HIV
Conditions
Keywords
HIV, PLWH, Long Acting Injectable
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.
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.
Interventions
None listed
Sponsors
AIDS Healthcare Foundation
Be Well Medical Center
Central Texas Clinical Research
The Crofoot Research Center, Inc.
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
Felizarta, Franco, M.D.
Prism Health North Texas
Texas Centers for Infectious Disease Associates
ViiV Healthcare
Mazonson & Santas Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frailty | 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. |
| Loneliness | 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. |
| Quality of life measurement | 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. |
| Cognitive function | 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. |
| Social well-being | 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. |
| Depression | 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. |
| Anxiety | 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. |
| Sleep quality | 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. |
| Alcohol use | 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. |
| Internalized stigma | 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. |
| Resilience | 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. |
| Interpersonal support | 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. |
| Anti-HIV medication adherence | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sociodemographic Characteristics | 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. |
Countries
United States
Contacts
Primary ContactPeter Mazonson, MD, MBA
Backup ContactJeff Berko, MPH
Outcome results
None listed