Aging With Dignity, Health, Optimism and Community

HIV Clinical Trial

— ADHOC  

Official title:

Aging With Dignity, Health, Optimism and Community

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04311554
• Other study ID #: ADHOC-1001
• Status: Active, not recruiting
• Start date: October 20, 2017
• Est. completion date: October 19, 2022

Study information

• Verified date: March 2020
• Source: Mazonson & Santas Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1049
• Est. completion date: October 19, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
United States	Mazonson & Santas Inc	Larkspur	California

Sponsors (13)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.