N/A
N=277
Scaling up an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam: an Implementation Trial
HIV Infections · Drug Use
Bottom Line
View on ClinicalTrials.gov: NCT03952520 ↗Enrolled (actual)
277
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Fidelity to SNaP Intervention Procedures — 114.1; 151.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Approach (SA) (Other); Tailored Approach (TA) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fidelity to SNaP Intervention Procedures |
114.1; 151.4 | — |
| PRIMARY Percent of PWID Who Initiated ART |
98.6; 99.5 | — |
| SECONDARY Percent of PWID Who Were Contacted and Participated in SNaP |
100; 100 | — |
| SECONDARY Mean Acceptability Score of SNaP by PWID (AIM) |
16.7; 16.8 | — |
| SECONDARY Mean Acceptability Score of SNaP by Test Site Staff (OADRI) |
37.7; 37.1 | — |
| SECONDARY Percent of PWID Who Are Virally Suppressed |
43.0; 59.3 | — |
| SECONDARY Percent of PWID on Medication-Assisted Treatment (MAT) |
10.9; 12.8 | — |
| SECONDARY Incremental Cost-Effectiveness Ratio of SA Compared to TA for SNaP Implementation |
25,872.75 | — |
| SECONDARY Percent of PWID Alive and Remaining on ART |
74.5; 84.3 | — |
| SECONDARY Percent of Clinics Continuing to Offer SNaP After Completion of Study Activities |
33; 57 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03952520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.