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

NCT05208541 | Recruiting DMC

• 1 other identifier: ADHOC-LA 1001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

HIV; PLWH; Long Acting Injectable

Outcome Measures

Primary Outcomes (26)

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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.

  Through study completion, an average of 12 months

• 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).

  Baseline

• 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).

  Through study completion, an average of 12 months

• 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.

  Baseline

• 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 12 months

Other Outcomes (2)

• Sociodemographic Characteristics

  Baseline

• Sociodemographic Characteristics

  Through study completion, an average of 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 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. 3. Age 18 or above 4. Have no known acute medical problem requiring immediate inpatient treatment 5. Able to read and write in English 6. Able and willing to provide online informed consent and to complete the online profile 7. 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mazonson & Santas Inc.: lead
• AIDS Healthcare Foundation: collaborator
• Be Well Medical Center: collaborator
• Central Texas Clinical Research: collaborator
• The Crofoot Research Center, Inc.: collaborator
• Gary J. Richmond, MD: collaborator
• Hennepin County Medical Center, Minneapolis: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Infectious Diseases Association of Central VA: collaborator
• KC Care Health Center: collaborator
• Long Beach Education and Research Consultants: collaborator
• Mills Clinical Research: collaborator
• North Texas Infectious Disease Consultants: collaborator
• Felizarta, Franco, M.D.: collaborator
• Prism Health North Texas: collaborator
• Texas Centers for Infectious Disease Associates: collaborator
• ViiV Healthcare: collaborator

Study Sites (1)

Mazonson & Santas Inc

Menlo Park, California, 94025, United States

RECRUITING

Central Study Contacts

Peter Mazonson, MD, MBA

CONTACT

650-520-3960; pmazonson@clearcosthealth.com

Jeff Berko, MPH

CONTACT

978-604-0717; jberko@clearcosthealth.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 26, 2022
• Study Start: May 20, 2021
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

US (1)