ACTIVE_NOT_RECRUITING

Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that will be expanded for telehealth outreach to women with health-related social needs (HRSN).

Official Title

Project Tara: Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

Quick Facts

Study Start:2024-08-01
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06411223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Living with diagnosed HIV
  2. * Receiving HIV care-related services from Yale New Haven Health (YNHH)
  3. * Currently on oral ART and virally suppressed for at least 6 months (from electronic health review).
  4. * Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 3 years (from self-report at screening).
  5. * Able to converse comfortably in English or Spanish
  1. * Unable or unwilling to complete informed consent (e.g., have a conservator of person)
  2. * Have initiated CAB/RPV oral lead-in prior to enrollment.
  3. * Have a contraindication to CAB/RPV LA per label.
  4. * Have known or suspected resistance to CAB/RPV
  5. * Pregnant or breast-feeding

Contacts and Locations

Principal Investigator

Jaimie Meyer, MD, MS, FACP
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale Clinical and Community Research
New Haven, Connecticut, 06519
United States

Collaborators and Investigators

Sponsor: Yale University

  • Jaimie Meyer, MD, MS, FACP, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Criminal legal involvement
  • Unstably housed; unhoused
  • Food insecurity
  • Mental health
  • Substance use/ treatment engagement
  • women
  • Long-acting injectable antiretroviral treatment

Additional Relevant MeSH Terms

  • Hiv