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

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 1049

Contacts and Locations

Study Locations

• United States
  • California
    • Larkspur, California, United States, 94939
      • Mazonson & Santas Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics	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.	Baseline, and once a year through study completion.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Anticipated): October 19, 2022
• Study Completion (Anticipated): October 19, 2022

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: HIV; Aging; Older; PLWH
• Other Study ID Numbers: ADHOC-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No