NCT05320835

Brief Summary

A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
285

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
13mo left

Started Apr 2022

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
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 Progress79%
Apr 2022May 2027

First Submitted

Initial submission to the registry

March 30, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Expected
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

March 30, 2022

Last Update Submit

May 2, 2025

Conditions

HIV InfectionsHCVDrug Overdose

Outcome Measures

Primary Outcomes (2)

  • Overdose prevention

    Frequency of carrying naloxone

    6 months

  • HIV/HCV prevention

    Frequency of using used cookers

    6 months

Secondary Outcomes (2)

  • Overdose behaviors

    6 months

  • Overdose behaviors 2

    6 months

Study Arms (2)

Experimental

EXPERIMENTAL

behavioral training with 6 sessions

Behavioral: HIV, HCV and overdose prevention

comparison

ACTIVE COMPARATOR

Attention control

Behavioral: HIV, HCV and overdose prevention

Interventions

HIV, HCV and overdose preventionBEHAVIORAL

HIV, HCV and overdose prevention

Experimentalcomparison

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current drug user (opioid use in the prior two weeks)

You may not qualify if:

  • Any mental or physical health impairment that impedes ability to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lighthouse Studies at Peer Point

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

HIV InfectionsDrug Overdose

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPrescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

  • Carl Latkin, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Latkin, PhD

CONTACT

410-955-3972carl.latkin@jhu.edu

Lauren Dayton, PhD

CONTACT

4105025368ldayton2@jhu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Equal attention
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial (RCT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 11, 2022

Study Start

April 30, 2022

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 30, 2027

Last Updated

May 6, 2025

Record last verified: 2025-05

Locations

US(1)