Substance Use DisordersNCT06439329
STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations
A study testing Standard PN and Patient Choice in people with Substance Use Disorders, run by Yale University at 1 site in United States.
Trial summary
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Standard PN and Patient Choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to provide written informed consent in English or Spanish;
- living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
- Those with current justice involvement (with in the past 6 months) (e.g., prison, jail, community supervision);
- willing to have HIV testing to determine negative or positive status;
- persons with HIV who report not currently taking ART and have a viral load >200 copies/mL in past 6 months OR persons who test negative for HIV who report not taking PrEP that meet CDC PrEP eligibility criteria in past 6 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
- Having a history of opioid and/or stimulant use within 12 months prior to being in a controlled setting and/or in the last 6 months within the community
Show all 12Show fewer
- Implementation portion/CAB members:
- able to provide written informed consent in English or Spanish;
- working with persons with a history of justice involvement and substance use in the areas targeted for this project
- PN Participants:
- able to provide written informed consent in English or Spanish;
- be employed at a project research site as a Patient Navigator
Who cannot join
- severe medical or psychiatric disability making participation unsafe;
- unable to provide consent.
- persons self-reporting pregnancy
- Implementation portion/CAB members:
- persons self-reporting pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
135 College St., Suite 280
New Haven, Connecticut, 06510
About this study
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
Read the detailed description
This study will be done in two phases. Phase 1 the R61 portion of the project will be a Pilot Study, and Phase 2 the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot (NCT07223398).
The focus of this registration is the pilot study. In Year 1 (R61; Aim 1) the intervention of the patient choice menu of options of PrEP/ART and SUD treatment services for justice involved people who use drugs (PWUD) to supplement established peer navigation (PN +PC) will be developed and pilot tested in Western Connecticut only (Fairfield, Litchfield, Southern New Haven Counties).
Implementation procedures for this study include needs assessment survey and focus groups consisting of CAB members and PNs to assess the types of services available in their community, as well as gaps in services and ideas of how services can be improved. These needs assessment surveys and focus groups will occur 3 times throughout the study.
- Conditions
- Substance Use Disorders
- Being tested
- Standard PN, Patient Choice
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PNBehavioural
Standard of care
Patient ChoiceBehavioural
Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.
| Study group | Role | What they receive |
|---|---|---|
| Standard Patient Navigation (PN) | Active comparator | PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides appointment scheduling to brick and mortar services only, and not to MHU or telehealth services. Receives: Behavioral: Standard PN |
| PN + Patient Choice (PC) (PN+PC) | Experimental | PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. Receives: Behavioral: Standard PN; Behavioral: Patient Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility/Acceptability Will be Assessed Using the CAB Community Needs Assessment
Attitudes toward acceptability and feasibility of the PN and PN+PC menu of options will be surveyed from CAB members using the needs assessment created during project ACTION as a foundation. Total score range is 5-20 for each category. Higher scores indicate increased acceptability, appropriateness, and feasibility.
Assessed only in CAB members.
Measured: 3 months
Feasibility/Acceptability Will be Assessed Using the Organizational Readiness for Implementing Change (ORIC) From the JCOIN Common Measure Survey
Organizational readiness for implementing change (ORIC) will be surveyed at start of preparation and sustainment phases with CAB members to evaluate confidence and commitment to using the PN+PC approach. Total scores range from 12 to 60, with higher scores indicating greater readiness. This survey was administered to CAB members only.
Measured: 3 months
Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC)
Participant attitudes toward the PN and PN+PC implementation approach (rapport, satisfaction, linkage to services, engagement) will be collected at 3 months using the Scales for Participant Alliance with Recovery Coach; SPARC. The SPARC is scored on a Likert scale (1 = strongly disagree to 5 = strongly agree), higher scores indicate a high perception of the recovery coach alliance. There are six domains (engagement, satisfaction, rapport, motivation and encouragement, role model, and community linkage), and each domain score is between 10 and 50.
Measured: 3 months
Number of Participants That Utilized Access of PrEP/ART Services
Utilization of Services and PN Engagement data will be used to assess the number of participants that utilized access of PrEP/ART services.
Measured: 3 months
Number of Participants With Receipt of Treatment
Defined as participants that have received a prescription for PrEP/ART
Measured: 3 months
Secondary outcomes (1)
Substance Use Treatment
Number of participants engaged in substance use disorder (SUD) treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start3 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Yale 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sandra Springer, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439329
- Sponsor's protocol ID
- 2000037052
- Other IDs
- 1R61DA060625-01
- Status last verified
- Jun 2026
- First submitted
- 28 May 2024
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations
- ClinicalTrials.gov ID
- NCT06439329
- Acronym / sponsor ID
- 2000037052
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Posted 17 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
Detailed description
This study will be done in two phases. Phase 1 the R61 portion of the project will be a Pilot Study, and Phase 2 the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot (NCT07223398).
The focus of this registration is the pilot study. In Year 1 (R61; Aim 1) the intervention of the patient choice menu of options of PrEP/ART and SUD treatment services for justice involved people who use drugs (PWUD) to supplement established peer navigation (PN +PC) will be developed and pilot tested in Western Connecticut only (Fairfield, Litchfield, Southern New Haven Counties).
Implementation procedures for this study include needs assessment survey and focus groups consisting of CAB members and PNs to assess the types of services available in their community, as well as gaps in services and ideas of how services can be improved. These needs assessment surveys and focus groups will occur 3 times throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Patient Navigation (PN) | Active comparator | Behavioral: Standard PNPNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides appointment scheduling to brick and mortar services only, and not to MHU or telehealth services. |
| PN + Patient Choice (PC) (PN+PC) | Experimental | Behavioral: Standard PN, Behavioral: Patient ChoicePNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- able to provide written informed consent in English or Spanish;
- living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
- Those with current justice involvement (with in the past 6 months) (e.g., prison, jail, community supervision);
- willing to have HIV testing to determine negative or positive status;
- persons with HIV who report not currently taking ART and have a viral load >200 copies/mL in past 6 months OR persons who test negative for HIV who report not taking PrEP that meet CDC PrEP eligibility criteria in past 6 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
Key exclusion criteria (5 listed)
- severe medical or psychiatric disability making participation unsafe;
- unable to provide consent.
- persons self-reporting pregnancy
- persons self-reporting pregnancy
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 |
|---|---|---|
| Standard PNStandard of care | Behavioural | PN + Patient Choice (PC) (PN+PC), Standard Patient Navigation (PN) |
| Patient ChoiceParticipants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services. | Behavioural | PN + Patient Choice (PC) (PN+PC) |
Primary outcome
Feasibility/Acceptability Will be Assessed Using the CAB Community Needs Assessment
Time frame: 3 months
Attitudes toward acceptability and feasibility of the PN and PN+PC menu of options will be surveyed from CAB members using the needs assessment created during project ACTION as a foundation. Total score range is 5-20 for each category. Higher scores indicate increased acceptability, appropriateness, and feasibility. Assessed only in CAB members.
Feasibility/Acceptability Will be Assessed Using the Organizational Readiness for Implementing Change (ORIC) From the JCOIN Common Measure Survey
Time frame: 3 months
Organizational readiness for implementing change (ORIC) will be surveyed at start of preparation and sustainment phases with CAB members to evaluate confidence and commitment to using the PN+PC approach. Total scores range from 12 to 60, with higher scores indicating greater readiness. This survey was administered to CAB members only.
Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC)
Time frame: 3 months
Participant attitudes toward the PN and PN+PC implementation approach (rapport, satisfaction, linkage to services, engagement) will be collected at 3 months using the Scales for Participant Alliance with Recovery Coach; SPARC. The SPARC is scored on a Likert scale (1 = strongly disagree to 5 = strongly agree), higher scores indicate a high perception of the recovery coach alliance. There are six domains (engagement, satisfaction, rapport, motivation and encouragement, role model, and community linkage), and each domain score is between 10 and 50.
Number of Participants That Utilized Access of PrEP/ART Services
Time frame: 3 months
Utilization of Services and PN Engagement data will be used to assess the number of participants that utilized access of PrEP/ART services.
Number of Participants With Receipt of Treatment
Time frame: 3 months
Defined as participants that have received a prescription for PrEP/ART
1 secondary outcome
Substance Use Treatment
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sandra Springer, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard PN and Patient Choice in people with Substance Use Disorders, run by Yale University at 1 site 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 12 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility/Acceptability Will be Assessed Using the CAB Community Needs Assessment (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.