HIVPrTNERNCT06585631

The Collaborative Care PrTNER Study

A study testing CC PrTNER in people with HIV and Substance Use Disorders, run by Children's Hospital of Philadelphia at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young aged 15 to 29… Read more about this study

Who is it for?: Ages 15 to 29 years, men onlyHealthy volunteers can take part
Conditions the study is for: HIV, Substance Use Disorders, Substance Use
What is being tested?: CC PrTNER
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 275 participants
Where: 2 sitesUnited States
Study dates: 2 Jan 2025to 30 Jun 2028
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 to 29 years
Men only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Aim 1:
15-24 years old;
Cisgender male;
History of condomless sex;
Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2,
Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;

Show all 16Show fewer

Able to read and write in English
Aim 2:
15-29 years old;
Cisgender male;
Living with a diagnosis of HIV;
CRAFFT score ≥2,
Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;
Able to read and write in English
Aim 3
All randomized study participants will be included in Aim 3.

Who cannot join

Aim 2:
Participants will be excluded if they are:
Assigned female sex at birth
Identify as transgender
Outside the age criteria (<15 or >29 years old)
Cognitively unable to complete study requirements

Show all 12Show fewer

Living outside of the two geographic areas
Do not screen positive for SU
No prior substance use history
No prior condomless sex;
Unable to read or write in English,
Plan to move in the next 12 months.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Renata Sanders, MD contact

215-590-5633

sandersr2@chop.edu

United States2 sites, 2 recruiting

Johns Hopkins Center for Adolescent and Young Adult Health
Baltimore, Maryland, 21205
Christopher Hammond, MD, 410-550-0048, chammo20@jhmi.edu
Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Bevin Gwiazdowski, MSW, 215-840-6813, gwiazdowsb@chop.edu
Marne Castillo, PhD, MEd
Recruiting

Other trials in United States

About this study

Official title: The Collaborative Care PrTNER (Prevention, Treatment, Navigation, Engagement, Resource) Project

Read the detailed description

The Collaborative Care (CC) PrTNER is a multi-component intervention developed by members of the research team specifically for young men aged 15 to 29 who are at-risk for or living with HIV. This model moves beyond the individual to consider the broader context in which, substance use (SU), and HIV risk are (re)produced.

Enhanced models that integrate SU treatment into HIV and PrEP primary care services (using a collaborative care approach that incorporates feedback from a psychiatrist and support from a peer coach) are needed to address the nuance of substance use in this population. We, therefore, are proposing to conduct a randomized trial to evaluate an integrated collaborative care model (CC PrTNER).

Conditions: HIV, Substance Use Disorders, Substance Use, AIDS
Being tested: CC PrTNER
Keywords: HIV, AIDS, Substance use, Substances use disorder, drug use, alcohol use, preexposure prophylaxis, PrEP, peer coaches, community health worker, young men, adolescents, young male, young males, adolescent males
Medical subject headings: Substance-Related Disorders, Acquired Immunodeficiency Syndrome, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CC PrTNERBehavioural
Participants randomized to CC PrTNER will be assigned a peer coach. They will conduct interviewer-administered behavioral surveys. The surveys provide an in-depth assessment of SU, HIV prevention and care, engagement, and adherence. Behavioral surveys are administered monthly. The coach will discuss with the participant the areas that are flagged by the psychiatrist; provide psychoeducation around areas identified, and work with the participant to identify their health goals and how changes in SU may help feed into self-defined goals. The coach will meet weekly with the consultant addiction psychiatrist who will make a provisional diagnosis and define a treatment plan with clear goals for treatment outcome. Recommendations will be communicated electronically to the HIV or PrEP provider to facilitate implementation. The coach utilizes MI skills to implement the individually tailored to facilitate the adoption and maintenance of health behaviors.

Study groups in NCT06585631
Study group	Role	What they receive
Intervention	Experimental	Participants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals. Receives: Behavioral: CC PrTNER
Standard of Care	No intervention	The participant's provider will receive an electronic alert in real time of the participant's positive screen for SU and a list of area substance treatment resources. The provider at their discretion will provide counseling or initiate a referral to in-clinic or community-based resources for SU assessment and treatment. Each of our clinical sites has case management resources for counseling and support for linkage to co-located SU treatment or community-based resources for inpatient or outpatient SU treatment as indicated at the discretion of the HIV/PrEP provider. SOC arm participants will not be assigned a coach. Study visit surveys and sample collection at baseline, 3, 6, 9, and 12 months are identical for intervention and SOC arm participants. Research personnel will make no attempts to provide brief intervention, motivational interviewing (MI), or case management.

What is being measured

The primary outcome is the main question the study is designed to answer.

PrEP uptake at 12 months
PrEP uptake from baseline to 12 month survey. Biomedical assessment of PrEP use at 12 months, Intraerythrocytic Tenofovir-Diphosphate (TVF-DP) from dried blood spot (DBS) >700 fmol/punch (oral PrEP), 2+ on-time injections of Long-acting injectable cabotegravir (CAB-LA)
Measured: 12 months
HIV virologic suppression at 12 months
Viral load < 20 copies/mL from baseline to 12 months
Measured: 12 months
Number of days of past-28-day non-tobacco drug/alcohol use
Number of days of past-28-day non-tobacco drug/alcohol use, assessed via Timeline Followback Method Assessment (TLFB) from baseline to 12 months
Measured: 12 months

Secondary outcomes (5)

PrEP persistence
Duration of time participants maintain benchmark TFV-DP concentrations from baseline to 12 months
Measured: 12 months
Sustained viral suppression
Duration of time participants are virally suppressed from baseline to 12 months
Measured: 12 months
Uptake of HIV Antiretroviral therapy (ART) treatment
Frequency of inadequate drug measurements and drug-resistant virus in those who are not virally suppressed from baseline to 12 months
Measured: 12 months
Mean number of negative urine drug screens (UDS)
Mean number of negative UDS at 12 months
Measured: 12 months
Substance-related problems
Substance-related problems as defined by Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test - Revised (CUDIT-R), and Severity of Dependence Scale (SDS scores) from baseline to 12 months
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 202530 Jun 2028

First posted5 Sep 2024
Study start2 Jan 2025
Primary completion30 Jun 2028 (estimated)
Study completion30 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe 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: Randomised
Intervention model: Parallel groups
Model description: Young men will be randomized (1:1) to intervention vs. SOC for each aim, using a computer-stratified randomization to yield balanced randomization between younger (15-19, 20-24) \& older (25-29) age groups and based on substance use risk as determined by their screener questionnaire. A separate stratum will be defined for each combination of covariates (age group and substance use risk) and participants will be randomized. Participants will sign a release of medical information for HIV/SU/Mental Health Disorders outcomes. Visits occur at baseline (time 0), 3, 6, 9, and 12 months. Participants will complete an interviewer-administered, electronic baseline and quarterly surveys followed by the collection of samples for biologic measures. Survey assess individual, interpersonal, multi-level barriers to HIV prevention care and treatment in the community, and structural levels. The survey will identify varying severity of hazardous/harmful substance use and co-existing mental health needs.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 275 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06585631
Sponsor's protocol ID: 23-021859
Other IDs: R01DA059022
Acronym: PrTNER
Status last verified: May 2026
First submitted: 3 Sep 2024
Last updated: 18 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be shared between sites and made available to other NIH funded researchers upon approval of written official request and shared via applicable Johns Hopkins University Data Transfer Agreements. No data will be released that would allow the identification of any respondent, unless written informed permission for this is obtained. Data will also be shared with key stakeholders throughout the study, between sites, and made available to study participants after the analysis is completed. We will summarize and present findings in a summary report, webinar, and in a face-to-face meeting at each site once analyses are completed. The summary report will be emailed to participants, including, adolescents, providers, and community partners about the findings of the work. As part of the Center for AIDS Research (CFAR) Initiatives, we will share our findings and data, when appropriate, with the Baltimore and Philadelphia CFARs and Ryan White sites.

Interested in taking part?

Renata Sanders, MD

215-590-5633

sandersr2@chop.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Collaborative Care PrTNER (Prevention, Treatment, Navigation, Engagement, Resource) Project
ClinicalTrials.gov ID: NCT06585631
Acronym / sponsor ID: PrTNER / 23-021859
Conditions: HIV, Substance Use Disorders, Substance Use, AIDS
Keywords: HIV, AIDS, Substance use, Substances use disorder, drug use, alcohol use, preexposure prophylaxis, PrEP
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 275 participants (estimated)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: Johns Hopkins University, Baltimore City Health Department, National Institute on Drug Abuse (NIDA)
Study start: 2 Jan 2025 (actual)
Primary completion: 30 Jun 2028 (estimated)
Study completion: 30 Jun 2028 (estimated)
First posted: 5 Sep 2024 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Young men will be randomized (1:1) to intervention vs. SOC for each aim, using a computer-stratified randomization to yield balanced randomization between younger (15-19, 20-24) \& older (25-29) age groups and based on substance use risk as determined by their screener questionnaire. A separate stratum will be defined for each combination of covariates (age group and substance use risk) and participants will be randomized. Participants will sign a release of medical information for HIV/SU/Mental Health Disorders outcomes. Visits occur at baseline (time 0), 3, 6, 9, and 12 months. Participants will complete an interviewer-administered, electronic baseline and quarterly surveys followed by the collection of samples for biologic measures. Survey assess individual, interpersonal, multi-level barriers to HIV prevention care and treatment in the community, and structural levels. The survey will identify varying severity of hazardous/harmful substance use and co-existing mental health needs.

Arm	Type	Receives
Intervention	Experimental	Behavioral: CC PrTNERParticipants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals.
Standard of Care	No intervention	–The participant's provider will receive an electronic alert in real time of the participant's positive screen for SU and a list of area substance treatment resources. The provider at their discretion will provide counseling or initiate a referral to in-clinic or community-based resources for SU assessment and treatment. Each of our clinical sites has case management resources for counseling and support for linkage to co-located SU treatment or community-based resources for inpatient or outpatient SU treatment as indicated at the discretion of the HIV/PrEP provider. SOC arm participants will not be assigned a coach. Study visit surveys and sample collection at baseline, 3, 6, 9, and 12 months are identical for intervention and SOC arm participants. Research personnel will make no attempts to provide brief intervention, motivational interviewing (MI), or case management.

Who may qualify

Ages: 15 to 29 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (16 listed)

15-24 years old;
Cisgender male;
History of condomless sex;
Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2,
Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;

Key exclusion criteria (12 listed)

Participants will be excluded if they are:
Assigned female sex at birth
Identify as transgender
Outside the age criteria (<15 or >29 years old)
Cognitively unable to complete study requirements

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
CC PrTNERParticipants randomized to CC PrTNER will be assigned a peer coach. They will conduct interviewer-administered behavioral surveys. The surveys provide an in-depth assessment of SU, HIV prevention and care, engagement, and adherence. Behavioral surveys are administered monthly. The coach will discuss with the participant the areas that are flagged by the psychiatrist; provide psychoeducation around areas identified, and work with the participant to identify their health goals and how changes in SU may help feed into self-defined goals. The coach will meet weekly with the consultant addiction psychiatrist who will make a provisional diagnosis and define a treatment plan with clear goals for treatment outcome. Recommendations will be communicated electronically to the HIV or PrEP provider to facilitate implementation. The coach utilizes MI skills to implement the individually tailored to facilitate the adoption and maintenance of health behaviors.	Behavioural	Intervention

Primary outcome

PrEP uptake at 12 months
Time frame: 12 months
PrEP uptake from baseline to 12 month survey. Biomedical assessment of PrEP use at 12 months, Intraerythrocytic Tenofovir-Diphosphate (TVF-DP) from dried blood spot (DBS) >700 fmol/punch (oral PrEP), 2+ on-time injections of Long-acting injectable cabotegravir (CAB-LA)
HIV virologic suppression at 12 months
Time frame: 12 months
Viral load < 20 copies/mL from baseline to 12 months
Number of days of past-28-day non-tobacco drug/alcohol use
Time frame: 12 months
Number of days of past-28-day non-tobacco drug/alcohol use, assessed via Timeline Followback Method Assessment (TLFB) from baseline to 12 months

5 secondary outcomes

PrEP persistence
Time frame: 12 months
Sustained viral suppression
Time frame: 12 months
Uptake of HIV Antiretroviral therapy (ART) treatment
Time frame: 12 months
Mean number of negative urine drug screens (UDS)
Time frame: 12 months
Substance-related problems
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 18 May 2026.
Individual participant dataSharing planned: Yes. Data will be shared between sites and made available to other NIH funded researchers upon approval of written official request and shared via applicable Johns Hopkins University Data Transfer Agreements. No data will be released that would allow the identification of any respondent, unless written informed permission for this is obtained. Data will also be shared with key stakeholders throughout the study, between sites, and made available to study participants after the analysis is completed. We will summarize and present findings in a summary report, webinar, and in a face-to-face meeting at each site once analyses are completed. The summary report will be emailed to participants, including, adolescents, providers, and community partners about the findings of the work. As part of the Center for AIDS Research (CFAR) Initiatives, we will share our findings and data, when appropriate, with the Baltimore and Philadelphia CFARs and Ryan White sites.

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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.

Renata Sanders, MD contact

215-590-5633

sandersr2@chop.edu

Renata Sanders, MD principal investigator

Children's Hospital of Philadelphia

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CC PrTNER in people with HIV and Substance Use Disorders, run by Children's Hospital of Philadelphia at 2 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 16 inclusion and 12 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Renata Sanders, MD (215-590-5633, sandersr2@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP uptake at 12 months (time frame: 12 months). The study lists 3 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 NCT06585631.

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 18 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.