Aging With Dignity, Health, Optimism and Community

NCT04311554 | Unknown DMC

• 1 other identifier: ADHOC-1001
• Study Type: observational
• Target: 1,049
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; PLWH; Aging; Older

Outcome Measures

Primary Outcomes (28)

• Change in loneliness

  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.

  Through study completion, an average of 1 year

• Loneliness at 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.

  Baseline

• Change in quality of life

  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.

  Through study completion, an average of 1 year

• Quality of life at 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.

  Baseline

• Change in cognitive function

  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.

  Through study completion, an average of 1 year

• Cognitive function at 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.

  Baseline

• Change in social well-being

  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.

  Through study completion, an average of 1 year

• Social well-being at 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.

  Baseline

• Change in depression

  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).

  Through study completion, an average of 1 year

• Depression at 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).

  Baseline

• Change in anxiety

  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).

  Through study completion, an average of 1 year

• Anxiety at 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).

  Baseline

• Change in sleep quality

  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.

  Through study completion, an average of 1 year

• Sleep quality at 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.

  Baseline

• Change in alcohol use

  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).

  Through study completion, an average of 1 year

• Alcohol use at 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).

  Baseline

• Change in self-perceived stigma

  Measured using the Internalized AIDS-Related Stigma scale (IAS). IAS is a six-item scale designed to measure the construct of internalized stigma.

  Through study completion, an average of 1 year

• Self-perceived stigma at baseline

  Measured using the Internalized AIDS-Related Stigma scale (IAS). IAS is a six-item scale designed to measure the construct of internalized stigma.

  Baseline

• Change in lipodystrophy

  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.

  Through study completion, an average of 1 year

• Lipodystrophy at 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.

  Baseline

• Change in resilience

  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.

  Through study completion, an average of 1 year

• Resilience at 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.

  Baseline

• Change in interpersonal support

  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.

  Through study completion, an average of 1 year

• Interpersonal support at 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.

  Baseline

• Change in anti-HIV medication adherence

  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%).

  Through study completion, an average of 1 year

• Anti-HIV medication adherence at 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%).

  Baseline

• Change in frailty

  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.

  Through study completion, an average of 1 year

• Frailty at 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.

  Baseline

Secondary Outcomes (1)

• Demographic characteristics

  Baseline, and once a year through study completion.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People over the age of 50 with an HIV-1 or -2 infection.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mazonson & Santas Inc.: lead
• Peter Shalit MD and Associates: collaborator
• Red River Family Practice: collaborator
• Central Texas Clinical Research: collaborator
• Rosedale Infectious Diseases: collaborator
• Midland Medical Center: collaborator
• Anthony Mills MD Inc: collaborator
• Stanford University: collaborator
• Whitman-Walker Institute: collaborator
• University of California, San Diego: collaborator
• Ruth M. Rothstein CORE Center: collaborator
• University of Wisconsin, Madison: collaborator
• ViiV Healthcare: collaborator

Study Sites (1)

Mazonson & Santas Inc

Larkspur, California, 94939, United States

Location

Related Publications (1)

• Mazonson P, Berko J, Lowman E, Gilliam B, Nwafor T, Clark A, Zolopa A. Number of Sexual Partners and Patient-Reported Outcomes Among Men Age 50+ with HIV. AIDS Res Hum Retroviruses. 2023 Oct;39(10):541-546. doi: 10.1089/aid.2023.0004. Epub 2023 Jun 28.

  PMID: 37379478 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 17, 2020
• Study Start: October 20, 2017
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

US (1)