The Collaborative Care PrTNER Study

NCT ID: NCT06585631

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-02
• Study Completion Date: 2028-06-30

Brief 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 Black and Latino men who have sex with men (YBLMSM) aged 15 to 24 through engagement in SU treatment.

Detailed Description

The Collaborative Care (CC) PrTNER is a multi-component intervention developed by members of the research team specifically for YBLMSM aged 15 to 24 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention

Participants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals.

Group Type: EXPERIMENTAL

CC PrTNER

Intervention Type: BEHAVIORAL

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.

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CC PrTNER

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Aim 1:

• 15-24 years old;
• Cisgender male;
• Self-identified Black/African American race or Latino/Hispanic ethnicity;
• Report prior oral/anal sex with another male;
• At-risk for HIV (condomless anal sex or positive sexually transmitted infection (STI) in last 6 months);
• 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;
• Able to read and write in English

Aim 2:

• 15-24 years old;
• Cisgender male;
• Self-identified Black/African American race or Latino/Hispanic ethnicity;
• Report prior oral/anal sex with another 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.

Exclusion Criteria

Aim 2:

• Participants will be excluded if they are:
• Assigned female sex at birth
• Identify as transgender
• Outside the age criteria (<15 or >24 years old)
• Cognitively unable to complete study requirements
• Living outside of the two geographic areas
• Do not screen positive for SU
• No prior substance use history
• No prior oral or anal sex;
• Unable to read or write in English,
• Plan to move in the next 12 months.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Baltimore City Health Department

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renata Sanders, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Johns Hopkins Center for Adolescent and Young Adult Health

Baltimore, Maryland, United States

Site Status: NOT_YET_RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Renata Sanders, MD

Role: CONTACT

sandersr2@chop.edu

215-590-5633

Facility Contacts

Christopher Hammond, MD

Role: primary

chammo20@jhmi.edu

410-550-0048

Bevin Gwiazdowski, MSW

Role: primary

gwiazdowsb@chop.edu

2158406813

Other Identifiers

R01DA059022

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-021859

Identifier Type: -

Identifier Source: org_study_id