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

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infections; Drug Use

Treatments: Other: Tailored Approach (TA); Other: Standard Approach (SA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03952520

1R01DA047876-01 (U.S. NIH Grant/Contract)

18-2901

IGHID 11844 (Other Identifier)

Details and patient eligibility

About

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.

Full 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), stratified by engagement of site leadership.

At the HIV test sites, the study will enroll:

• A cohort of 630 PWID who are newly diagnosed or previously diagnosed but not on ART will be enrolled for detailed assessments, including follow-up surveys and dried blood spot collection for viral loads. Additional PWID may be enrolled for medical records assessment without recontact. An additional 242 clinic staff will be enrolled to assess implementation outcomes.
• Note that the original design included ~6200 PWID attending the clinics who consented for medical record assessments only. Upon study initiation, the number of PWID with newly diagnosed HIV infection was substantially lower than predicted. The planned cohort sample was then reduced in size to 630 and all PWID meeting eligibility criteria were referred for enrollment in this cohort.
• 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 the cohort PWID or PWID selected for qualitative interviews, maximum study participation time is 24-27 months. For PWID with medical record assessment only, participation is a one-time visit. For HIV test site director boards and staff, maximum time in the study is 24-27 months.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

PWID participants:

1. 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)

2. Age 18 years or older

3. Injection drug use within the past 6 months (self-reported at time of screening)

4. Willing to provide informed consent for the study

Test site director boards and staff:

1. All test site director boards and staff, including the navigators and counselors, at the selected HIV test sites
2. Willing to provide informed consent for the study

Exclusion criteria

PWID participants:

1. Residence outside of the catchment area of local antiretroviral therapy (ART) and medication-assisted treatment (MAT, e.g. methadone) clinics
2. Currently on ART at time of study enrollment (self-reported)
3. Planning to move out of the catchment area within the next 24 months.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Standard Approach (SA)

Active Comparator group

Description:

The Standard Approach is a one-size-fits-all multifaceted implementation strategy that was systematically developed using Intervention Mapping.

Treatment:

Other: Standard Approach (SA)

Tailored Approach (TA)

Experimental group

Description:

The Tailored Approach includes an implementation strategy that will be tailored to match site-specific barriers to implementation of SNaP at that site.

Treatment:

Other: Tailored Approach (TA)