Clinical trial NCT03952520: Scaling up an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam: an Implementation Trial
Official title: Scaling up HIV Prevention Trials Network (HPTN) 074: a Cluster Randomized Implementation Trial of an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Drug Use
Keywords: Cluster randomized controlled implementation trial
Intervention mapping
People who inject drugs
HIV/AIDS
Systems navigation
Psychosocial counseling
Vietnam
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Ohio State University
name: Johns Hopkins University
name: Hanoi Medical University
name: Vietnam Administration for HIV/AIDS Control
First posted: 2019-05-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fidelity to SNaP Intervention Procedures
timeFrame: Measured over 26 months after SNaP implementation in a clinic
measure: Percent of PWID Who Initiated ART
timeFrame: Medical record reviews conducted within 6 months after enrollment; self-report: 6-12 months after enrollment among those who initiated SNaP
Secondary outcomes:
measure: Percent of PWID Who Were Contacted and Participated in SNaP
timeFrame: Up to 24 months after implementation of SNaP in a clinic
measure: Mean Acceptability Score of SNaP by PWID (AIM)
timeFrame: Up to 24 months after SNap implementation in a clinic
measure: Mean Acceptability Score of SNaP by Test Site Staff (OADRI)
timeFrame: 24 months after implementation of SNaP in a clinic
measure: Percent of PWID Who Are Virally Suppressed
timeFrame: Up to 24 months after implementation of SNaP in a clinic
measure: Percent of PWID on Medication-Assisted Treatment (MAT)
timeFrame: Up to 24 months after SNaP implementation in a clinic
measure: Incremental Cost-Effectiveness Ratio of SA Compared to TA for SNaP Implementation
timeFrame: Up to 24 months after SNaP implementation in a clinic.
measure: Percent of PWID Alive and Remaining on ART
timeFrame: Up to 24 months after SNaP implementation in a clinic
measure: Percent of Clinics Continuing to Offer SNaP After Completion of Study Activities
timeFrame: Up to 37 months after SNaP implementation in a clinic
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Vivian F Go, PhD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: William C Miller, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.