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

Not Applicable

Completed

• Conditions: Drug Use; HIV Infections
• Interventions: Other: Tailored Approach (TA); Other: Standard Approach (SA)

• Registration Number: NCT03952520
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Study Start: 2020-06-10
• Primary Completion: 2023-07-31
• Results First Submitted: 2024-05-30
• Study Completion: 2024-05-31
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Results First Posted: 2024-07-23
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored Approach (TA)	Tailored Approach (TA)	The Tailored Approach includes an implementation strategy that will be tailored to match site-specific barriers to implementation of SNaP at that site.
Standard Approach (SA)	Standard Approach (SA)	The Standard Approach is a one-size-fits-all multifaceted implementation strategy that was systematically developed using Intervention Mapping.

Primary Outcome Measures

Name	Time	Method
Percent of PWID Who Initiated ART	Medical record reviews conducted within 6 months after enrollment; self-report: 6-12 months after enrollment among those who initiated SNaP	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.
Fidelity to SNaP Intervention Procedures	Measured over 26 months after SNaP implementation in a clinic	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.)

Secondary Outcome Measures

Name	Time	Method
Percent of PWID Who Were Contacted and Participated in SNaP	Up to 24 months after implementation of SNaP in a clinic	Penetration of SNaP at the test sites is assessed by this measure. Penetration of SNaP is defined as the proportion of newly diagnosed or previously diagnosed and not currently on ART PWID at test sites who are contacted by a navigator and/or counselor and participate in a SNaP session.; Penetration of SNaP will be assessed at 12 and 24 months after implementation of SNaP in a clinic. Only the 24-month assessment is reported.
Percent of PWID Who Are Virally Suppressed	Up to 24 months after implementation of SNaP in a clinic	Percent of PWID who are virally suppressed among the PWID who initiated SNaP. Viral suppression is defined as \<1000 copies/mL. (This outcome will be measured only in the PWID subsample cohort.) Percent of PWID virally suppressed will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. Only the first assessment collected for a participant is reported.
Percent of PWID on Medication-Assisted Treatment (MAT)	Up to 24 months after SNaP implementation in a clinic	Percent of PWID alive and on MAT among the PWID who initiated SNaP, measured through medical records and/or self-report of consenting PWID. This measures MAT uptake among PWID who initiated SNaP. Percent of PWID on MAT will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. Only the first assessment collected for a participant is reported.
Mean Acceptability Score of SNaP by PWID (AIM)	Up to 24 months after SNap implementation in a clinic	Acceptability is the perception that the SNaP intervention is agreeable, palatable, or satisfactory to PWID. Acceptability among PWID participants will be assessed using the Acceptability of Intervention Measure (AIM), which consists of 4 items containing responses on a 5-point Likert scale. The AIM score will be the sum of the 4 item responses ranging from 4-20. Higher AIM scores indicate higher acceptability. Acceptability of SNaP by PWID will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. Only the first acceptability assessment collected for a participant is reported.
Mean Acceptability Score of SNaP by Test Site Staff (OADRI)	24 months after implementation of SNaP in a clinic	Acceptability is the perception that the SNaP intervention is agreeable, palatable, or satisfactory to test site staff. Acceptability among site staff will be assessed using the Ottawa Acceptability of Decision Rules Instrument (OADRI), a 12-item scale, staff and client acceptability of an innovation in a clinic setting. Eight of the 12 items were included in the assessment, excluding 4 irrelevant questions for the study setting. Scores range from 8-48. Higher OADRI scores indicate higher acceptability. Acceptability of SNaP by Test Site Staff will be assessed at 12 and 24 months after SNaP implementation in a clinic. Only the 24-month assessment is reported.
Incremental Cost-Effectiveness Ratio of SA Compared to TA for SNaP Implementation	Up to 24 months after SNaP implementation in a clinic.	The incremental cost per incremental ART uptake, comparing TA to SA, measured as: The difference in costs of implementing SNaP in TA compared to SA sites divided by the difference in ART uptake in TA compared to SA sites.; Incremental cost-effectiveness of SNaP implementation will be assessed up to 24 months after SNaP implementation in a clinic.
Percent of PWID Alive and Remaining on ART	Up to 24 months after SNaP implementation in a clinic	Percent of PWID alive and on ART among the PWID who initiated SNaP, measured through medical records and/or self-report of consenting PWID. Percent of PWID alive and remaining on ART will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. Only the first assessment collected for a participant is reported.
Percent of Clinics Continuing to Offer SNaP After Completion of Study Activities	Up to 37 months after SNaP implementation in a clinic	Sustainment of SNaP at the test sites is assessed by this measure.; Sustainment of SNaP is defined as the % of clinics continuing to offer SNaP after completion of study activities, based on survey of clinic staff; Sustainment of SNaP will be assessed up to 37 months after SNaP implementation in a clinic.

Trial Locations

Locations (1)

Hanoi Medical University; 🇻🇳 Hanoi, Vietnam