Scaling up an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam: an Implementation Trial (SNaPR01)

  • STATUS
    Recruiting
  • End date
    Apr 27, 2023
  • participants needed
    6242
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 27 May 2022
drug use
antiretroviral
antiretroviral agents
antiretroviral therapy
hiv test
HIV Vaccine
injection drug

Summary

The purpose of this study is to compare two implementation approaches [Standard Approach (SA) vs. Tailored Approach (TA)] for scaling-up the evidence-based systems navigation and psychosocial counseling integrated intervention (SNaP) in HIV test sites in Vietnam.

Description

This is a cluster randomized, controlled implementation trial to compare two implementation approaches (standard and tailored) for scaling-up the SNaP intervention in 42 HIV test sites in Vietnam. The SNaP intervention combines systems navigation and psychosocial counseling for people who inject drugs (PWID), and it is designed to facilitate PWID's engagement in HIV and substance use care.

The two implementation approaches being compared are:

  • Standard Approach (SA); vs.
  • Tailored Approach (TA)

SNaP is an evidence-based intervention (EBI) that combines systems navigation and psychosocial counseling to facilitate the engagement of HIV-infected people who inject drugs (PWID) into HIV and substance use care.

The 42 HIV test sites will be randomized in a 1:1 ratio to either the standard approach (SA) procedure or a tailored approach (TA).

At the HIV test sites, the study will enroll:

  • Approximately 6200 HIV-infected PWID who are newly diagnosed and not currently on antiretroviral therapy (ART), who consent for medical record assessments. Of those PWID enrolled, a subsample cohort of 1500 PWID will also be enrolled for detailed assessments, including viral load determination, at baseline, 12 and 24 months.
  • HIV test site director boards and staff.

Study activities will span across 5 years, with approximately 27 months at each site and recruitment of PWID participants over 21 months. For PWID not in the subsample cohort, participation is a one-time visit. For the subsample cohort PWID or PWID selected for qualitative interviews, maximum study participation time is 24-27 months. For HIV test site director boards and staff, maximum time in the study is 24-27 months.

Details
Condition HIV Infections, Drug Use
Treatment Standard Approach (SA), Tailored Approach (TA)
Clinical Study IdentifierNCT03952520
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

PWID participants
HIV infection
Newly diagnosed HIV infection, based on confirmatory test, and not currently on ART at the time of study enrollment; or
If previously diagnosed with HIV infection, then must not currently be on ART at the time of study enrollment (self-reported)
Age 18 years or older
Injection drug use within the past 6 months (self-reported at time of screening)
Willing to provide informed consent for the study
Test site director boards and staff
All test site director boards and staff, including the navigators and counselors, at the selected HIV test sites
Willing to provide informed consent for the study

Exclusion Criteria

PWID participants
Residence outside of the catchment area of local antiretroviral therapy (ART) and medication-assisted treatment (MAT, e.g. methadone) clinics
Currently on ART at time of study enrollment (self-reported)
Planning to move out of the catchment area within the next 24 months
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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