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Intervention for HIV/AIDS (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
* Aim 1: (1) 15-24 years old (2) cisgender male; (3) self-identified Black/African American race or Latino/Hispanic ethnicity; (4) report prior oral/anal sex with another male; (5) at-risk for HIV (condomless anal sex or positive sexually transmitted infection (STI) in last 6 months); (6) a period of time in the last 6 months not taking oral PrEP/injectable PrEP exactly as prescribed; and (7) moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2, (8) living in Philadelphia, PA or Baltimore, MD, and surrounding areas; and (9) able to read and write in English
* Aim 2: (1) 15-24 years old; (2) cisgender male; (3) self-identified Black/African American race or Latino/Hispanic ethnicity; (4) report prior oral/anal sex with another male; (5) living with a diagnosis of HIV; (6) a period of time in the last 6 months not taking oral/injectable ART exactly as prescribed; and (7) CRAFFT score ≥2, (8) living in Philadelphia, PA or Baltimore, MD, and surrounding areas; and (9) able to read and write in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.

Eligible Conditions
  • HIV/AIDS
  • Substance Use Disorder
  • Substance Abuse
  • Acquired Immunodeficiency Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

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.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
721 Previous Clinical Trials
8,594,612 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,136,380 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,305 Previous Clinical Trials
14,856,431 Total Patients Enrolled
~183 spots leftby Jun 2028
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