AIDS, HIV, Substance Use, Substance Use Disorders
Conditions
Keywords
HIV, AIDS, Substance use, Substances use disorder, drug use, alcohol use, preexposure prophylaxis, PrEP, peer coaches, community health worker, young men, adolescents, young male, young males, adolescent males
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 aged 15 to 29 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 young men aged 15 to 29 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).
Interventions
BEHAVIORALCC PrTNER
Participants 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.
Sponsors
Children's Hospital of Philadelphia
Johns Hopkins University
Baltimore City Health Department
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Young men 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, 20-24) & older (25-29) 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. 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.
Eligibility
Sex/Gender
MALE
Age
15 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
Aim 1: * 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, * Living in Philadelphia, PA or Baltimore, MD, and surrounding areas; * Able to read and write in English Aim 2: * 15-29 years old; * Cisgender 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 \>29 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 condomless sex; * Unable to read or write in English, * Plan to move in the next 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP uptake at 12 months | 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) |
| HIV virologic suppression at 12 months | 12 months | Viral load \< 20 copies/mL from baseline to 12 months |
| Number of days of past-28-day non-tobacco drug/alcohol use | 12 months | Number of days of past-28-day non-tobacco drug/alcohol use, assessed via Timeline Followback Method Assessment (TLFB) from baseline to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP persistence | 12 months | Duration of time participants maintain benchmark TFV-DP concentrations from baseline to 12 months |
| Sustained viral suppression | 12 months | Duration of time participants are virally suppressed from baseline to 12 months |
| Uptake of HIV Antiretroviral therapy (ART) treatment | 12 months | Frequency of inadequate drug measurements and drug-resistant virus in those who are not virally suppressed from baseline to 12 months |
| Mean number of negative urine drug screens (UDS) | 12 months | Mean number of negative UDS at 12 months |
| Substance-related problems | 12 months | Substance-related problems as defined by Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test - Revised (CUDIT-R), and Severity of Dependence Scale (SDS scores) from baseline to 12 months |
Countries
United States
Contacts
CONTACTRenata Sanders, MD
PRINCIPAL_INVESTIGATORRenata Sanders, MD
Children's Hospital of Philadelphia
Outcome results
None listed