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

HIV Clinical Trial

— ADHOC-LA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208541
• Other study ID #: ADHOC-LA 1001
• Status: Recruiting
• Start date: May 20, 2021
• Est. completion date: May 20, 2026

Study information

• Verified date: January 2022
• Source: Mazonson & Santas Inc.
• Contact: Peter Mazonson, MD, MBA
• Phone: 650-520-3960
• Email: pmazonson[@]clearcosthealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 20, 2026
• Est. primary completion date: May 20, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
United States	Mazonson & Santas Inc	Menlo Park	California

Sponsors (17)

Lead Sponsor

Collaborator

Mazonson & Santas Inc.

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic 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
Other	Sociodemographic 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.	Through study completion, an average of 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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