PrTNER Program for HIV Prevention (PrTNER Trial)

N/A

Waitlist Available

Led By Renata Sanders, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a new program called PrTNER can help young Black and Latino men who have sex with men to start taking PrEP to prevent HIV and reduce the levels of HIV in

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on care coordination rather than medication, side effects aren't the main concern. However, any interventions like PrEP may carry risks such as nausea, headache, stomach pain which will be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HIV virologic suppression at 12 months

Number of days of past-28-day non-tobacco drug/alcohol use

PrEP uptake at 12 months

Secondary study objectives

Mean number of negative urine drug screens (UDS)

PrEP persistence

Substance-related problems

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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 CareActive Control1 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.

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