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HIVADHOC-LANCT05208541

Advancing Dignity, Health, and Optimism in Connection With Long Acting Injectables

An observational study of HIV, run by Mazonson & Santas Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

ADHOC-LA is an observational study of people living with HIV who either are taking, or have taken, a long-acting injectable therapy to manage their HIV. Data from this study will be used to research the ways in which HIV impacts the lives of these patients. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV
How many people
200 participants
Where
1 siteUnited States
Study dates
20 May 2021to 20 May 2026
How long will I take part?
5 Years
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: People over the age of 18 with an HIV-1 infection.

Eligibility Criteria:

  1. Have an HIV-1 infection
  2. 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
  3. Currently take a long-acting injectable therapy for HIV prescribed by their provider, not in conjunction with a ViiV-sponsored clinical trial, or
  4. 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.
  1. Age 18 or above
  2. Have no known acute medical problem requiring immediate inpatient treatment
  3. Able to read and write in English
  4. Able and willing to provide online informed consent and to complete the online profile
  5. 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.

Trial locations and contacts

1 site in 1 country.

Peter Mazonson, MD, MBA contact

650-520-3960

pmazonson@clearcosthealth.com

United States1 site, 1 recruiting
  • Mazonson & Santas Inc

    Menlo Park, California, 94025

    Peter Mazonson, MD, MBA, 650-520-3960, pmazonson@clearcosthealth.com

    Recruiting

Other trials in United States

About this study

ADHOC-LA is an observational study of people living with HIV who either are taking, or have taken, a long-acting injectable therapy to manage their HIV. Data from this study will be used to research the ways in which HIV impacts the lives of these patients.

Read the detailed description

ADHOC-LA is an observational study that uses an online questionnaire to collect data on adults living with HIV who are currently taking, or have previously taken, long-acting injectable therapy to manage their HIV. 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, Long Acting Injectable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. 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.

    Measured: Baseline

  2. 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. 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.

    Measured: Through study completion, an average of 12 months

  3. Quality of life measurement

    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.

    Measured: Baseline

  4. Quality of life measurement

    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.

    Measured: Through study completion, an average of 12 months

  5. Cognitive function

    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.

    Measured: Baseline

  6. Cognitive function

    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.

    Measured: Through study completion, an average of 12 months

  7. 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. 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.

    Measured: Baseline

  8. 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. 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.

    Measured: Through study completion, an average of 12 months

  9. 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). 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.

    Measured: Baseline

  10. 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). 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.

    Measured: Through study completion, an average of 12 months

  11. 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). 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.

    Measured: Baseline

  12. 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). 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.

    Measured: Through study completion, an average of 12 months

  13. 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. 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.

    Measured: Baseline

  14. 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. 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.

    Measured: Through study completion, an average of 12 months

  15. 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). 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.

    Measured: Baseline

  16. 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). 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.

    Measured: Through study completion, an average of 12 months

  17. Internalized stigma

    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.

    Measured: Baseline

  18. Internalized stigma

    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.

    Measured: Through study completion, an average of 12 months

  19. 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. The scale range of each response item is 0-8. The total score range is 0-16 with higher scores indicating higher resilience.

    Measured: Baseline

  20. 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. The scale range of each response item is 0-8. The total score range is 0-16 with higher scores indicating higher resilience.

    Measured: Through study completion, an average of 12 months

  21. 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. The scale range of each response item is 1-4. The total score range is 6-48 with higher scores indicating higher social support.

    Measured: Baseline

  22. 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. The scale range of each response item is 1-4. The total score range is 6-48 with higher scores indicating higher social support.

    Measured: Through study completion, an average of 12 months

  23. 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%). Higher score indicates greater adherence to anti-HIV medication(s).

    Measured: Baseline

  24. 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%). Higher score indicates greater adherence to anti-HIV medication(s).

    Measured: Through study completion, an average of 12 months

  25. 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: Baseline

  26. 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 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start20 May 2021
  3. Primary completion20 May 2026 (estimated)
  4. Study completion20 May 2026 (estimated)

Resources

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
200 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05208541
Sponsor's protocol ID
ADHOC-LA 1001
Acronym
ADHOC-LA
Status last verified
Jan 2022
First submitted
21 Dec 2021
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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 26 Jan 2022. 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?

Contact Peter Mazonson, MD, MBA (650-520-3960, pmazonson@clearcosthealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loneliness (time frame: Baseline). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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