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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA053140 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The overarching goal of this study is to adapt and feasibility test an evidence-based strengths-based case management (SBCM) intervention for pre-exposure prophylaxis (PrEP) initiation, and examine preliminary efficacy of the intervention comparators (SBCM-PrEP) and (Centers for Disease Control (CDC)-PrEP). Within this context, the Specific Aims are to: 1) Assess client, provider, organization, and structural-level facilitators and barriers to integration of a PrEP focused SBCM (SBCM-PrEP) intervention into routine syringe service program (SSP) practice; 2) Adapt an evidence-based SBCM protocol to provide PrEP intervention services for people who inject drugs (PWID) in SSP sites; and, 3) Examine feasibility, acceptability and preliminary efficacy of the adapted SBCM-PrEP. 80 participants will be randomized into: CDC-PrEP (an in-use PrEP intervention based on CDC guidelines) or SBCM-PrEP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDC-PrEP | Active Comparator | 1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting |
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| SBCM-PrEP | Experimental | Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBCM-PrEP | Behavioral | Multi-session SBCM intervention adapted for PrEP initiation focus |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Initiating PrEP | Documented PrEP initiation, measured by dispensed PrEP prescription. | 3 months post-baseline |
| Number of Participants Initiating PrEP | Documented PrEP initiation, measured by dispensed PrEP prescription. | 6 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Intervention Engagement Assessed by Session Checklist | 5 item Session Checklist completed by Interventionist post-session; range is 5-20, lower scores are higher engagement | 8 weeks post-baseline |
| Level of Intervention Satisfaction Assessed by the IAQ |
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Inclusion Criteria:
Exclusion Criteria:
• HIV-positive status
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| Name | Affiliation | Role |
|---|---|---|
| Hilary L Surratt, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35706473 | Result | Surratt HL, Yeager HJ, Adu A, Gonzalez EA, Nelson EO, Walker T. Pre-Exposure Prophylaxis Barriers, Facilitators and Unmet Need Among Rural People Who Inject Drugs: A Qualitative Examination of Syringe Service Program Client Perspectives. Front Psychiatry. 2022 May 30;13:905314. doi: 10.3389/fpsyt.2022.905314. eCollection 2022. | |
| 39137923 | Result | Surratt HL, Brown S, Burton AL, Cranford W, Green C, Mersch SM, Rains R, Westgate PM. Examining HIV pre-exposure prophylaxis (PrEP) acceptability among rural people who inject drugs: predictors of PrEP interest among syringe service program clients. AIDS Care. 2024 Dec;36(12):1858-1868. doi: 10.1080/09540121.2024.2390067. Epub 2024 Aug 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CDC-PrEP | 1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting CDC-PrEP: 1 session PrEP education following CDC guidelines |
| FG001 | SBCM-PrEP | Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Intervention Period |
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| Follow Up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | CDC-PrEP | 1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting CDC-PrEP: 1 session PrEP education following CDC guidelines |
| BG001 | SBCM-PrEP |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Initiating PrEP | Documented PrEP initiation, measured by dispensed PrEP prescription. | We analyzed both the intent to treat (ITT) and per protocol populations. Per protocol is reported here, which includes those with any exposure to the respective interventions. | Posted | Count of Participants | Participants | 3 months post-baseline |
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Participant level adverse events were collected over 6 months
Adverse events were generally collected during the course of follow-up assessments using standard study instrumentation. For participants lost to follow-up, study staff collected information on deaths through publicly available information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDC-PrEP | 1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting CDC-PrEP: 1 session PrEP education following CDC guidelines |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Gastrointestinal disorders | Systematic Assessment |
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Small sample size on the pilot was not sufficiently powered to determine efficacy, however, percent difference and effect size estimates were determined as intended.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hilary Surratt | University of Kentucky | 8595622458 | hilary.surratt@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 8, 2023 | Mar 4, 2025 | Prot_SAP_ICF_001.pdf |
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| CDC-PrEP |
| Behavioral |
1 session PrEP education following CDC guidelines |
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10 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 10-50, lower scores are higher acceptability |
| 8 weeks post-baseline |
| 39886694 | Result | Surratt HL, Brown S, Burton AL, Cranford W, Fanucchi LC, Green C, Mersch SM, Rains R, Westgate PM. Outcomes of a pilot randomized clinical trial testing brief interventions to increase HIV pre-exposure prophylaxis uptake among rural people who inject drugs attending syringe services programs. Ther Adv Infect Dis. 2025 Jan 29;12:20499361251314766. doi: 10.1177/20499361251314766. eCollection 2025 Jan-Dec. |
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Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus
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| Primary | Number of Participants Initiating PrEP | Documented PrEP initiation, measured by dispensed PrEP prescription. | We analyzed intent to treat (ITT) and per protocol populations. Per protocol is reported here, which includes all participants with any exposure to their respective intervention. | Posted | Count of Participants | Participants | 6 months post-baseline |
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| Secondary | Level of Intervention Engagement Assessed by Session Checklist | 5 item Session Checklist completed by Interventionist post-session; range is 5-20, lower scores are higher engagement | Intervention engagement measure using the session checklist was collected only on the experimental arm; session checklist ratings are part of the SBCM-PrEP post session checklist forms only per study protocol, administration was planned post each of the 5 offered sessions. One SBCM-PrEP participant is missing data on this measure. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks post-baseline |
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| Secondary | Level of Intervention Satisfaction Assessed by the IAQ | 10 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 10-50, lower scores are higher acceptability | IAQ acceptability measures were collected from the experimental SBCM-PrEP arm only as part of the post-intervention session forms per protocol. The IAQ is a descriptive measure of acceptability of the newly adapted intervention, not planned for cross-arm comparative analysis. The IAQ is a participant-completed paper survey given to participants post-session to complete independently, which accounts for the high level of missingness; many participants did not return the survey. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks post-baseline |
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| 0 |
| 39 |
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| 39 |
| 0 |
| 39 |
| EG001 | SBCM-PrEP | Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting SBCM-PrEP: Multi-session SBCM intervention adapted for PrEP initiation focus | 1 | 41 | 1 | 41 | 0 | 41 |
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