Drug Use, HIV Infections
Conditions
Keywords
Cluster randomized controlled implementation trial, Intervention mapping, People who inject drugs, HIV/AIDS, Systems navigation, Psychosocial counseling, Vietnam
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.
Interventions
OTHERStandard Approach (SA)
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.
OTHERTailored Approach (TA)
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Ohio State University
Johns Hopkins University
Hanoi Medical University
Vietnam Administration for HIV/AIDS Control
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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.) |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
| 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. |
| 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. |
Countries
Vietnam
Participant flow
Recruitment details
This study assessed implementation of the SNaP intervention at 42 HIV Test Sites for 24 months. HIV test site directors and staff were recruited and enrolled prior to SNaP implementation. PWID participants were recruited and enrolled throughout the 24 months of SNaP implementation.
Participants by arm
| Arm | Count |
|---|---|
| Standard Approach (SA) The Standard Approach is a one-size-fits-all multifaceted implementation strategy that was systematically developed using Intervention Mapping.
Standard Approach (SA): 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. | 359 |
| 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.
Tailored Approach (TA): 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. | 364 |
| Total | 723 |
Baseline characteristics
| Characteristic | Standard Approach (SA) | Total | Tailored Approach (TA) |
|---|---|---|---|
| Age, Continuous | 34 years | 35 years | 37 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 359 Participants | 723 Participants | 364 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 359 Participants | 723 Participants | 364 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Vietnam | 359 Participants | 723 Participants | 364 Participants |
| Sex: Female, Male Female | 40 Participants | 71 Participants | 31 Participants |
| Sex: Female, Male Male | 319 Participants | 652 Participants | 333 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 23 / 359 | 42 / 364 | 0 / 136 | 0 / 141 |
| other Total, other adverse events | 0 / 359 | 0 / 364 | 0 / 136 | 0 / 141 |
| serious Total, serious adverse events | 0 / 359 | 0 / 364 | 0 / 136 | 0 / 141 |
Outcome results
Primary
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.)
Time frame: Measured over 26 months after SNaP implementation in a clinic
Population: 1 clinic in each arm did not have audio recordings available to calculate the session quality score. Thus, determining a Fidelity score was not possible.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Approach (SA) | Fidelity to SNaP Intervention Procedures | 114.1 score on a scale | Standard Deviation 13.5 |
| Tailored Approach (TA) | Fidelity to SNaP Intervention Procedures | 151.4 score on a scale | Standard Deviation 21.4 |
95% CI: [26.5, 48.1]
Primary
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.
Time frame: Medical record reviews conducted within 6 months after enrollment; self-report: 6-12 months after enrollment among those who initiated SNaP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Approach (SA) | Percent of PWID Who Initiated ART | 98.6 percentage of participants |
| Tailored Approach (TA) | Percent of PWID Who Initiated ART | 99.5 percentage of participants |
95% CI: [2, 2.1]
Secondary
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.
Time frame: Up to 24 months after SNaP implementation in a clinic.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Approach (SA) | Incremental Cost-Effectiveness Ratio of SA Compared to TA for SNaP Implementation | 25,872.75 USD/Incremental Person Initiating ART |
Secondary
Mean Acceptability Score of SNaP by PWID (AIM)
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.
Time frame: Up to 24 months after SNap implementation in a clinic
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Approach (SA) | Mean Acceptability Score of SNaP by PWID (AIM) | 16.7 score on a scale | Standard Deviation 1.1 |
| Tailored Approach (TA) | Mean Acceptability Score of SNaP by PWID (AIM) | 16.8 score on a scale | Standard Deviation 1.3 |
95% CI: [-0.2, 0.4]
Secondary
Mean Acceptability Score of SNaP by Test Site Staff (OADRI)
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.
Time frame: 24 months after implementation of SNaP in a clinic
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Approach (SA) | Mean Acceptability Score of SNaP by Test Site Staff (OADRI) | 37.7 score on a scale | Standard Deviation 5.1 |
| Tailored Approach (TA) | Mean Acceptability Score of SNaP by Test Site Staff (OADRI) | 37.1 score on a scale | Standard Deviation 7 |
95% CI: [-3.1, 2]
Secondary
Percent 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.
Time frame: Up to 37 months after SNaP implementation in a clinic
Population: HIV Test Site Directors and Staff who completed a sustainment survey 6-10 months following the completion of the SNaP activities at each site.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Approach (SA) | Percent of Clinics Continuing to Offer SNaP After Completion of Study Activities | 33 % of Clinics |
| Tailored Approach (TA) | Percent of Clinics Continuing to Offer SNaP After Completion of Study Activities | 57 % of Clinics |
Secondary
Percent of PWID Alive and Remaining on ART
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.
Time frame: Up to 24 months after SNaP implementation in a clinic
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Approach (SA) | Percent of PWID Alive and Remaining on ART | 74.5 percentage of participants |
| Tailored Approach (TA) | Percent of PWID Alive and Remaining on ART | 84.3 percentage of participants |
95% CI: [-1.5, 13.8]
Secondary
Percent of PWID on Medication-Assisted Treatment (MAT)
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.
Time frame: Up to 24 months after SNaP implementation in a clinic
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Approach (SA) | Percent of PWID on Medication-Assisted Treatment (MAT) | 10.9 percentage of participants |
| Tailored Approach (TA) | Percent of PWID on Medication-Assisted Treatment (MAT) | 12.8 percentage of participants |
95% CI: [-6.9, 10]
Secondary
Percent of PWID Who Are Virally Suppressed
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.
Time frame: Up to 24 months after implementation of SNaP in a clinic
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Approach (SA) | Percent of PWID Who Are Virally Suppressed | 43.0 percentage of participants |
| Tailored Approach (TA) | Percent of PWID Who Are Virally Suppressed | 59.3 percentage of participants |
95% CI: [5, 26.5]
Secondary
Percent of 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. Only the 24-month assessment is reported.
Time frame: Up to 24 months after implementation of SNaP in a clinic
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Approach (SA) | Percent of PWID Who Were Contacted and Participated in SNaP | 100 percentage of participants |
| Tailored Approach (TA) | Percent of PWID Who Were Contacted and Participated in SNaP | 100 percentage of participants |