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

NCT ID: NCT05208541

Last Updated: 2022-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2026-05-20

Brief Summary

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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

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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.

Conditions

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HIV

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AIDS Healthcare Foundation

OTHER

Sponsor Role collaborator

Be Well Medical Center

UNKNOWN

Sponsor Role collaborator

Central Texas Clinical Research

UNKNOWN

Sponsor Role collaborator

The Crofoot Research Center, Inc.

INDUSTRY

Sponsor Role collaborator

Gary J. Richmond, MD

UNKNOWN

Sponsor Role collaborator

Hennepin County Medical Center, Minneapolis

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Infectious Diseases Association of Central VA

UNKNOWN

Sponsor Role collaborator

KC Care Health Center

UNKNOWN

Sponsor Role collaborator

Long Beach Education and Research Consultants

UNKNOWN

Sponsor Role collaborator

Mills Clinical Research

INDUSTRY

Sponsor Role collaborator

North Texas Infectious Disease Consultants

UNKNOWN

Sponsor Role collaborator

Felizarta, Franco, M.D.

INDIV

Sponsor Role collaborator

Prism Health North Texas

OTHER

Sponsor Role collaborator

Texas Centers for Infectious Disease Associates

UNKNOWN

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

Mazonson & Santas Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mazonson & Santas Inc

Menlo Park, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Peter Mazonson, MD, MBA

Role: CONTACT

650-520-3960

Jeff Berko, MPH

Role: CONTACT

978-604-0717

Facility Contacts

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Peter Mazonson, MD, MBA

Role: primary

650-520-3960

Other Identifiers

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ADHOC-LA 1001

Identifier Type: -

Identifier Source: org_study_id

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