HIV Prevention
Conditions
Brief summary
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.
Interventions
BEHAVIORALSBCM-PrEP
Multi-session SBCM intervention adapted for PrEP initiation focus
BEHAVIORALCDC-PrEP
1 session PrEP education following CDC guidelines
Sponsors
National Institute on Drug Abuse (NIDA)
Hilary L Surratt, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older; * HIV-negative status; * Past month drug injection; * Client of SSP in targeted sites
Exclusion criteria
• HIV-positive status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Initiating PrEP | 3 months post-baseline | Documented PrEP initiation, measured by dispensed PrEP prescription. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Intervention Engagement Assessed by Session Checklist | 8 weeks post-baseline | 5 item Session Checklist completed by Interventionist post-session; range is 5-20, lower scores are higher engagement |
| Level of Intervention Satisfaction Assessed by the IAQ | 8 weeks post-baseline | 10 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 10-50, lower scores are higher acceptability |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| 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 | 41 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow Up Period | Death | 0 | 1 |
| Follow Up Period | Incarcerated | 4 | 2 |
| Follow Up Period | Lost to Follow-up | 16 | 21 |
| Intervention Period | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | SBCM-PrEP | Total | CDC-PrEP |
|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 9.8 | 39.7 years STANDARD_DEVIATION 9.2 | 40.5 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 79 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 75 Participants | 35 Participants |
| Sex: Female, Male Female | 23 Participants | 42 Participants | 19 Participants |
| Sex: Female, Male Male | 18 Participants | 38 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 1 / 41 |
| other Total, other adverse events | 0 / 39 | 0 / 41 |
| serious Total, serious adverse events | 0 / 39 | 1 / 41 |
Outcome results
Primary
Number of Participants Initiating PrEP
Documented PrEP initiation, measured by dispensed PrEP prescription.
Time frame: 3 months post-baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDC-PrEP | Number of Participants Initiating PrEP | 1 Participants |
| SBCM-PrEP | Number of Participants Initiating PrEP | 6 Participants |
p-value: <0.0595% CI: [0.8, 62.2]Regression, Logistic
Primary
Number of Participants Initiating PrEP
Documented PrEP initiation, measured by dispensed PrEP prescription.
Time frame: 6 months post-baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDC-PrEP | Number of Participants Initiating PrEP | 1 Participants |
| SBCM-PrEP | Number of Participants Initiating PrEP | 6 Participants |
p-value: <0.0595% CI: [0.8, 62.2]Regression, Logistic
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
Time frame: 8 weeks post-baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SBCM-PrEP | Level of Intervention Engagement Assessed by Session Checklist | 8.68 units on a scale | Standard Deviation 2.96 |
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
Time frame: 8 weeks post-baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SBCM-PrEP | Level of Intervention Satisfaction Assessed by the IAQ | 13.2 units on a scale | Standard Deviation 3.07 |