PrTNER Program for HIV Prevention

(PrTNER Trial)

Recruiting at 1 trial location

Overseen By Renata Sanders, MD

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Transgender, Outside age criteria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

275 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Renata Sanders, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for young Black and Latino men aged 15-24 who have sex with men, are at risk for HIV or living with HIV/AIDS, and dealing with substance use disorders. Participants should be interested in starting PrEP to prevent HIV or aiming to reduce their viral load if they already have HIV.

Inclusion Criteria

I am a 15-24 year old Black or Latino male, had male-male sex, at HIV risk, not on PrEP, use substances, live near Philadelphia or Baltimore, and speak 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 a period of time in the last 6 months not taking oral/injectable ART exactly as prescribed 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: 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 consistent oral/injectable PrEP use the last 6 months or consistent oral/injectable ART use the last 6 months unable to read or write in English plan to move in the next 12 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys and sample collection

1 visit

1 visit (in-person)

Intervention

Participants in the CC PrTNER arm receive psychoeducation, identify health goals, and are assigned a peer coach. Standard of Care participants receive provider alerts and potential referrals.

12 months

Visits at baseline, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for PrEP uptake, HIV virologic suppression, and substance use outcomes

12 months

Treatment Details

Interventions

• CC PrTNER

Trial Overview The study is testing a Collaborative Care approach called PrTNER aimed at helping participants start on preexposure prophylaxis (PrEP) if they're at risk of getting HIV, or manage their health better to decrease the viral load if they're already living with HIV.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Standard of Care Active Control 1 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 Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Baltimore City Health Department

Collaborator

Trials

9

Recruited

19,200+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+