NCT07200973

Brief Summary

This study will implement an adapted peer navigation intervention to improve linkage to and retention in HIV care for people living with HIV who experience substance use within Los Angeles County.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
28mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Oct 2028

First Submitted

Initial submission to the registry

September 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

September 23, 2025

Last Update Submit

September 30, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with HIV Viral Suppression

    Measured via HIV Viral Load (copies/mL)

    From enrollment to the end of intervention period at 24 weeks

  • Number of Participants with HIV Care Adherence

    Participants' engagement in their HIV care, defined by attendance at scheduled HIV medical appointments

    From enrollment to the end of intervention period at 24 weeks

Secondary Outcomes (2)

  • Number of Participants with HIV Antiretroviral (ART) Adherence

    From enrollment to the end of intervention period at 24 weeks

  • Number of Participants with Recent Substance Use

    From enrollment to the end of intervention period at 24 weeks

Study Arms (1)

Adapted LINK-LA Peer Case Management

EXPERIMENTAL

LINK-LA Peer Case Management Intervention, adapted for people living with HIV who use substances

Behavioral: Adapted LINK LA Peer Navigator

Interventions

Our study will adapt the LINK LA peer navigation intervention (NCT01406626) for the current context (e.g., HIV care provision, substance use risk environments, etc.) and measure its effects on participants' HIV and substance care engagement.

Adapted LINK-LA Peer Case Management

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living with HIV
  • Assigned male sex at birth
  • Willing to return for follow-up study visits every six months as long as the study is ongoing and be available to return for all study visits, barring unforeseen circumstances
  • Willing and able to provide written informed consent to take part in the study
  • Willing and able to provide adequate information for locator purposes
  • Willing to undergo repeat HIV viral load testing at select study visits
  • Willing to undergo substance use testing at each study visit

You may not qualify if:

  • Born biologically female
  • Unwilling or unable to provide reliable contact information
  • Unwilling to provide urine or blood
  • Any other condition or prior therapy that, in the opinion of the research staff would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease, among others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 1, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

October 6, 2025

Record last verified: 2025-09