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

Study Overview
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Brief Summary
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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
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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). 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.

Official Title
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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

Conditions
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HIV Infections, Drug Use

Intervention / Treatment
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* Other: Standard Approach (SA)
* Other: Tailored Approach (TA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Approach (SA)<br>The Standard Approach is a one-size-fits-all multifaceted implementation strategy that was systematically developed using Intervention Mapping. | Other: Standard Approach (SA)<br>* 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.<br>|
| Experimental: Tailored Approach (TA)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| % PWID Who Initiated ART | % of PWID who initiated 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % PWID Who Were Contacted and Participated in SNaP | 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. | Up to 24 months after implementation of SNaP in a clinic | 
| Acceptability of SNaP by PWID | 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. 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. | Up to 24 months after SNap implementation in a clinic. | 
| Acceptability of SNaP by Test Site Staff | 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. 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. | Up to 24 months after implementation of SNaP in a clinic | 
| % PWID Who Are Virally Suppressed | % 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.) % of PWID who are virally suppressed will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. | Up to 24 months after implementation of SNaP in a clinic. | 
| % PWID on Medication-Assisted Treatment (MAT) | % 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. % of PWID on MAT will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. | Up to 24 months after SNaP implementation in a clinic | 
| Incremental Cost-Effectiveness Ratio of SA Compared to TA for SNaP Implementation | 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. | Up to 24 months after SNaP implementation in a clinic. | 
| % of PWID alive and remaining on ART | of PWID alive and on ART among the PWID who initiated SNaP, measured through medical records and/or self-report of consenting PWID of PWID alive and remaining on ART will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. | Up to 24 months after SNaP implementation in a clinic. | 
| % of clinics continuing to offer SNaP after completion of study activities | 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. | Up to 37 months after SNaP implementation in a clinic | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cluster randomized controlled implementation trial, Intervention mapping, People who inject drugs, HIV/AIDS, Systems navigation, Psychosocial counseling, Vietnam