HIVADHOCNCT04311554
Aging With Dignity, Health, Optimism and Community
An observational study of HIV, run by Mazonson & Santas Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 1,049 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 19 Oct 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV
- Keywords
- HIV, PLWH, Aging, Older
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%).
Measured: 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%).
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline, and once a year through study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start20 Oct 2017
- Primary completion19 Oct 2022 (estimated)
- Study completion19 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazonson & Santas Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311554
- Sponsor's protocol ID
- ADHOC-1001
- Acronym
- ADHOC
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37379478
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging With Dignity, Health, Optimism and Community
- ClinicalTrials.gov ID
- NCT04311554
- Acronym / sponsor ID
- ADHOC / ADHOC-1001
- Conditions
- HIV
- Keywords
- HIV, PLWH, Aging, Older
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,049 participants (actual)
- Lead sponsor
- Mazonson & Santas Inc.Industry (pharma, biotech, devices)
- 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
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 19 Oct 2022 (estimated)
- Study completion
- 19 Oct 2022 (estimated)
- First posted
- 17 Mar 2020 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People over the age of 50 with an HIV-1 or -2 infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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%).
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%).
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.
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.
1 secondary outcome
Demographic characteristics
Time frame: Baseline, and once a year through study completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 37379478Mazonson 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Mazonson & Santas Inc. 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?
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: status not confirmed, as of the sponsor's last update on 17 Mar 2020. 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. 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?
Results are not available in the source record.
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?
Change in loneliness (time frame: Through study completion, an average of 1 year). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311554, which also lists 1 linked publication.
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 17 Mar 2020; AzTrials last refreshed its copy on 31 Oct 2026.