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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| COPPEhR Intervention | Experimental | Participants 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 Condition | Placebo comparator | Participants 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.
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
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)
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
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
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
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
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
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
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
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
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.
- First posted19 Aug 2024
- Study start12 Dec 2024
- Primary completion2 May 2026
- Study completion2 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV DiagnosisStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sara Czaja, PhD, Principal investigator, Weill Medical College of Cornell University
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-based Psychosocial Intervention to Support Social Engagement and Well-being in Older Adults With HIV
- ClinicalTrials.gov ID
- NCT06560970
- Acronym / sponsor ID
- COPPEhR / 23-08026417
- Conditions
- HIV Diagnosis
- Keywords
- Technology, Computer, Social Engagement, Well-being, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- 2 May 2026 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPPEhR Intervention | Experimental | Behavioral: COPPEhR InterventionParticipants 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 comparator | Behavioral: Device-only Control ConditionParticipants will have access to a device only without the COPPEhR system. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPPEhR InterventionParticipants will receive access to the COPPEhR system which will provide social support and engagement among older adults diagnosed with HIV. | Behavioural | COPPEhR Intervention |
| Device-only Control ConditionParticipants will have access to a device only without the COPPEhR system. | Behavioural | Device-only Control Condition |
Primary outcome
Mean Difference of Perceived Usefulness and Perceived Ease of Use Questionnaire
Time frame: Post-randomization at month 3 and month 6
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.
Mean Difference of System Evaluation Questionnaire
Time frame: Post-randomization at month 3 and month 6
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.
9 secondary outcomes
Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale
Time frame: Post-randomization at Baseline, month 3, and month 6
Change in Loneliness as Measured by UCLA Loneliness Scale
Time frame: Post-randomization at Baseline, month 3, and month 6
Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire
Time frame: 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)
Time frame: Post-randomization at Baseline, month 3, and month 6
Mean Difference in score of participants self-reported Resilience, assessed by BRS - Brief Resilience Scale
Time frame: Post-randomization at Baseline, month 3, and month 6
Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure
Time frame: Post-randomization at Baseline, month 3, and month 6
Social Engagement using the Lubben Social Network Index (LSNS-6)
Time frame: Post-randomization at Baseline, month 3, and month 6
Medical Outcome Study: Social Support Survey Instrument
Time frame: Post-randomization at Baseline, month 3, and month 6
Mean Difference in score of Social Isolation using the Friendship Scale
Time frame: Post-randomization at Baseline, month 3, and month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Czaja, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
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.