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Aging With Dignity, Health, Optimism and Community (ADHOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04311554
Recruitment Status : Active, not recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
Peter Shalit MD and Associates
Red River Family Practice
Central Texas Clinical Research
Rosedale Infectious Diseases
Midland Medical Center
Anthony Mills MD Inc
Stanford University
Whitman-Walker Institute
University of California, San Diego
Ruth M. Rothstein CORE Center
University of Wisconsin, Madison
ViiV Healthcare
Information provided by (Responsible Party):
Mazonson & Santas Inc.

Brief Summary:
ADHOC is an observational study of people living with HIV over the age of 50. Data from this study will be used to research the interaction between HIV and aging.

Condition or disease
HIV

Detailed Description:
ADHOC is an observational study that collects data on PLWH over the age of 50 using an online questionnaire. The questionnaire includes information on sociodemographic factors, activities and interests, HIV diagnosis and status, health care use and satisfaction, antiretroviral therapy, comorbid medical conditions, health and well-being, substance use, and sexual practices.

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Study Type : Observational
Actual Enrollment : 1049 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Aging With Dignity, Health, Optimism and Community
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : October 19, 2022
Estimated Study Completion Date : October 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Change in loneliness [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Three-Item Loneliness Scale. This scale is comprised of 3 questions that measure three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation.

  2. Loneliness at baseline [ Time Frame: Baseline ]
    Measured using the Three-Item Loneliness Scale. This scale is comprised of 3 questions that measure three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation.

  3. Change in quality of life [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the PozQoL. PozQoL is a short 13-question scale assessing quality of life among people living with HIV. The scale includes four subscales: health concerns, psychological, social and functional.

  4. Quality of life at baseline [ Time Frame: Baseline ]
    Measured using the PozQoL. PozQoL is a short 13-question scale assessing quality of life among people living with HIV. The scale includes four subscales: health concerns, psychological, social and functional.

  5. Change in cognitive function [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Functional Assessment of HIV Infection (FAHI Cognition). The FAHI Cognition subscale will be used to create a standardized score to assess outcome.

  6. Cognitive function at baseline [ Time Frame: Baseline ]
    Measured using the Functional Assessment of HIV Infection (FAHI). The FAHI Cognition subscale will be used to create a standardized score to assess outcome.

  7. Change in social well-being [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Functional Assessment of HIV Infection (FAHI). The FAHI Social Well-being subscale will be used to create a standardized score to assess outcome.

  8. Social well-being at baseline [ Time Frame: Baseline ]
    Measured using the Functional Assessment of HIV Infection (FAHI). The FAHI Social Well-being subscale will be used to create a standardized score to assess outcome.

  9. Change in depression [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).

  10. Depression at baseline [ Time Frame: Baseline ]
    Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).

  11. Change in anxiety [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).

  12. Anxiety at baseline [ Time Frame: Baseline ]
    Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).

  13. Change in sleep quality [ Time Frame: Through study completion, an average of 1 year ]
    Measured using The Medical Outcomes Study Sleep Scale (MOS-SS). MOS-SS includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache.

  14. Sleep quality at baseline [ Time Frame: Baseline ]
    Measured using The Medical Outcomes Study Sleep Scale (MOS-SS). MOS-SS includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache.

  15. Change in alcohol use [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Alcohol Use Disorder Identification Test (AUDIT-C). The AUDIT-C is a 3-item screening survey that can help identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence).

  16. Alcohol use at baseline [ Time Frame: Baseline ]
    Measured using the Alcohol Use Disorder Identification Test (AUDIT-C). The AUDIT-C is a 3-item screening survey that can help identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence).

  17. Change in self-perceived stigma [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Internalized AIDS-Related Stigma scale (IAS). IAS is a six-item scale designed to measure the construct of internalized stigma.

  18. Self-perceived stigma at baseline [ Time Frame: Baseline ]
    Measured using the Internalized AIDS-Related Stigma scale (IAS). IAS is a six-item scale designed to measure the construct of internalized stigma.

  19. Change in lipodystrophy [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Assessment of Body Change and Distress (ABCD). The ABCD assesses subjective report of bodily changes and body dissatisfaction, and it includes 20 items on the impact of bodily changes on psychosocial variables, quality of life, and HIV self-care behaviors.

  20. Lipodystrophy at baseline [ Time Frame: Baseline ]
    Measured using the Assessment of Body Change and Distress (ABCD). The ABCD assesses subjective report of bodily changes and body dissatisfaction, and it includes 20 items on the impact of bodily changes on psychosocial variables, quality of life, and HIV self-care behaviors.

  21. Change in resilience [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Connor-Davidson Resilience Scale (CD-RISC 2). The CD-RISC contains two items and was developed as a measure of "bounce-back" and adaptability.

  22. Resilience at baseline [ Time Frame: Baseline ]
    Measured using the Connor-Davidson Resilience Scale (CD-RISC 2). The CD-RISC contains two items and was developed as a measure of "bounce-back" and adaptability.

  23. Change in interpersonal support [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Interpersonal Support Evaluation Checklist - 6 (ISEL-6). ISEL-6 is derived from the long form of the ISEL and contains 6 items that assess the perceived availability of social support.

  24. Interpersonal support at baseline [ Time Frame: Baseline ]
    Measured using the Interpersonal Support Evaluation Checklist - 6 (ISEL-6). ISEL-6 is derived from the long form of the ISEL and contains 6 items that assess the perceived availability of social support.

  25. Change in anti-HIV medication adherence [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the brief adherence self-report questionnaire. This questionnaire asks participants how much of their anti-HIV medications they have taken over the past month (0 to 100%).

  26. Anti-HIV medication adherence at baseline [ Time Frame: Baseline ]
    Measured using the brief adherence self-report questionnaire. This questionnaire asks participants how much of their anti-HIV medications they have taken over the past month (0 to 100%).

  27. Change in frailty [ Time Frame: Through study completion, an average of 1 year ]
    Measured using the Frailty Index Elders (FIFE). FIFE is a 10-item instrument with scores ranging from 0-10. A score of 0 indicates no frailty; a score of 1-3 indicates frailty risk; and a score of 4 or greater indicates frailty.

  28. Frailty at baseline [ Time Frame: Baseline ]
    Measured using the Frailty Index Elders (FIFE). FIFE is a 10-item instrument with scores ranging from 0-10. A score of 0 indicates no frailty; a score of 1-3 indicates frailty risk; and a score of 4 or greater indicates frailty.


Secondary Outcome Measures :
  1. Demographic characteristics [ Time Frame: Baseline, and once a year through study completion. ]
    Demographic characteristics including, but not limited to, age, sex, race, body weight, income, and education will be evaluated as potential predictors of inter- and intra-participant variability for patient-reported outcome measures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People over the age of 50 with an HIV-1 or -2 infection.
Criteria

Eligibility criteria:

  • have an HIV-1 or -2 infection,
  • be ≥ 50 years of age,
  • have no known acute medical problems requiring immediate inpatient treatment,
  • be able to read and write in English, and
  • be able and willing to provide online informed consent and complete the profile online.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311554


Locations
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United States, California
Mazonson & Santas Inc
Larkspur, California, United States, 94939
Sponsors and Collaborators
Mazonson & Santas Inc.
Peter Shalit MD and Associates
Red River Family Practice
Central Texas Clinical Research
Rosedale Infectious Diseases
Midland Medical Center
Anthony Mills MD Inc
Stanford University
Whitman-Walker Institute
University of California, San Diego
Ruth M. Rothstein CORE Center
University of Wisconsin, Madison
ViiV Healthcare
  Study Documents (Full-Text)

Documents provided by Mazonson & Santas Inc.:
Informed Consent Form  [PDF] October 2, 2019

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Responsible Party: Mazonson & Santas Inc.
ClinicalTrials.gov Identifier: NCT04311554    
Other Study ID Numbers: ADHOC-1001
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mazonson & Santas Inc.:
HIV
PLWH
Aging
Older