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Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation

Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation (WHAT-IF?)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02907944
Acronym
WHAT-IF?
Enrollment
3838
Registered
2016-09-20
Start date
2016-09-30
Completion date
2021-09-30
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance-related Disorders

Brief summary

Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use disorders (herein refered to as addiction treatments) were routinely provided in HIV clinics? Implementation Facilitation is an established strategy to increase the uptake of evidence-based treatments. Our goal is to evaluate the impact of Implementation Facilitation on the use of addiction treatments in four large HIV clinics. The purpose of the WHAT-IF study is: Aim 1. Among key stakeholders, to use quantitative and qualitative (mixed) methods to identify the site-specific evidence, context and facilitation-related barriers and facilitators to the integration of addiction treatments to help tailor an Implementation Facilitation for each clinic. Aim 2. To evaluate the impact of Implementation Facilitation on: 2a: Organizational readiness to deliver addiction treatments 2b: Provider readiness to deliver addiction treatments 2c: Provision of addiction treatments 2d: Changes in organizational models of care used to deliver addiction treatments Aim 3. To evaluate the impact of Implementation Facilitation on antiretroviral therapy receipt, HIV viral suppression, VACS Index, and retention in HIV care among patients eligible for addiction treatment.

Detailed description

The Working with HIV clinics to adopt Addiction Treatments using Implementation Facilitation (WHAT IF?) study will evaluate the impact of Implementation Facilitation on the adoption of addiction treatment services in four HIV clinics. We will use a stepped wedge design . The primary comparison is of the change that occurs from the pre-implementation period to two post-implementation periods, the initial six months (evaluation) and the following six months (maintenance). This proposal will consist of three main components in each of four clinics: 1) formative evaluation with key stakeholders at each site to guide and refine the Implementation Facilitation, 2) conduct of the Implementation Facilitation and 3) an evaluation of the impact of the Implementation Facilitation on organization and provider-level readiness, provision of addiction treatments, and HIV outcomes.

Interventions

Implementation Facilitation is an evidence-based strategy tailored to the specific needs of the clinic, designed to increase uptake of evidence based treatments for tobacco, alcohol and opioid use disorders. Will include provider education and academic detailing. * External Facilitator: Outside content expert who assists site * Local Champion: Site stakeholder who promotes change * Provider Education and Academic Detailing: Provision of unbiased peer education * Stakeholder Engagement: Aligning goals of implementation and those impacted * Tailor Program to Site: Addressing site specific needs based on Aim 1 * Performance Monitoring and Feedback: Assess implementation of screening and treatment efforts and inform site of results * Formative Evaluation: Quant. and qual. determination of impact * Establish a Learning Collaborative: Shared learning opportunities tailored to stakeholders * Program Marketing: Increase attention to availability of on-site addiction treatment services

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient inclusion criteria: * HIV-infected * Receiving HIV care in the index clinic * Age \>18 years old * Meets criteria for lifetime or current tobacco, alcohol and/or opioid use disorder regardless of addiction treatment status * Able to provide verbal informed consent Staff inclusion criteria: * Employed at participating HIV clinic for at least 6 months * Able to provide verbal informed consent. Payer/health insurance provider inclusion criteria: * Employed at an organization or agency that provides funding for medical services for HIV-infected individuals for at least 6 months. * Able to provide verbal informed consent.

Exclusion criteria

* Unable to provide verbal informed consent

Design outcomes

Primary

MeasureTime frameDescription
Change in Provision of Addiction TreatmentsBaseline, 6 monthsStudy team will use the electronic health record (EHR) to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 6 month Intervention period.

Secondary

MeasureTime frameDescription
Antiretroviral Therapy (ART) Receipt6 monthsART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record.
Viral Suppression6 monthsViral suppression, will be defined as HIV RNA \<200 copies/mL at last test closest to the time of data extraction, consistent with Department of Health and Human Services (DHHS) guidelines. Although current limits of detection are lower, this cutoff allows for low-level blips that have no clinical significance.
VACS Index6 monthsThe Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. VACS Index: minimum value: 0; maximum value: 164- a higher score means a worse outcome.
Retention in HIV Care6 monthsRetention in HIV care, per DHHS guidelines uses a 24-month measurement period. It is defined as at least one HIV medical care visit in each 6-month period, with a minimum of 60 days between the first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. This measure has good agreement with the Institute of Medicine indicator for retention in care and is an independent predictor of mortality. We will evaluate whether patients have had at least 1 visit in the 6-month period prior to time of data extraction.
Organizational Readiness6 monthsInvestigators will use the ORCA to measure factors impacting the provision of addiction treatments. This 15-minute survey is based on the PARiHS framework and asks the respondent to rate local factors related to evidence, context and facilitation on a 5-point Likert scale from strongly disagree to strongly agree. Facilitation questions will be omitted from the pre-implementation assessment since this part of the intervention and will not have taken place. The score has a range from 1 to 5 where a higher score indicates higher readiness.
Provider Readiness6 monthsInvestigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention. The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.
Provider Readiness:12 monthsInvestigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention.185 The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.

Countries

United States

Participant flow

Recruitment details

At each of the 6 month assessment stages, the numbers fluctuate based on the number of patients identified in the electronic health record (EHR) and the number of clinicians and staff that completed each survey. The numbers at each stage are part of a sliding cohort where direct follow up with patients and clinicians longitudinally is not part of the design. Assessment of patients using EHR began 6 months prior to the assessment of clinicians and staff using surveys.

Participants by arm

ArmCount
Patient Characteristics
Presented are the characteristics of patients across 4 clinics in the control (baseline) phase in the implementation facilitation design.
3,647
Patient Characteristics
Presented are the characteristics of patients across 4 clinics in the control (baseline) phase in the implementation facilitation design.
4
Clinician/Staff Characteristics
Presented are the characteristics of clinician/staff participants across 4 clinics in the control (baseline) phase in the implementation facilitation design.
70
Clinician/Staff Characteristics
Presented are the characteristics of clinician/staff participants across 4 clinics in the control (baseline) phase in the implementation facilitation design.
4
Total3,725

Baseline characteristics

CharacteristicPatient CharacteristicsClinician/Staff CharacteristicsTotal
Age, Continuous49 years
STANDARD_DEVIATION 12
58 years
STANDARD_DEVIATION 41
NA years
CD4 cell count categorized (cells/μL)
100-199
154 Participants154 Participants
CD4 cell count categorized (cells/μL)
200-349
336 Participants336 Participants
CD4 cell count categorized (cells/μL)
350-499
480 Participants480 Participants
CD4 cell count categorized (cells/μL)
<50
31 Participants31 Participants
CD4 cell count categorized (cells/μL)
>500
1697 Participants1697 Participants
CD4 cell count categorized (cells/μL)
50-99
42 Participants42 Participants
CD4 cell count categorized (cells/μL)
Missing
907 Participants907 Participants
Clinician (physicians, physician assistant, nurse practitioner)
No
36 Participants36 Participants
Clinician (physicians, physician assistant, nurse practitioner)
Yes
34 Participants34 Participants
Completed Visits at Baseline2 Clinic Visits2 Clinic Visits
Detectable HIV viral load (>200 copies/mL)
Missing
548 Participants548 Participants
Detectable HIV viral load (>200 copies/mL)
No
2774 Participants2774 Participants
Detectable HIV viral load (>200 copies/mL)
Yes
325 Participants325 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
781 Participants12 Participants793 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2859 Participants52 Participants2911 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
7 Participants6 Participants13 Participants
Ever prescribed medications to treat tobacco use disorder32 Participants32 Participants
Ever prescribed medications to treat unhealthy alcohol use14 Participants14 Participants
Ever prescribed oral or injectable (eg, Vivitrol) naltrexone to treat opioid use disorder5 Participants5 Participants
Ever provided counseling to treat opioid use disorder32 Participants32 Participants
Ever provided counseling to treat tobacco use disorder34 Participants34 Participants
Ever provided counseling to treat unhealthy alcohol use34 Participants34 Participants
Hepatitis C virus infection
Missing
53 Participants53 Participants
Hepatitis C virus infection
No
3072 Participants3072 Participants
Hepatitis C virus infection
Yes
522 Participants522 Participants
Hold a waiver that allows buprenorphine (eg, Suboxone) prescribing11 Participants11 Participants
Prescribed Antiretroviral Therapy
No
217 Participants217 Participants
Prescribed Antiretroviral Therapy
Yes
3430 Participants3430 Participants
Private or commercial insurance
Missing
1182 Participants1182 Participants
Private or commercial insurance
No
1480 Participants1480 Participants
Private or commercial insurance
Yes
985 Participants985 Participants
Public insurance
Missing
1182 Participants1182 Participants
Public insurance
No
740 Participants740 Participants
Public insurance
Yes
1725 Participants1725 Participants
Race/Ethnicity, Customized
Race
Asian
19 Participants6 Participants25 Participants
Race/Ethnicity, Customized
Race
Black
1814 Participants10 Participants1824 Participants
Race/Ethnicity, Customized
Race
Missing
7 Participants1 Participants8 Participants
Race/Ethnicity, Customized
Race
Other
689 Participants8 Participants697 Participants
Race/Ethnicity, Customized
Race
White
1118 Participants45 Participants1163 Participants
Region of Enrollment
United States
3647 participants70 participants3717 participants
Self-Pay
Missing
1182 Participants1182 Participants
Self-Pay
No
2444 Participants2444 Participants
Self-Pay
Yes
21 Participants21 Participants
Sex: Female, Male
Female
1407 Participants51 Participants1458 Participants
Sex: Female, Male
Male
2240 Participants19 Participants2259 Participants
Time per week spent working at HIV clinic31 hours31 hours
Time working at clinic7 years
STANDARD_DEVIATION 8
7 years
STANDARD_DEVIATION 8

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Change in Provision of Addiction Treatments

Study team will use the electronic medical record to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 12 month Evaluation period.

Time frame: Baseline, 12 months

Population: Unique patients assessed across the two time points by disorder type.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Opioid Use Disorder PatientsChange in Provision of Addiction TreatmentsControl (Baseline)66 Participants
Opioid Use Disorder PatientsChange in Provision of Addiction TreatmentsEvaluation (12 months)38 Participants
Alcohol Use Disorder PatientsChange in Provision of Addiction TreatmentsEvaluation (12 months)15 Participants
Alcohol Use Disorder PatientsChange in Provision of Addiction TreatmentsControl (Baseline)20 Participants
Tobacco Use DisorderChange in Provision of Addiction TreatmentsControl (Baseline)268 Participants
Tobacco Use DisorderChange in Provision of Addiction TreatmentsEvaluation (12 months)190 Participants
p-value: 0.5995% CI: [0.81, 1.45]Generalized Estimating Equation
p-value: 0.1195% CI: [0.88, 3.55]Generalized Estimating Equation
p-value: 0.00595% CI: [1.09, 1.66]Generalized Estimating Equation
Primary

Change in Provision of Addiction Treatments

Study team will use the electronic health record (EHR) to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 6 month Intervention period.

Time frame: Baseline, 6 months

Population: Unduplicate count of participants from control stage to intervention stage.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Opioid Use Disorder PatientsChange in Provision of Addiction TreatmentsControl (Baseline)66 Participants
Opioid Use Disorder PatientsChange in Provision of Addiction TreatmentsIntervention (6 months)33 Participants
Alcohol Use Disorder PatientsChange in Provision of Addiction TreatmentsControl (Baseline)20 Participants
Alcohol Use Disorder PatientsChange in Provision of Addiction TreatmentsIntervention (6 months)15 Participants
Tobacco Use DisorderChange in Provision of Addiction TreatmentsControl (Baseline)268 Participants
Tobacco Use DisorderChange in Provision of Addiction TreatmentsIntervention (6 months)183 Participants
p-value: 0.5595% CI: [0.82, 1.45]Generalized Estimating Equation
p-value: 0.0995% CI: [0.92, 3.37]Generalized Estimating Equation
p-value: 0.00195% CI: [1.14, 1.71]Generalized Estimating Equation
Secondary

Antiretroviral Therapy (ART) Receipt

ART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record.

Time frame: 12 months

Population: All patients monitored across all (multiple) control and evaluation periods.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Opioid Use Disorder PatientsAntiretroviral Therapy (ART) Receipt4106 Participants
Alcohol Use Disorder PatientsAntiretroviral Therapy (ART) Receipt3508 Participants
Secondary

Antiretroviral Therapy (ART) Receipt

ART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record.

Time frame: 6 months

Population: All those included in the multiple control and intervention phases across sites.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Opioid Use Disorder PatientsAntiretroviral Therapy (ART) Receipt4106 Participants
Alcohol Use Disorder PatientsAntiretroviral Therapy (ART) Receipt3547 Participants
Secondary

Organizational Readiness

Investigators will use the ORCA to measure factors impacting the provision of addiction treatments. This 15-minute survey is based on the PARiHS framework and asks the respondent to rate local factors related to evidence, context and facilitation on a 5-point Likert scale from strongly disagree to strongly agree. Facilitation questions will be omitted from the pre-implementation assessment since this part of the intervention and will not have taken place. The score has a range from 1 to 5 where a higher score indicates higher readiness.

Time frame: 6 months

Population: Unduplicated count of survey respondents for the intervention period.

ArmMeasureValue (MEAN)
Opioid Use Disorder PatientsOrganizational Readiness4.46 units on a scale
Alcohol Use Disorder PatientsOrganizational Readiness4.14 units on a scale
Tobacco Use DisorderOrganizational Readiness4.31 units on a scale
Secondary

Organizational Readiness

Investigators will use the ORCA to measure factors impacting the provision of addiction treatments. This 15-minute survey is based on the PARiHS framework and asks the respondent to rate local factors related to evidence, context and facilitation on a 5-point Likert scale from strongly disagree to strongly agree. Facilitation questions will be omitted from the pre-implementation assessment since this part of the intervention and will not have taken place. The score has a range from 1 to 5 where a higher score indicates higher readiness.

Time frame: 12 months

Population: Unduplicated count of survey respondents for the maintenance period.

ArmMeasureValue (MEAN)
Opioid Use Disorder PatientsOrganizational Readiness4.37 units on a scale
Alcohol Use Disorder PatientsOrganizational Readiness4.05 units on a scale
Tobacco Use DisorderOrganizational Readiness4.13 units on a scale
Secondary

Provider Readiness

Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention. The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.

Time frame: 6 months

Population: Unduplicated count of survey respondents for the intervention period.

ArmMeasureValue (MEAN)
Opioid Use Disorder PatientsProvider Readiness6.75 units on a scale
Alcohol Use Disorder PatientsProvider Readiness6.22 units on a scale
Tobacco Use DisorderProvider Readiness7.24 units on a scale
Secondary

Provider Readiness:

Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention.185 The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.

Time frame: 12 months

Population: Unduplicated count of survey respondents for the maintenance period.

ArmMeasureValue (MEAN)
Opioid Use Disorder PatientsProvider Readiness:7.28 units on a scale
Alcohol Use Disorder PatientsProvider Readiness:7.16 units on a scale
Tobacco Use DisorderProvider Readiness:7.50 units on a scale
Secondary

Retention in HIV Care

Retention in HIV care, per DHHS guidelines uses a 24-month measurement period. It is defined as at least one HIV medical care visit in each 6-month period, with a minimum of 60 days between the first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. This measure has good agreement with the Institute of Medicine indicator for retention in care and is an independent predictor of mortality. We will evaluate whether patients have had at least 1 visit in the 6-month period prior to time of data extraction.

Time frame: 6 months

Population: Patients identified at the control period to follow up with at the end of the intervention period.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Opioid Use Disorder PatientsRetention in HIV Care3567 Participants
Secondary

Retention in HIV Care

Retention in HIV care, per DHHS guidelines uses a 24-month measurement period. It is defined as at least one HIV medical care visit in each 6-month period, with a minimum of 60 days between the first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. This measure has good agreement with the Institute of Medicine indicator for retention in care and is an independent predictor of mortality. We will evaluate whether patients have had at least 1 visit in the 6-month period prior to time of data extraction.

Time frame: 12 months

Population: Patients identified at the control period to follow up with at the end of the evaluation period.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Opioid Use Disorder PatientsRetention in HIV Care3450 Participants
Secondary

VACS Index

The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. VACS Index: minimum value: 0; maximum value: 164- a higher score means a worse outcome.

Time frame: 12 months

Population: Unduplicated count of survey respondents at each administration.

ArmMeasureValue (MEAN)
Opioid Use Disorder PatientsVACS Index23.53 units on a scale
Alcohol Use Disorder PatientsVACS Index25.12 units on a scale
Secondary

VACS Index

The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. VACS Index: minimum value: 0; maximum value: 164- a higher score means a worse outcome.

Time frame: 6 months

Population: Unduplicated count of survey respondents at each administration.

ArmMeasureValue (MEAN)
Opioid Use Disorder PatientsVACS Index23.53 units on a scale
Alcohol Use Disorder PatientsVACS Index24.54 units on a scale
Secondary

Viral Suppression

Viral suppression, will be defined as HIV RNA \<200 copies/mL at last test closest to the time of data extraction, consistent with Department of Health and Human Services (DHHS) guidelines. Although current limits of detection are lower, this cutoff allows for low-level blips that have no clinical significance.

Time frame: 12 months

Population: All patients monitored across all control (multiple) and evaluation periods.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Opioid Use Disorder PatientsViral Suppression3849 Participants
Alcohol Use Disorder PatientsViral Suppression2830 Participants
Secondary

Viral Suppression

Viral suppression, will be defined as HIV RNA \<200 copies/mL at last test closest to the time of data extraction, consistent with Department of Health and Human Services (DHHS) guidelines. Although current limits of detection are lower, this cutoff allows for low-level blips that have no clinical significance.

Time frame: 6 months

Population: All patients monitored across all control (multiple) and intervention periods.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Opioid Use Disorder PatientsViral Suppression3849 Participants
Alcohol Use Disorder PatientsViral Suppression2880 Participants

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026