- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05208541
Advancing Dignity, Health, and Optimism in Connection With Long Acting Injectables (ADHOC-LA)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Peter Mazonson, MD, MBA
- Phone Number: 650-520-3960
- Email: pmazonson@clearcosthealth.com
Study Contact Backup
- Name: Jeff Berko, MPH
- Phone Number: 978-604-0717
- Email: jberko@clearcosthealth.com
Study Locations
-
-
California
-
Menlo Park, California, United States, 94025
- Recruiting
- Mazonson & Santas Inc
-
Contact:
- Peter Mazonson, MD, MBA
- Phone Number: 650-520-3960
- Email: pmazonson@clearcosthealth.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Eligibility Criteria:
- Have an HIV-1 infection
a) Currently take a long-acting injectable therapy for HIV supplied by ViiV as part of a ViiV-sponsored, long-acting injectables therapy trial (LATTE-2, ATLAS-2M, CUSTOMIZE, POLAR, FLAIR, or SOLAR), or
b) Currently take a long-acting injectable therapy for HIV prescribed by their provider, not in conjunction with a ViiV-sponsored clinical trial, or
c) No longer taking long-acting injectable therapy for HIV, but previously received three or more injections of long-acting injectable therapy, either:
- Supplied by ViiV as part of a ViiV-sponsored, long-acting injectables therapy trial (LATTE-2, ATLAS-2M, CUSTOMIZE, POLAR, FLAIR, or SOLAR), or
- Prescribed by their provider, unrelated to a ViiV-sponsored clinical trial.
- Age 18 or above
- Have no known acute medical problem requiring immediate inpatient treatment
- Able to read and write in English
- Able and willing to provide online informed consent and to complete the online profile
- Not currently enrolled in another clinical trial in which the participant is receiving a long-acting injectable therapy for HIV.
Participants who meet the eligibility criteria but are still receiving ViiV-supplied drug may enroll in the registry, but will not begin the online questionnaire until they are rolled off of ViiV-supplied long-acting injectable therapy.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loneliness
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.
The scale range of each response item is 1-3.
The total score ranges from 3-9 with higher total scores indicating a higher level of perceived loneliness.
|
Baseline
|
Loneliness
Time Frame: Through study completion, an average of 12 months
|
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.
The scale range of each response item is 1-3.
The total score ranges from 3-9 with higher total scores indicating a higher level of perceived loneliness.
|
Through study completion, an average of 12 months
|
Quality of life measurement
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.
The scale range of each response item is 1-5.
The total score is the average of all response items ranges from 1-5 with higher total scores indicating higher quality of life.
|
Baseline
|
Quality of life measurement
Time Frame: Through study completion, an average of 12 months
|
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.
The scale range of each response item is 1-5.
The total score is the average of all response items ranges from 1-5 with higher total scores indicating higher quality of life.
|
Through study completion, an average of 12 months
|
Cognitive function
Time Frame: Baseline
|
Measured using the Functional Assessment of HIV Infection (FAHI Cognition).
The FAHI Cognition subscale is used to create a standardized score to assess outcome.
The scale range of each response is 0-4.
The total score has a range of 0-12 with higher total scores indicating a higher cognitive functioning.
|
Baseline
|
Cognitive function
Time Frame: Through study completion, an average of 12 months
|
Measured using the Functional Assessment of HIV Infection (FAHI Cognition).
The FAHI Cognition subscale is used to create a standardized score to assess outcome.
The scale range of each response is 0-4.
The total score has a range of 0-12 with higher total scores indicating a higher cognitive functioning.
|
Through study completion, an average of 12 months
|
Social well-being
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.
The scale range of each response is 0-4.
The total score has a range of 0-32 with higher total scores indicating better social well-being.
|
Baseline
|
Social well-being
Time Frame: Through study completion, an average of 12 months
|
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.
The scale range of each response is 0-4.
The total score has a range of 0-32 with higher total scores indicating better social well-being.
|
Through study completion, an average of 12 months
|
Depression
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).
The scale range of each response item is 0-3.
The total score for depression has a range from 0-6 with higher scores indicating positive for depression.
|
Baseline
|
Depression
Time Frame: Through study completion, an average of 12 months
|
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).
The scale range of each response item is 0-3.
The total score for depression has a range from 0-6 with higher scores indicating positive for depression.
|
Through study completion, an average of 12 months
|
Anxiety
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).
The scale range of each response item is 0-3.
The total score for anxiety has a range from 0-6 with higher scores indicating positive for generalized anxiety.
|
Baseline
|
Anxiety
Time Frame: Through study completion, an average of 12 months
|
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).
The scale range of each response item is 0-3.
The total score for anxiety has a range from 0-6 with higher scores indicating positive for generalized anxiety.
|
Through study completion, an average of 12 months
|
Sleep quality
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.
The scale range of each response item is 0-100.
The total score is the average of all response items and has a range of 0-100 with higher scores indicating poorer sleep quality.
|
Baseline
|
Sleep quality
Time Frame: Through study completion, an average of 12 months
|
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.
The scale range of each response item is 0-100.
The total score is the average of all response items and has a range of 0-100 with higher scores indicating poorer sleep quality.
|
Through study completion, an average of 12 months
|
Alcohol use
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).
The scale range of each response item is 0-4.
The total score has a range of 0-12 with a higher score indicating more hazardous drinking behavior.
|
Baseline
|
Alcohol use
Time Frame: Through study completion, an average of 12 months
|
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).
The scale range of each response item is 0-4.
The total score has a range of 0-12 with a higher score indicating more hazardous drinking behavior.
|
Through study completion, an average of 12 months
|
Internalized stigma
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.
The scale range of each response item is 0-1.
The total score has a range of 0-6 with higher scores indicating more internalized stigma.
|
Baseline
|
Internalized stigma
Time Frame: Through study completion, an average of 12 months
|
Measured using the Internalized AIDS-Related Stigma scale (IAS).
IAS is a six-item scale designed to measure the construct of internalized stigma.
The scale range of each response item is 0-1.
The total score has a range of 0-6 with higher scores indicating more internalized stigma.
|
Through study completion, an average of 12 months
|
Resilience
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.
The scale range of each response item is 0-8.
The total score range is 0-16 with higher scores indicating higher resilience.
|
Baseline
|
Resilience
Time Frame: Through study completion, an average of 12 months
|
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.
The scale range of each response item is 0-8.
The total score range is 0-16 with higher scores indicating higher resilience.
|
Through study completion, an average of 12 months
|
Interpersonal support
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.
The scale range of each response item is 1-4.
The total score range is 6-48 with higher scores indicating higher social support.
|
Baseline
|
Interpersonal support
Time Frame: Through study completion, an average of 12 months
|
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.
The scale range of each response item is 1-4.
The total score range is 6-48 with higher scores indicating higher social support.
|
Through study completion, an average of 12 months
|
Anti-HIV medication adherence
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%).
Higher score indicates greater adherence to anti-HIV medication(s).
|
Baseline
|
Anti-HIV medication adherence
Time Frame: Through study completion, an average of 12 months
|
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%).
Higher score indicates greater adherence to anti-HIV medication(s).
|
Through study completion, an average of 12 months
|
Frailty
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.
|
Baseline
|
Frailty
Time Frame: Through study completion, an average of 12 months
|
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 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic Characteristics
Time Frame: Baseline
|
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
|
Sociodemographic Characteristics
Time Frame: Through study completion, an average of 12 months
|
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.
|
Through study completion, an average of 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ADHOC-LA 1001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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