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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA059022 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Baltimore City Health Department | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals. |
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| Standard of Care | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC PrTNER | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| HIV virologic suppression at 12 months | Viral load < 20 copies/mL from baseline to 12 months | 12 months |
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP persistence | Duration of time participants maintain benchmark TFV-DP concentrations from baseline to 12 months | 12 months |
| Sustained viral suppression | Duration of time participants are virally suppressed from baseline to 12 months |
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Inclusion Criteria:
Aim 1:
Aim 2:
Aim 3
• All randomized study participants will be included in Aim 3.
Exclusion Criteria:
Aim 2:
cis-gender young men
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renata Sanders, MD | Contact | 215-590-5633 | sandersr2@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Renata Sanders, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Center for Adolescent and Young Adult Health | Not yet recruiting | Baltimore | Maryland | 21205 | United States |
Data will be shared between sites and made available to other NIH funded researchers upon approval of written official request and shared via applicable Johns Hopkins University Data Transfer Agreements. No data will be released that would allow the identification of any respondent, unless written informed permission for this is obtained.
Data will also be shared with key stakeholders throughout the study, between sites, and made available to study participants after the analysis is completed. We will summarize and present findings in a summary report, webinar, and in a face-to-face meeting at each site once analyses are completed. The summary report will be emailed to participants, including, adolescents, providers, and community partners about the findings of the work. As part of the Center for AIDS Research (CFAR) Initiatives, we will share our findings and data, when appropriate, with the Baltimore and Philadelphia CFARs and Ryan White sites.
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Data will be shared between sites and with key stakeholders throughout the study. At the conclusion of the study data will be made available to participants.
Applicable Johns Hopkins University Data Transfer Agreements
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000163 | Acquired Immunodeficiency Syndrome |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
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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.
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| 12 months |
| 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 | 12 months |
| Mean number of negative urine drug screens (UDS) | Mean number of negative UDS at 12 months | 12 months |
| Substance-related problems | 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 | 12 months |
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19146 | United States |
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| D003141 |
| Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004327 | Drinking Behavior |
| D001519 | Behavior |