HivNCT05241990
Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care
A study testing Practice Facilitation and Alcohol Stepped Care in people with Hiv and Alcohol Use, Unspecified, run by Johns Hopkins University at 3 sites in United States.
Trial summary
Despite availability of evidence-based alcohol reduction interventions (EBI), unhealthy alcohol use remains a barrier to HIV medication adherence, viral suppression and retention in HIV care and consequently HIV treatment as prevention (TASP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Alcohol Use, Unspecified
- What is being tested?
- Practice Facilitation and Alcohol Stepped Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Feb 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Confirmed to be clinic staff (clinical or administrative roles).
- English speaking
- Cognitively able to complete required survey or interview activities.
- Confirmed to be a person with HIV (PWH) receiving HIV care and participating in CNICS at one of the three clinic sites
- Scoring AUDIT-C ≥3 for women or ≥4 for men, transgender women or men indicating unhealthy alcohol use.
Show all 9Show fewer
- Age ≥ 18 years old.
- English speaking.
- Cognitively able to participate in stepped care for unhealthy alcohol use.
Who cannot join
- Unable to speak English
- Scoring AUDIT-C <3 for women or <4 for men or <4 for transgender women or men
- Age < 18 years old
- Participants cognitively unable to participate in the stepped care for unhealthy alcohol use.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Fenway Community Health
Boston, Massachusetts, 02114
Justin Hinchey, 617-643-0385, jhinchey@fenwayhealth.org
Conall O'Cleirigh, 617-643-0385
- Not yet recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599-7215
Sonia Napravnik, 919-966-3875, sonia_napravnik@med.unc.edu
- Recruiting
University of California, San Diego
San Diego, California, 92103
Vivian Maldonado, 619-543-3995, vmaldonado@ucsd.edu
Edward C Cachay, 6195433995
About this study
Official title: A Hybrid Type III Implementation Trial Testing Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care
Despite availability of evidence-based alcohol reduction interventions (EBI), unhealthy alcohol use remains a barrier to HIV medication adherence, viral suppression and retention in HIV care and consequently HIV treatment as prevention (TASP). Guided by complementary implementation and evaluation frameworks-the Consolidated Framework for Implementation Research (CFIR) and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance), The investigators will conduct a Hybrid Type 3 effectiveness-implementation evaluating implementation trial testing whether practice facilitation, an evidence-based multifaceted implementation strategy increases reach, adoption, implementation, and maintenance of stepped care for unhealthy alcohol use in three Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) HIV clinics located in Boston, San Diego, and Chapel Hill. The investigators will secondarily test whether practice facilitation is associated with decreased unhealthy alcohol use, and improved Antiretroviral Therapy (ART) adherence and viral suppression at the patient level. In practice facilitation, a practice coach will offer tools, resources, hands-on guidance, and content expertise to assist sites in offering a stepped care model of alcohol treatment to patients with unhealthy alcohol use. Stepped care will include brief intervention, cognitive behavioral therapy, and alcohol pharmacotherapy. The practice facilitation intervention will be rolled out sequentially across sites. There will be three phases at each site: pre-implementation planning, implementation with formative evaluation, and post-implementation summative evaluation. Using mixed methods, The investigators specifically propose to meet the following specific aims: (Aim 1) Tailor the practice facilitation intervention to each site using mixed methods (pre-implementation); (Aim 2a) Determine the effects of practice facilitation on implementation of stepped care (primary) and alcohol use and HIV-related outcomes (secondary) using interrupted time series analysis with synthetic controls (summative evaluation); (Aim 2b) Determine the effect of practice facilitation on reach, adoption, and maintenance of evidence-based alcohol treatment using mixed methods (formative evaluation); and (Aim 3) Describe barriers and facilitators to implementation of alcohol-related interventions at each site to describe maintenance and inform widespread sustainable implementation.
- Conditions
- Hiv, Alcohol Use, Unspecified
- Being tested
- Practice Facilitation, Alcohol Stepped Care
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice FacilitationBehavioural
A practice coach will offer tools, resources, hands-on guidance, and content expertise to assist sites in offering a stepped care model of alcohol treatment to patients with unhealthy alcohol use.
Alcohol Stepped CareBehavioural
Based on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Stepped Care | Experimental | Based on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder Receives: Behavioral: Practice Facilitation; Behavioral: Alcohol Stepped Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation as assessed by the percent of patients receiving an alcohol intervention
Percent of patients receiving an alcohol intervention since their last visit among all eligible individuals.
Measured: 12 months
Secondary outcomes (3)
Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C)
AUDIT-C Score of <3 in women and <4 in men indicating reduction to lower risk use
Measured: Baseline and 12 months
Antiretroviral therapy adherence as assessed by a self report on a visual analog scale
Self report of >90% adherence on visual analog scale with higher scores indicating greater adherence
Measured: 12 months
Viral Suppression as assessed by HIV-RNA copies
Viral Suppression will assessed by HIV-RNA copies. HIV-RNA <200 copies indicates viral suppression.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start15 Feb 2023
- Primary completion15 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Washington, University of Alabama at Birmingham, Fenway Community Health, University of North Carolina, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Geetanjali Chander, MD, Principal investigator, Johns Hopkins UniversityBetsy McCaul, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241990
- Sponsor's protocol ID
- IRB00303116
- Other IDs
- P01AA029544
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per NIAAA policy, data will be deposited in the NIAAA Data Archive (NIAAADA), a data repository in the National Institute of Mental Health (NIMH) Data Archive (NDA)
Publications
Chander G, Batey DS, Austin EJ, Bentley MJ, Cachay ER, Crane HM, Farel C, Fleming J, Grelotti DJ, Hutton HE, Idrisov B, Mathena J, McCaul ME, Napravnik S, O'Clerigh C, Lau B, Williams EC. Practice facilitation to implement stepped care for unhealthy alcohol use in HIV clinics: study protocol for a type III hybrid effectiveness-implementation study. Addict Sci Clin Pract. 2026 Mar 31;21(1):34. doi: 10.1186/s13722-026-00662-6.
PubMed 41918133
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Type III Implementation Trial Testing Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care
- ClinicalTrials.gov ID
- NCT05241990
- Acronym / sponsor ID
- IRB00303116
- Conditions
- Hiv, Alcohol Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Washington, University of Alabama at Birmingham, Fenway Community Health, University of North Carolina, University of California, San Diego
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite availability of evidence-based alcohol reduction interventions (EBI), unhealthy alcohol use remains a barrier to HIV medication adherence, viral suppression and retention in HIV care and consequently HIV treatment as prevention (TASP). Guided by complementary implementation and evaluation frameworks-the Consolidated Framework for Implementation Research (CFIR) and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance), The investigators will conduct a Hybrid Type 3 effectiveness-implementation evaluating implementation trial testing whether practice facilitation, an evidence-based multifaceted implementation strategy increases reach, adoption, implementation, and maintenance of stepped care for unhealthy alcohol use in three Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) HIV clinics located in Boston, San Diego, and Chapel Hill. The investigators will secondarily test whether practice facilitation is associated with decreased unhealthy alcohol use, and improved Antiretroviral Therapy (ART) adherence and viral suppression at the patient level. In practice facilitation, a practice coach will offer tools, resources, hands-on guidance, and content expertise to assist sites in offering a stepped care model of alcohol treatment to patients with unhealthy alcohol use. Stepped care will include brief intervention, cognitive behavioral therapy, and alcohol pharmacotherapy. The practice facilitation intervention will be rolled out sequentially across sites. There will be three phases at each site: pre-implementation planning, implementation with formative evaluation, and post-implementation summative evaluation. Using mixed methods, The investigators specifically propose to meet the following specific aims: (Aim 1) Tailor the practice facilitation intervention to each site using mixed methods (pre-implementation); (Aim 2a) Determine the effects of practice facilitation on implementation of stepped care (primary) and alcohol use and HIV-related outcomes (secondary) using interrupted time series analysis with synthetic controls (summative evaluation); (Aim 2b) Determine the effect of practice facilitation on reach, adoption, and maintenance of evidence-based alcohol treatment using mixed methods (formative evaluation); and (Aim 3) Describe barriers and facilitators to implementation of alcohol-related interventions at each site to describe maintenance and inform widespread sustainable implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alcohol Stepped Care | Experimental | Behavioral: Practice Facilitation, Behavioral: Alcohol Stepped CareBased on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years old
- Confirmed to be clinic staff (clinical or administrative roles).
- English speaking
- Cognitively able to complete required survey or interview activities.
- Confirmed to be a person with HIV (PWH) receiving HIV care and participating in CNICS at one of the three clinic sites
Key exclusion criteria (4 listed)
- Unable to speak English
- Scoring AUDIT-C <3 for women or <4 for men or <4 for transgender women or men
- Age < 18 years old
- Participants cognitively unable to participate in the stepped care for unhealthy alcohol use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice FacilitationA practice coach will offer tools, resources, hands-on guidance, and content expertise to assist sites in offering a stepped care model of alcohol treatment to patients with unhealthy alcohol use. | Behavioural | Alcohol Stepped Care |
| Alcohol Stepped CareBased on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder | Behavioural | Alcohol Stepped Care |
Primary outcome
Implementation as assessed by the percent of patients receiving an alcohol intervention
Time frame: 12 months
Percent of patients receiving an alcohol intervention since their last visit among all eligible individuals.
3 secondary outcomes
Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C)
Time frame: Baseline and 12 months
Antiretroviral therapy adherence as assessed by a self report on a visual analog scale
Time frame: 12 months
Viral Suppression as assessed by HIV-RNA copies
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Derived from this study: PubMed 41918133Chander G, Batey DS, Austin EJ, Bentley MJ, Cachay ER, Crane HM, Farel C, Fleming J, Grelotti DJ, Hutton HE, Idrisov B, Mathena J, McCaul ME, Napravnik S, O'Clerigh C, Lau B, Williams EC. Practice facilitation to implement stepped care for unhealthy alcohol use in HIV clinics: study protocol for a type III hybrid effectiveness-implementation study. Addict Sci Clin Pract. 2026 Mar 31;21(1):34. doi: 10.1186/s13722-026-00662-6.
- Individual participant dataSharing planned: Yes. Per NIAAA policy, data will be deposited in the NIAAA Data Archive (NIAAADA), a data repository in the National Institute of Mental Health (NIMH) Data Archive (NDA)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Geetanjali Chander, MD principal investigator
Johns Hopkins University
Betsy McCaul, PhD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Facilitation and Alcohol Stepped Care in people with Hiv and Alcohol Use, Unspecified, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JoAnna Mathena (410-955-9534, jmathen5@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation as assessed by the percent of patients receiving an alcohol intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.