Clinical trial NCT06585631: The Collaborative Care PrTNER Study
Official title: The Collaborative Care PrTNER (Prevention, Treatment, Navigation, Engagement, Resource) Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Substance Use Disorders
Substance Use
AIDS
Keywords: Gay, Bisexual
Young men who have sex with men
Young Black men who have sex with men
Young Latino men who have sex with men
HIV
AIDS
Substance use
Substances use disorder
men who have sex with men
young gay men
gay men
drug use
alcohol use
preexposure prophylaxis
PrEP
peer coaches
community health worker
LGBT
bisexual
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Baltimore City Health Department
First posted: 2024-09-05
Enrollment: 275
Sex: MALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: YBLMSM 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) and older (20-24) 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 to 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.
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: PrEP uptake at 12 months
timeFrame: 12 months
measure: HIV virologic suppression at 12 months
timeFrame: 12 months
measure: Number of days of past-28-day non-tobacco drug/alcohol use
timeFrame: 12 months
Secondary outcomes:
measure: PrEP persistence
timeFrame: 12 months
measure: Sustained viral suppression
timeFrame: 12 months
measure: Uptake of HIV Antiretroviral therapy (ART) treatment
timeFrame: 12 months
measure: Mean number of negative urine drug screens (UDS)
timeFrame: 12 months
measure: Substance-related problems
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Center for Adolescent and Young Adult Health
state: Maryland
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Renata Sanders, MD
role: PRINCIPAL_INVESTIGATOR
References: