Recruiting

Long Acting Injectables

Sponsor:

Mazonson & Santas Inc.

Code:

NCT05208541

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT05208541

Start date

May 20, 2021

Status verified date

Jan, 2022

Completion date

May 20, 2026

Anticipated

Primary completion date

May 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Loneliness [ Time Frame: Baseline ]
  • Loneliness [ Time Frame: Through study completion, an average of 12 months ]
  • Quality of life measurement [ Time Frame: Baseline ]
  • Quality of life measurement [ Time Frame: Through study completion, an average of 12 months ]
  • Cognitive function [ Time Frame: Baseline ]
  • Cognitive function [ Time Frame: Through study completion, an average of 12 months ]
  • Social well-being [ Time Frame: Baseline ]
  • Social well-being [ Time Frame: Through study completion, an average of 12 months ]
  • Depression [ Time Frame: Baseline ]
  • Depression [ Time Frame: Through study completion, an average of 12 months ]
  • Anxiety [ Time Frame: Baseline ]
  • Anxiety [ Time Frame: Through study completion, an average of 12 months ]
  • Sleep quality [ Time Frame: Baseline ]
  • Sleep quality [ Time Frame: Through study completion, an average of 12 months ]
  • Alcohol use [ Time Frame: Baseline ]
  • Alcohol use [ Time Frame: Through study completion, an average of 12 months ]
  • Internalized stigma [ Time Frame: Baseline ]
  • Internalized stigma [ Time Frame: Through study completion, an average of 12 months ]
  • Resilience [ Time Frame: Baseline ]
  • Resilience [ Time Frame: Through study completion, an average of 12 months ]
  • Interpersonal support [ Time Frame: Baseline ]
  • Interpersonal support [ Time Frame: Through study completion, an average of 12 months ]
  • Anti-HIV medication adherence [ Time Frame: Baseline ]
  • Anti-HIV medication adherence [ Time Frame: Through study completion, an average of 12 months ]
  • Frailty [ Time Frame: Baseline ]
  • Frailty [ Time Frame: Through study completion, an average of 12 months ]

Central Contacts and Locations

Central contacts

Peter Mazonson, MD, MBA

650-520-3960pmazonson@clearcosthealth.com

Jeff Berko, MPH

978-604-0717jberko@clearcosthealth.com

Locations

Mazonson & Santas Inc

Recruiting

Menlo Park, California, United States, 94025

Contacts

Peter Mazonson, MD, MBA

650-520-3960pmazonson@clearcosthealth.com

More Information

Sponsor

Mazonson & Santas Inc.

Last update posted

Jan 26, 2022

Last verified

Jan, 2022

Keywords

  • HIV
  • PLWH
  • Long Acting Injectable

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mazonson & Santas Inc. on 2022-01-26.