The Collaborative Care PrTNER Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age15-29
SponsorChildren's Hospital of Philadelphia
About 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 aged 15 to 29 through engagement in SU treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
15-24 years old;
Cisgender male;
History of condomless sex;
Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2,
Disqualifiers
Assigned female sex at birth
Identify as transgender
Outside the age criteria (<15 or >29 years old)
Cognitively unable to complete study requirements
Trial design
Design model
Parallel
Treatments tested in this trial
CC PrTNER
BehavioralParticipants randomized to CC PrTNER will be assigned a peer coach. They will conduct interviewer-administered behavioral surveys. The surveys provide an in-depth assessment of SU, HIV prevention and care, engagement, and adherence. Behavioral surveys are administered monthly. The coach will discuss with the participant the areas that are flagged by the psychiatrist; provide psychoeducation around areas identified, and work with the participant to identify their health goals and how changes in SU may help feed into self-defined goals. The coach will meet weekly with the consultant addiction psychiatrist who will make a provisional diagnosis and define a treatment plan with clear goals for treatment outcome. Recommendations will be communicated electronically to the HIV or PrEP provider to facilitate implementation. The coach utilizes MI skills to implement the individually tailored to facilitate the adoption and maintenance of health behaviors.
Treatment groups
275 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
PrEP uptake at 12 months
PrEP uptake from baseline to 12 month survey. Biomedical assessment of PrEP use at 12 months, Intraerythrocytic Tenofovir-Diphosphate (TVF-DP) from dried blood spot (DBS) \>700 fmol/punch (oral PrEP), 2+ on-time injections of Long-acting injectable cabotegravir (CAB-LA)
Time frame
12 months2
HIV virologic suppression at 12 months
Viral load \< 20 copies/mL from baseline to 12 months
Time frame
12 months3
Number of days of past-28-day non-tobacco drug/alcohol use
Number of days of past-28-day non-tobacco drug/alcohol use, assessed via Timeline Followback Method Assessment (TLFB) from baseline to 12 months
Time frame
12 monthsSecondary outcomes
1
PrEP persistence
Duration of time participants maintain benchmark TFV-DP concentrations from baseline to 12 months
Time frame
12 months2
Sustained viral suppression
Duration of time participants are virally suppressed from baseline to 12 months
Time frame
12 months3
Uptake of HIV Antiretroviral therapy (ART) treatment
Frequency of inadequate drug measurements and drug-resistant virus in those who are not virally suppressed from baseline to 12 months
Time frame
12 months4
Mean number of negative urine drug screens (UDS)
Mean number of negative UDS at 12 months
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
Johns Hopkins University
Collaborator
Baltimore City Health Department
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov