The Collaborative Care PrTNER Study

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: AIDS; Substance Use; HIV; Substance Use Disorders

Treatments: Behavioral: CC PrTNER

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06585631

23-021859

R01DA059022 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 275 estimated patients

Sex: Male

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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275 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: CC PrTNER

Standard of Care

No Intervention group

Description:

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.