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

NCT03952520 | Completed Results DMC

• 3 other identifiers: 18-29011R01DA047876-01IGHID 11844
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Drug Use

Keywords

Cluster randomized controlled implementation trial; Intervention mapping; People who inject drugs; HIV/AIDS; Systems navigation; Psychosocial counseling; Vietnam

Outcome Measures

Primary Outcomes (2)

• Fidelity to SNaP Intervention Procedures

  Fidelity measures whether the SNaP intervention was delivered as intended. Fidelity score = (% Systems navigation sessions completed x Average navigation session quality score) + (% Counseling sessions completed x Average counseling session quality score) Session completion will be assessed by reviewing the navigator and counselor logs, while session quality will be assessed by central implementation team review and scoring of a random 10% of all forms (navigation) and audio-recordings (psychosocial counseling). Test site fidelity score range: 0-200 (Higher score indicates higher fidelity.)

  Measured over 26 months after SNaP implementation in a clinic

• Percent of PWID Who Initiated ART

  Percent of PWID who initiated antiretroviral therapy (ART) among the PWID who initiated SNaP, measured through ART clinic records of consenting PWID and/or self-report. This measures ART uptake among PWID who initiated the SNaP intervention.

  Medical record reviews conducted within 6 months after enrollment; self-report: 6-12 months after enrollment among those who initiated SNaP

Secondary Outcomes (8)

• Percent of PWID Who Were Contacted and Participated in SNaP

  Up to 24 months after implementation of SNaP in a clinic

• Mean Acceptability Score of SNaP by PWID (AIM)

  Up to 24 months after SNap implementation in a clinic

• Mean Acceptability Score of SNaP by Test Site Staff (OADRI)

  24 months after implementation of SNaP in a clinic

• Percent of PWID Who Are Virally Suppressed

  Up to 24 months after implementation of SNaP in a clinic

• Percent of PWID on Medication-Assisted Treatment (MAT)

  Up to 24 months after SNaP implementation in a clinic

Study Arms (2)

Standard Approach (SA)

ACTIVE COMPARATOR

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

Other: Standard Approach (SA)

Tailored Approach (TA)

EXPERIMENTAL

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

Other: Tailored Approach (TA)

Interventions

Standard Approach (SA) OTHER

The multifaceted implementation strategies for SA sites were identified through centralized Intervention Mapping. Before SNaP implementation starts, the specific set of one-size-fits-all implementation strategies was determined through a formal process with investigators, government stakeholders, and clinical representatives.

Standard Approach (SA)

Tailored Approach (TA) OTHER

The Tailored Approach includes the multifaceted strategy that will be offered to the Standard Approach condition. It will also be tailored to match site-specific barriers to implementation of SNaP at that site. The strategy for TA sites involves a 2-day site-specific training, monthly coaching calls, and an external technical assistance hotline to help organizations to tailor implementation strategies to address their site-specific needs. At the 2-day TA training, the TA sites will be guided on developing site-specific implementation plans, in which they may use additional implementation strategies that they have identified themselves or selected from a list developed by the central team.

Tailored Approach (TA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Ohio State University: collaborator
• Johns Hopkins University: collaborator
• Hanoi Medical University: collaborator
• Vietnam Administration for HIV/AIDS Control: collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, Vietnam

Location

Related Publications (3)

• Go VF, Giang LM, Phan HTT, Chen JS, Powell BJ, Bartels SM, Nguyen MXB, Sripaipan T, Nong HTT, Dang LTH, Pham MD, Vo SH, Tran HV, Hoang VTH, Nguyen NTK, Chu AV, Levintow SN, Dowdy DW, Sohn H, Pence BW, Miller WC. Scaling an intervention for the engagement of people with HIV who inject drugs into care in Viet Nam: an implementation-effectiveness, cluster-randomised trial. Lancet Glob Health. 2025 Dec;13(12):e2111-e2121. doi: 10.1016/S2214-109X(25)00331-6.

  PMID: 41240949 DERIVED

• Nguyen MX, Bartels SM, Akiba CF, Sripaipan T, Nong HT, Dang LT, Tran HV, Hoang VT, Le GM, Go VF, Miller WC, Powell BJ. Tracking modifications to implementation strategies: a case study from SNaP - a hybrid type III randomized controlled trial to scale up integrated systems navigation and psychosocial counseling for PWID with HIV in Vietnam. BMC Med Res Methodol. 2024 Oct 26;24(1):249. doi: 10.1186/s12874-024-02367-3.

  PMID: 39462341 DERIVED

• Nguyen MXB, Chu AV, Powell BJ, Tran HV, Nguyen LH, Dao ATM, Pham MD, Vo SH, Bui NH, Dowdy DW, Latkin CA, Lancaster KE, Pence BW, Sripaipan T, Hoffman I, Miller WC, Go VF. Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial. Implement Sci. 2020 Aug 8;15(1):64. doi: 10.1186/s13012-020-01020-z.

  PMID: 32771017 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Results Point of Contact

• Title: Jane Chen, PhD
• Organization: University of North Carolina at Chapel Hill

janechen@live.unc.edu

919-966-2537

Study Officials

• Vivian F Go, PhD, MPH, MA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• William C Miller, MD, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: June 10, 2020
• Primary Completion: July 31, 2023
• Study Completion: May 31, 2024
• Last Updated: May 11, 2025
• Results First Posted: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available 6 months to 5 years after publication of the primary outcomes paper.
• Access Criteria: Other researchers who provide a methodologically sound proposal to study investigators may be provided access to de-identified data from the study. The other researchers must execute a Data Use Sharing Agreement with the University of North Carolina at Chapel Hill (UNC) and obtain the applicable regulatory approvals from their institution before it is permissible for study investigators to share data with the other researchers.

Locations

VN (1)