventions for older adults with HIV/AIDS found a paucity of psychosocial interventions and few randomized trials and highlighted a need for home-based interventions to enhance the quality of life for adults aging with HIV. As noted by the National Institutes of Health Office of AIDS Research Working Group on HIV \& Aging, research focused on social isolation and behavior is critical for this population.

Technology-based interventions provide a potential solution for enhancing access to instrumental and social support for older adults with HIV and offer unparalleled flexibility in information presentation and facilitates broad implementation of applications. As noted by a recent report from the National Academies of Science, Engineering, and Medicine that focused on social isolation, "technology provides an important set of opportunities for the 'toolkit' of strategies that can help prevent or mitigate social isolation and loneliness in older adults (pg. 9-38)." Studies have examined the impact of access to the Internet on well-being and social outcomes for older adults, and the results are encouraging. For example, use of the Internet was shown to decrease loneliness and increase social contact among a sample of higher use of social technology was linked to higher ratings of health and well-being and lower depressive symptoms. The links between use of social technology and these outcomes were mediated by reductions in loneliness. The investigators conducted an randomized control trial (RCT) that evaluated PRISM, a software system that supports social connectivity, memory, and information access, with older adults at risk for social isolation. Findings indicated that use of PRISM resulted in significantly less loneliness, increased social support and well-being, and an increase in device comfort and proficiency at 6 months.

Recent studies support the importance and acceptability of using technology for aging adults with HIV. Moore and colleagues8 found that older adults with HIV were able to use smart phones to collect ecological momentary assessment data. Findings from a recent study indicated that OPH that participated in an online mindfulness intervention showed reductions in depression, anxiety, and loneliness. The objectives of this proposed development study are to develop and evaluate a technology-based psychosocial intervention, Connecting Older Positive People to Enhance Health and Resilience (COPPEhR), designed to increase social and cognitive engagement and resource access, reduce loneliness, and improve well-being among OPH. COPPEhR will be delivered on a device via an app and the features will be guided by Activity Theory, models of Successful Aging, and Social Engagement, which underscore that social and cognitive engagement are integral to successful aging and that the benefits of social and meaningful engagement include better emotional, physical and cognitive health.

In accordance with these theories, the features of COPPEhR will provide opportunities for social support and connection, social network expansion (e.g., online support groups, buddies/interest groups) and expansion of social capital (community feature) which the investigators postulate will enhance social engagement, which will in turn be linked to less loneliness and better well- being (e.g., less depression) COPPEhR will also be based on our prior NIH funded work; services available at the Center for Special Studies (CSS), which has a clinic for OPH; the resources of the Center on Aging and Behavioral Research (CABR) (Czaja, Director); and the Center for Research and Education on Aging and Technology Enhancement (CREATE) (Czaja, PI).

Conditions
HIV Diagnosis
Being tested
COPPEhR Intervention, Device-only Control Condition
Keywords
Technology, Computer, Social Engagement, Well-being, Older Adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COPPEhR InterventionBehavioural

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

  • Device-only Control ConditionBehavioural

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

Study groups in NCT06560970
Study groupRoleWhat they receive
COPPEhR InterventionExperimentalParticipants will have access to the COPPEhR system which will provide social support and engagement among older adults diagnosed with HIV.
Receives: Behavioral: COPPEhR Intervention
Device-only Control ConditionPlacebo comparatorParticipants will have access to a device only without the COPPEhR system.
Receives: Behavioral: Device-only Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Post-randomization at month 3 and month 6

  2. 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.

    Measured: Post-randomization at month 3 and month 6

Secondary outcomes (9)
  1. Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale

    The CES-D is a self-report depression scale for research in general population. It is a 20 item questionnaire consisting of likert response scales ranging from 0-3 points. The total score range is 0 - 60 points. Higher scores indicate participants have a greater level of self reported depression.

    Measured: Post-randomization at Baseline, month 3, and month 6

  2. Change in Loneliness as Measured by UCLA Loneliness Scale

    To measure degree of loneliness. The 3rd version of the UCLA Loneliness Scale includes positively worded or non-lonely items. It is a 20 item questionnaire consisting of likert response scales ranging from 0-3 points. Higher score indicates a greater degree of loneliness. Range (0-60)

    Measured: Post-randomization at Baseline, month 3, and month 6

  3. Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire

    Will assess the participant's quality of life by having the participant rate different aspects of their life using one of four words: poor, fair, good, or excellent. They are instructed to think about different aspects of their life, like physical health, energy, family, money, and others to assess their situation in each area.

    The Quality of Life questionnaire is a 13-item scale with Likert response scales ranging between 1 and 4 points. The measure's total score can range between 13 - 52 points. A higher total score is reflective of a higher quality of life while a lower score is reflective of a poorer quality of life.

    Measured: Post-randomization at Baseline, month 3, and month 6

  4. Mean Difference in score of participants self-reported health, assessed using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form)

    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. The total measure scores range from 0 - 100. Lower scores = more disability, higher scores = less disability. The 8 subscales or domains are as follows: Physical functioning (10 items); Role limitations due to physical health (4 items); Role limitations due to emotional problems (4 items); Energy/fatigue (4 items); Emotional well-being (5 items); Social functioning (2 items); Pain (2 items); General health (5 items).

    Measured: Post-randomization at Baseline, month 3, and month 6

  5. Mean Difference in score of participants self-reported Resilience, assessed by BRS - Brief Resilience Scale

    The BRS Brief Resilience Scale will assess a person's self-perceived ability to bounce back or recover from stress. This questionnaire/scale has six items. It uses a 5-point Likert scale with 5 response categories - Strongly Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat Agree and Strongly Agree. The total score ranges from 6 - 30. Higher scores indicates a greater level of resilience.

    Measured: Post-randomization at Baseline, month 3, and month 6

  6. Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure

    Scales used to measure two aspects of social isolation: social disconnectedness and perceived isolation, as well as perceived availability of social support. The Social Connectedness measure is a 15-item scale consisting of 3 sections with different likert response scale. Section 1 is a 4 item scale ranging from 0 - 5 points (20 total points). Section 2 is a 6-item scale ranging from 1 - 3 points (18 total points). Section 3 is a 5-item scale ranging from 1 - 5 points (25 total points). The total score ranges from 11 - 63. A higher total score is reflective of increased connectedness, with items 5-7 and items 11-15 reverse scored. Total scores will be summed and then a mean difference in score will be calculated.

    Measured: Post-randomization at Baseline, month 3, and month 6

  7. Social Engagement using the Lubben Social Network Index (LSNS-6)

    The Lubben Social Network Index (LSNS-6) will assess social engagement including family and friends. This scale has 6 items. The score is computed by adding the response of all items. The score ranges between 0-30 with higher scores indicating more social engagement.

    Measured: Post-randomization at Baseline, month 3, and month 6

  8. Medical Outcome Study: Social Support Survey Instrument

    This is a 19-item questionnaire that measures emotional/informational support, tangible support, affectionate support, positive social interaction, and one additional miscellaneous item. The survey/instrument consists of four separate social support subscales and an overall functional support index. The total score ranges from 19 - 95. A higher score for an individual scale or for the overall support index indicates more support.

    Measured: Post-randomization at Baseline, month 3, and month 6

  9. Mean Difference in score of Social Isolation using the Friendship Scale

    This questionnaire/scale has a total of 6 items measuring perceived social isolation. The time frame of the questions is set at 4 weeks. The scale used for this questionnaire is as follows: Almost always = "0"; Most of the time = "1"; About half the time = "2'; Occasionally = "3"; and Not at all = "4". The score range is 0-24. A high score represents social connectedness and a score of "0" indicates complete social isolation.

    Measured: Post-randomization at Baseline, month 3, and month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start12 Dec 2024
  3. Primary completion2 May 2026
  4. Study completion2 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06560970
Sponsor's protocol ID
23-08026417
Other IDs
R21AG074832
Acronym
COPPEhR
Status last verified
Jun 2026
First submitted
15 Aug 2024
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing COPPEhR Intervention in people with HIV Diagnosis, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Difference of Perceived Usefulness and Perceived Ease of Use Questionnaire (time frame: Post-randomization at month 3 and month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in