Clinical trial NCT05208541: Advancing Dignity, Health, and Optimism in Connection With Long Acting Injectables
Official title: Advancing Dignity, Health, and Optimism in Connection With Long Acting Injectables
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Keywords: HIV
PLWH
Long Acting Injectable
Lead sponsor: Mazonson & Santas Inc.
Sponsor class: INDUSTRY
Collaborators: name: AIDS Healthcare Foundation
name: Be Well Medical Center
name: Central Texas Clinical Research
name: The Crofoot Research Center, Inc.
name: Gary J. Richmond, MD
name: Hennepin County Medical Center, Minneapolis
name: Icahn School of Medicine at Mount Sinai
name: Infectious Diseases Association of Central VA
name: KC Care Health Center
name: Long Beach Education and Research Consultants
name: Mills Clinical Research
name: North Texas Infectious Disease Consultants
name: Felizarta, Franco, M.D.
name: Prism Health North Texas
name: Texas Centers for Infectious Disease Associates
name: ViiV Healthcare
First posted: 2022-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People over the age of 18 with an HIV-1 infection.

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.

Eligibility 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.

Primary outcomes:
measure: Loneliness
timeFrame: Baseline
measure: Loneliness
timeFrame: Through study completion, an average of 12 months
measure: Quality of life measurement
timeFrame: Baseline
measure: Quality of life measurement
timeFrame: Through study completion, an average of 12 months
measure: Cognitive function
timeFrame: Baseline
measure: Cognitive function
timeFrame: Through study completion, an average of 12 months
measure: Social well-being
timeFrame: Baseline
measure: Social well-being
timeFrame: Through study completion, an average of 12 months
measure: Depression
timeFrame: Baseline
measure: Depression
timeFrame: Through study completion, an average of 12 months
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: Through study completion, an average of 12 months
measure: Sleep quality
timeFrame: Baseline
measure: Sleep quality
timeFrame: Through study completion, an average of 12 months
measure: Alcohol use
timeFrame: Baseline
measure: Alcohol use
timeFrame: Through study completion, an average of 12 months
measure: Internalized stigma
timeFrame: Baseline
measure: Internalized stigma
timeFrame: Through study completion, an average of 12 months
measure: Resilience
timeFrame: Baseline
measure: Resilience
timeFrame: Through study completion, an average of 12 months
measure: Interpersonal support
timeFrame: Baseline
measure: Interpersonal support
timeFrame: Through study completion, an average of 12 months
measure: Anti-HIV medication adherence
timeFrame: Baseline
measure: Anti-HIV medication adherence
timeFrame: Through study completion, an average of 12 months
measure: Frailty
timeFrame: Baseline
measure: Frailty
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
Other outcomes:
measure: Sociodemographic Characteristics
timeFrame: Baseline
measure: Sociodemographic Characteristics
timeFrame: Through study completion, an average of 12 months
Locations:
city: Menlo Park
country: United States
facility: Mazonson & Santas Inc
state: California
Study officials:
References: