HIVNCT05887557
Multidisciplinary Low-Barrier and Mobile HIV Care to Improve Retention and Viral Suppression: Stakeholder-Engaged Design and Evaluation
A study testing Active Referral, Drop-In Multidisciplinary HIV Care and Mobile HIV Care in people with HIV, run by University of California, San Francisco at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the implementation and effectiveness of a flexible, multidisciplinary, integrated drop-in/mobile HIV care approach for people living with HIV (PLH) who are not well engaged in current care systems (i.e. scheduled HIV primary care visits). Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Active Referral, Drop-In Multidisciplinary HIV Care and Mobile HIV Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 May 2024to 31 Mar 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults or adolescents (≥15 years) living with HIV
- Most recent HIV viral load >200 copies/mL or off ART by ≥1 month by self-report
- Sub-optimal care engagement by self-report or chart history (defined as no current HIV primary care provider, no HIV primary care visit in the past 6 months, or ≥1 missed HIV primary care visit in the past 6 months)
- ≥1 major barrier to care engagement by self report or chart history (homelessness/ unstable housing, any mental health diagnosis, any illicit substance use).
Who cannot join
- Inability to give informed consent due to cognitive impairment, psychosis, or intoxication.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Cohen, MPA contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
La Clinica de la Raza, Inc
Oakland, California, 94601
Jennifer Huggans-Zapeta, NP, jhzapeta@laclinica.org
Jennifer Huggans-Zapeta, NP
- Recruiting
Lifelong Medical Care
Oakland, California, 94612
Kevin Critchlow, MD, kcritchlow@lifelongmedical.org
Kevin Critchlow, MD
- Recruiting
San Francisco AIDS Foundation
San Francisco, California, 94103
Jorge Roman, NP, jroman@sfaf.org
Jorge Roman, NP
- Recruiting
San Francisco Department of Public Health Maria X Martinez Clinic
San Francisco, California, 94105
Stephen Matzat, MD, stephen.matzat@sfdph.org
Stephen Matzat, MD
- Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Katerina Christopoulos, MD, MPH, 415-476-4082 ext. 440, Katerina.Christopoulos@ucsf.edu
Matt Hickey, MD, Matt.Hickey@ucsf.edu
About this study
Official title: Staged Low-Barrier and Mobile Care to Improve Retention and Viral Suppression in Hard-To-Reach Vulnerable People Living With HIV
The purpose of this study is to evaluate the implementation and effectiveness of a flexible, multidisciplinary, integrated drop-in/mobile HIV care approach for people living with HIV (PLH) who are not well engaged in current care systems (i.e. scheduled HIV primary care visits). The hybrid type 2 implementation-effectiveness study involves a set of implementation strategies to support implementation of the integrated drop-in/mobile HIV care approach (i.e. the evidence-informed clinical intervention) at four diverse sites in San Francisco and Alameda counties in California. Sites include an academic clinic located at a public hospital (Ward 86) and a needle exchange site (San Francisco AIDS Foundation Syringe Access Site) in San Francisco and two Federally Qualified Health Centers serving diverse patient populations in Alameda County (Trust and La Clínica). The evidence-informed clinical intervention consists of four key components: 1) active referral to care sites; 2) drop-in, multidisciplinary HIV primary care; 3) mobile HIV care; and 4) staged escalation/de-escalation of care level as needed. The study will use RE-AIM to guide evaluation, with coprimary outcomes of Reach and HIV viral suppression, and mixed methods to assess intervention Adoption, Implementation, and Maintenance. The study draws on the CFIR framework to assess site-specific implementation determinants before and after the study period. The study will undertake micro-costing using a uniform cost data collection protocol to quantify the resources needed to carry out intervention activities.
Read the detailed description
Aim 1: Formative work guided by an implementation mapping process to engage key stakeholders, finalize implementation strategies to maximize successful implementation of the evidence-informed clinical intervention, and develop site specific adaptations of the interventions along with an implementation blueprint to guide intervention delivery. Proposed implementation strategies include 1) identify and prepare referral site champions, 2) audit and feedback for referral sites, 3) build a coalition between referral and study care sites, 4) assess for readiness and identify of implementation barriers at care sites, 5) adaptation of intervention components to site-specific context, 6) develop a formal implementation blueprint to guide site-specific intervention delivery, 7) develop educational materials and conduct ongoing training at each site to support implementation fidelity, and 8) create a learning collaborative to facilitate cross-site sharing of best practices and positive peer pressure.
Aim 2: Following initial formative work, a type 2 hybrid implementation-effectiveness study will be conducted using a prospective cohort of persons referred to drop-in/mobile HIV care at one of the four participating care sites (n=400). Patients are eligible for referral to the drop-in/mobile care model if they meet the following three criteria: 1) most recent HIV viral load >200 copies/mL or off ART by ≥1 month by self-report; 2) sub-optimal care engagement by self-report or chart history (defined as no current HIV primary care provider, no HIV primary care visit in the past 6 months, or ≥ 1 missed HIV primary care visit in the past 6 months); and 3) ≥1 major barrier to care engagement by self report, chart history, or clinical assessment (homelessness/unstable housing, any mental health diagnosis, any illicit substance use). The study will compare outcomes over 12 months to two propensity score-matched control groups: 1) contemporaneous patients identified using Alameda and San Francisco Departments of Public Health (DPH) HIV surveillance data (n=400) and 2) historical patients at participating clinic sites (n=400). The evaluation will be guided by the RE-AIM implementation framework, with co-primary outcomes of Reach (≥ 1 HIV primary care visit over 12 months following referral) and Effectiveness (≥1 HIV viral load <200 copies/mL over 12 months following referral).
In Aim 3: Impact Analysis to understand and model the individual, clinic, and population-level impacts of the staged care approach, the study will use several approaches: 1) Heterogeneity and Health Equity Analysis, 2) Pathway \& Scenario Analysis, 3) Cost and Cost-effectiveness Analysis, and 4) Population-level Health Impact Modeling. Analyses will use mixed-methods to assess for whom the staged care approach worked and did not work and why. The Cost and Cost-effectiveness Analysis will estimate total program costs, costs associated with each intervention strategy, cost per person referred, cost per person engaged in each intervention strategy and cost per person engaged in optimized pathways. Observed study outcomes and scenario analysis results will be used to estimate the additional number of patients with suppressed viral load within the entire program, for each intervention strategy and for the identified optimized pathways.
- Conditions
- HIV
- Being tested
- Active Referral, Drop-In Multidisciplinary HIV Care, Mobile HIV Care, Staged Care, Identify and prepare champions at referral sites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ReferralOther
As an implementation science study, all clinical intervention components will be delivered as part of routine clinical care at participating clinical sites. Clinicians and staff at referral sites throughout San Francisco and Alameda counties (emergency departments, psychiatric emergency services, community clinics, care navigation and case management programs, and community-based services) will refer eligible patients who are out of care and are interested in linking to drop-in and/or mobile care services at one of the study sites. Clinical referrals will include basic patient information and contact/locator information to facilitate linkage to care. Referrals will be site-specific based on the site where the patient is interested in accessing care.
Drop-In Multidisciplinary HIV CareOther
Each site will independently implement a drop-in multidisciplinary site-based HIV care model. Core intervention features include drop-in care (no appointments), panel management to review clinical progress for all referred patients, and case management. Each site may include adaptations to the care model determined during Aim 1 formative work.
Mobile HIV CareOther
Each site will independently implement a mobile care model using site-specific resources. At a minimum, the mobile care team will include a clinical nurse with telemedicine (video visit) consultation with a clinician (MD/NP/PA). Mobile teams will also administer medications (including long-acting ART when available) and collect laboratory specimens (e.g. HIV viral loads)
Staged CareOther
Clinical decision rules to escalate/de-escalate care intensity will be finalized developed during Aim 1 formative work, though will be based on a combination of clinical assessment and patient preference.
Identify and prepare champions at referral sitesOther
Identify implementation champions at each referral site. Champions will receive marketing materials to promote uptake of clinical referrals to a drop-in/mobile care site by referral site providers/staff. This strategy is aimed at improving referring provider confidence in the value of referral to the care model, reduce perceived referral complexity/improve provider capability to refer, and provide positive peer pressure to promote referrals.
Audit and feedback at referral sitesOther
Investigators will provide monthly reports to implementation champions at each referral site on aggregate number of referrals and the success of referrals (proportion linking to care). This strategy is aimed at improving perceived value of the intervention and increasing provider motivation to refer.
Build a coalition among referral and clinical sitesOther
Investigators will facilitate formation of a coalition of referral and clinic sites to improve cross-site collaboration and promote positive peer pressure to improve intra-site communication and increase referrals.
Assess for readiness and identify barriersOther
Investigators will conduct patient in-depth interviews and clinical team focus group discussions to assess barriers to implementation of the clinical intervention. Findings from interviews and focus group discussions will inform site-specific implementation plans and adaptation of the intervention.
Promote adaptabilityOther
During a co-design workshop among drop-in/mobile care site teams and site-specific meetings, the study team will collectively finalize core clinical intervention components and outline site-specific adaptations (i.e. adaptable periphery of clinical intervention).
Develop a formal implementation blueprintOther
With each drop-in/mobile care team, develop site-specific implementation plan that includes defining care team and leadership structure, clinic workflow, implementation timeline, and progress measures. This process, and the resulting blueprint, will incorporate site-specific barriers and facilitators to implementation.
Develop educational materials; conduct ongoing trainingOther
Compile a manual that includes detailed description of core intervention features, planned local adaptations, and implementation guidance. We will conduct site-specific meetings to provide training on this manual. We will also conduct regular (at least monthly) meetings between the study team and the clinic site to provide technical assistance and coaching.
Create a learning collaborativeOther
Create a cross-site learning collaborative with periodic meetings and workshops throughout the study period to facilitate cross-site communication, sharing of best practices and encourage positive peer pressure to support implementation.
| Study group | Role | What they receive |
|---|---|---|
| Low-barrier drop-in and mobile care | Other | This is a single-arm trial of a set of implementation strategies to encourage uptake of drop-in and mobile HIV care for people living with HIV who experience barriers to engage in usual scheduled appointments. Receives: Other: Active Referral; Other: Drop-In Multidisciplinary HIV Care; Other: Mobile HIV Care; Other: Staged Care; Other: Identify and prepare champions at referral sites; Other: Audit and feedback at referral sites; Other: Build a coalition among referral and clinical sites; Other: Assess for readiness and identify barriers; Other: Promote adaptability; Other: Develop a formal implementation blueprint; Other: Develop educational materials; conduct ongoing training; Other: Create a learning collaborative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
Proportion of participants who access primary HIV care over the 12 months post-referral/ propensity matching.
Measured: 12 months
Number of participants with HIV viral suppression
Number of participants with any HIV viral load <200 copies/mL during the 12 months following referral/propensity matching.
Measured: 12 months
Secondary outcomes (2)
Evaluate sustained engagement in HIV care
Participants with ≥2 HIV primary care visits separated by ≥ 60 days with the most recent visit occurring between months 8-12.
Measured: 12 months
Participants with durable viral suppression
Participants with ≥2 consecutive viral load measures <200 copies/mL separated by ≥60 days with most recent viral load measured during months 8-12.
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 posted2 Jun 2023
- Study start16 May 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 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 University of California, San FranciscoThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Hybrid type 2 implementation-effectiveness Trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- La Clínica de La Raza Inc., Lifelong Medical Care, San Francisco AIDS Foundation, National Institute of Allergy and Infectious Diseases (NIAID), San Francisco Department of Public Health, Alameda County Public Health Department
- Responsible party
- Sponsor
- Investigators
- Katerina Christopoulos, MD, MPH, Principal investigator, University of California, San FranciscoMatthew Hickey, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887557
- Sponsor's protocol ID
- R01AI169667
- Other IDs
- R01AI169667
- Status last verified
- Feb 2026
- First submitted
- 15 May 2023
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified study data which includes subject demographics and study outcome measures consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards and include a descriptive data dictionary of the available dataset. The primary information sharing channel for the community will be community forums, and community advisory board meetings. Prior to dissemination, all data will be fully de-identified according to standard Safe Harbor guidelines. Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Publications
Garner BR, Bouris A, Charlebois ED, Li DH, Dakin A, Moskowitz J, Benbow N, Christopoulos K, Hickey MD, Imbert E. The Strategies Timeline and Activities Reporting Tables: Improving HIV Care by Improving the Reporting of Implementation Strategies. J Acquir Immune Defic Syndr. 2025 Apr 15;98(5S):e205-e215. doi: 10.1097/QAI.0000000000003613.
PubMed 40163072
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staged Low-Barrier and Mobile Care to Improve Retention and Viral Suppression in Hard-To-Reach Vulnerable People Living With HIV
- ClinicalTrials.gov ID
- NCT05887557
- Acronym / sponsor ID
- R01AI169667
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- La Clínica de La Raza Inc., Lifelong Medical Care, San Francisco AIDS Foundation, National Institute of Allergy and Infectious Diseases (NIAID), San Francisco Department of Public Health, Alameda County Public Health Department
- Study start
- 16 May 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Jun 2023 (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.
The purpose of this study is to evaluate the implementation and effectiveness of a flexible, multidisciplinary, integrated drop-in/mobile HIV care approach for people living with HIV (PLH) who are not well engaged in current care systems (i.e. scheduled HIV primary care visits). The hybrid type 2 implementation-effectiveness study involves a set of implementation strategies to support implementation of the integrated drop-in/mobile HIV care approach (i.e. the evidence-informed clinical intervention) at four diverse sites in San Francisco and Alameda counties in California. Sites include an academic clinic located at a public hospital (Ward 86) and a needle exchange site (San Francisco AIDS Foundation Syringe Access Site) in San Francisco and two Federally Qualified Health Centers serving diverse patient populations in Alameda County (Trust and La Clínica). The evidence-informed clinical intervention consists of four key components: 1) active referral to care sites; 2) drop-in, multidisciplinary HIV primary care; 3) mobile HIV care; and 4) staged escalation/de-escalation of care level as needed. The study will use RE-AIM to guide evaluation, with coprimary outcomes of Reach and HIV viral suppression, and mixed methods to assess intervention Adoption, Implementation, and Maintenance. The study draws on the CFIR framework to assess site-specific implementation determinants before and after the study period. The study will undertake micro-costing using a uniform cost data collection protocol to quantify the resources needed to carry out intervention activities.
Detailed description
Aim 1: Formative work guided by an implementation mapping process to engage key stakeholders, finalize implementation strategies to maximize successful implementation of the evidence-informed clinical intervention, and develop site specific adaptations of the interventions along with an implementation blueprint to guide intervention delivery. Proposed implementation strategies include 1) identify and prepare referral site champions, 2) audit and feedback for referral sites, 3) build a coalition between referral and study care sites, 4) assess for readiness and identify of implementation barriers at care sites, 5) adaptation of intervention components to site-specific context, 6) develop a formal implementation blueprint to guide site-specific intervention delivery, 7) develop educational materials and conduct ongoing training at each site to support implementation fidelity, and 8) create a learning collaborative to facilitate cross-site sharing of best practices and positive peer pressure.
Aim 2: Following initial formative work, a type 2 hybrid implementation-effectiveness study will be conducted using a prospective cohort of persons referred to drop-in/mobile HIV care at one of the four participating care sites (n=400). Patients are eligible for referral to the drop-in/mobile care model if they meet the following three criteria: 1) most recent HIV viral load >200 copies/mL or off ART by ≥1 month by self-report; 2) sub-optimal care engagement by self-report or chart history (defined as no current HIV primary care provider, no HIV primary care visit in the past 6 months, or ≥ 1 missed HIV primary care visit in the past 6 months); and 3) ≥1 major barrier to care engagement by self report, chart history, or clinical assessment (homelessness/unstable housing, any mental health diagnosis, any illicit substance use). The study will compare outcomes over 12 months to two propensity score-matched control groups: 1) contemporaneous patients identified using Alameda and San Francisco Departments of Public Health (DPH) HIV surveillance data (n=400) and 2) historical patients at participating clinic sites (n=400). The evaluation will be guided by the RE-AIM implementation framework, with co-primary outcomes of Reach (≥ 1 HIV primary care visit over 12 months following referral) and Effectiveness (≥1 HIV viral load <200 copies/mL over 12 months following referral).
In Aim 3: Impact Analysis to understand and model the individual, clinic, and population-level impacts of the staged care approach, the study will use several approaches: 1) Heterogeneity and Health Equity Analysis, 2) Pathway \& Scenario Analysis, 3) Cost and Cost-effectiveness Analysis, and 4) Population-level Health Impact Modeling. Analyses will use mixed-methods to assess for whom the staged care approach worked and did not work and why. The Cost and Cost-effectiveness Analysis will estimate total program costs, costs associated with each intervention strategy, cost per person referred, cost per person engaged in each intervention strategy and cost per person engaged in optimized pathways. Observed study outcomes and scenario analysis results will be used to estimate the additional number of patients with suppressed viral load within the entire program, for each intervention strategy and for the identified optimized pathways.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hybrid type 2 implementation-effectiveness Trial
| Arm | Type | Receives |
|---|---|---|
| Low-barrier drop-in and mobile care | Other | Other: Active Referral, Other: Drop-In Multidisciplinary HIV Care, Other: Mobile HIV Care, Other: Staged Care, Other: Identify and prepare champions at referral sites, Other: Audit and feedback at referral sites, Other: Build a coalition among referral and clinical sites, Other: Assess for readiness and identify barriers, Other: Promote adaptability, Other: Develop a formal implementation blueprint, Other: Develop educational materials; conduct ongoing training, Other: Create a learning collaborativeThis is a single-arm trial of a set of implementation strategies to encourage uptake of drop-in and mobile HIV care for people living with HIV who experience barriers to engage in usual scheduled appointments. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults or adolescents (≥15 years) living with HIV
- Most recent HIV viral load >200 copies/mL or off ART by ≥1 month by self-report
- Sub-optimal care engagement by self-report or chart history (defined as no current HIV primary care provider, no HIV primary care visit in the past 6 months, or ≥1 missed HIV primary care visit in the past 6 months)
- ≥1 major barrier to care engagement by self report or chart history (homelessness/ unstable housing, any mental health diagnosis, any illicit substance use).
Key exclusion criteria (1 listed)
- Inability to give informed consent due to cognitive impairment, psychosis, or intoxication.
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 |
|---|---|---|
| Active ReferralAs an implementation science study, all clinical intervention components will be delivered as part of routine clinical care at participating clinical sites. Clinicians and staff at referral sites throughout San Francisco and Alameda counties (emergency departments, psychiatric emergency services, community clinics, care navigation and case management programs, and community-based services) will refer eligible patients who are out of care and are interested in linking to drop-in and/or mobile care services at one of the study sites. Clinical referrals will include basic patient information and contact/locator information to facilitate linkage to care. Referrals will be site-specific based on the site where the patient is interested in accessing care. | Other | Low-barrier drop-in and mobile care |
| Drop-In Multidisciplinary HIV CareEach site will independently implement a drop-in multidisciplinary site-based HIV care model. Core intervention features include drop-in care (no appointments), panel management to review clinical progress for all referred patients, and case management. Each site may include adaptations to the care model determined during Aim 1 formative work. | Other | Low-barrier drop-in and mobile care |
| Mobile HIV CareEach site will independently implement a mobile care model using site-specific resources. At a minimum, the mobile care team will include a clinical nurse with telemedicine (video visit) consultation with a clinician (MD/NP/PA). Mobile teams will also administer medications (including long-acting ART when available) and collect laboratory specimens (e.g. HIV viral loads) | Other | Low-barrier drop-in and mobile care |
| Staged CareClinical decision rules to escalate/de-escalate care intensity will be finalized developed during Aim 1 formative work, though will be based on a combination of clinical assessment and patient preference. | Other | Low-barrier drop-in and mobile care |
| Identify and prepare champions at referral sitesIdentify implementation champions at each referral site. Champions will receive marketing materials to promote uptake of clinical referrals to a drop-in/mobile care site by referral site providers/staff. This strategy is aimed at improving referring provider confidence in the value of referral to the care model, reduce perceived referral complexity/improve provider capability to refer, and provide positive peer pressure to promote referrals. | Other | Low-barrier drop-in and mobile care |
| Audit and feedback at referral sitesInvestigators will provide monthly reports to implementation champions at each referral site on aggregate number of referrals and the success of referrals (proportion linking to care). This strategy is aimed at improving perceived value of the intervention and increasing provider motivation to refer. | Other | Low-barrier drop-in and mobile care |
| Build a coalition among referral and clinical sitesInvestigators will facilitate formation of a coalition of referral and clinic sites to improve cross-site collaboration and promote positive peer pressure to improve intra-site communication and increase referrals. | Other | Low-barrier drop-in and mobile care |
| Assess for readiness and identify barriersInvestigators will conduct patient in-depth interviews and clinical team focus group discussions to assess barriers to implementation of the clinical intervention. Findings from interviews and focus group discussions will inform site-specific implementation plans and adaptation of the intervention. | Other | Low-barrier drop-in and mobile care |
| Promote adaptabilityDuring a co-design workshop among drop-in/mobile care site teams and site-specific meetings, the study team will collectively finalize core clinical intervention components and outline site-specific adaptations (i.e. adaptable periphery of clinical intervention). | Other | Low-barrier drop-in and mobile care |
| Develop a formal implementation blueprintWith each drop-in/mobile care team, develop site-specific implementation plan that includes defining care team and leadership structure, clinic workflow, implementation timeline, and progress measures. This process, and the resulting blueprint, will incorporate site-specific barriers and facilitators to implementation. | Other | Low-barrier drop-in and mobile care |
| Develop educational materials; conduct ongoing trainingCompile a manual that includes detailed description of core intervention features, planned local adaptations, and implementation guidance. We will conduct site-specific meetings to provide training on this manual. We will also conduct regular (at least monthly) meetings between the study team and the clinic site to provide technical assistance and coaching. | Other | Low-barrier drop-in and mobile care |
| Create a learning collaborativeCreate a cross-site learning collaborative with periodic meetings and workshops throughout the study period to facilitate cross-site communication, sharing of best practices and encourage positive peer pressure to support implementation. | Other | Low-barrier drop-in and mobile care |
Primary outcome
Reach
Time frame: 12 months
Proportion of participants who access primary HIV care over the 12 months post-referral/ propensity matching.
Number of participants with HIV viral suppression
Time frame: 12 months
Number of participants with any HIV viral load <200 copies/mL during the 12 months following referral/propensity matching.
2 secondary outcomes
Evaluate sustained engagement in HIV care
Time frame: 12 months
Participants with durable viral suppression
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 24 Feb 2026.
- Derived from this study: PubMed 40163072Garner BR, Bouris A, Charlebois ED, Li DH, Dakin A, Moskowitz J, Benbow N, Christopoulos K, Hickey MD, Imbert E. The Strategies Timeline and Activities Reporting Tables: Improving HIV Care by Improving the Reporting of Implementation Strategies. J Acquir Immune Defic Syndr. 2025 Apr 15;98(5S):e205-e215. doi: 10.1097/QAI.0000000000003613.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified study data which includes subject demographics and study outcome measures consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards and include a descriptive data dictionary of the available dataset. The primary information sharing channel for the community will be community forums, and community advisory board meetings. Prior to dissemination, all data will be fully de-identified according to standard Safe Harbor guidelines. Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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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.
Jennifer Cohen, MPA contact
Katerina Christopoulos, MD, MPH principal investigator
University of California, San Francisco
Matthew Hickey, MD principal investigator
University of California, San Francisco
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Referral, Drop-In Multidisciplinary HIV Care and Mobile HIV Care in people with HIV, run by University of California, San Francisco at 5 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 4 inclusion and 1 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Katerina Christopoulos, MD, MPH (415-476-4082 ext. 440, Katerina.Christopoulos@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05887557, 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 24 Feb 2026.