HIV PreventionNCT05037513

Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

A study testing SBCM-PrEP and CDC-PrEP in people with HIV Prevention, run by Hilary L Surratt, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: HIV Prevention
What is being tested?: SBCM-PrEP and CDC-PrEP
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 16 Sep 2021to 9 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years or older;
HIV-negative status;
Past month drug injection;
Client of SSP in targeted sites

Who cannot join

HIV-positive status

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kentucky
Lexington, Kentucky, 40536

Other trials in United States

About this study

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.

Conditions: HIV Prevention
Being tested: SBCM-PrEP, CDC-PrEP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SBCM-PrEPBehavioural
Multi-session SBCM intervention adapted for PrEP initiation focus
CDC-PrEPBehavioural
1 session PrEP education following CDC guidelines

Study groups in NCT05037513
Study group	Role	What they receive
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 Receives: Behavioral: CDC-PrEP
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 Receives: Behavioral: SBCM-PrEP

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Initiating PrEP
Documented PrEP initiation, measured by dispensed PrEP prescription.
Measured: 3 months post-baseline
Number of Participants Initiating PrEP
Documented PrEP initiation, measured by dispensed PrEP prescription.
Measured: 6 months post-baseline

Secondary outcomes (2)

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
Measured: 8 weeks post-baseline
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
Measured: 8 weeks post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 20219 Apr 2024

First posted8 Sep 2021
Study start16 Sep 2021
Primary completion9 Apr 2024
Study completion9 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HIV PreventionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05037513
Sponsor's protocol ID: 67933
Other IDs: R34DA053140
Status last verified: Mar 2025
First submitted: 5 Aug 2021
Last updated: 20 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35706473
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.
PubMed 39137923
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.
PubMed 39886694

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
ClinicalTrials.gov ID: NCT05037513
Acronym / sponsor ID: 67933
Conditions: HIV Prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Hilary L Surratt, PhDUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 16 Sep 2021 (actual)
Primary completion: 9 Apr 2024 (actual)
Study completion: 9 Apr 2024 (actual)
First posted: 8 Sep 2021 (actual)
Results: Posted 20 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CDC-PrEP	Active comparator	Behavioral: CDC-PrEP1 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
SBCM-PrEP	Experimental	Behavioral: SBCM-PrEPMulti-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

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 years or older;
HIV-negative status;
Past month drug injection;
Client of SSP in targeted sites

Key exclusion criteria (1 listed)

HIV-positive status

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SBCM-PrEPMulti-session SBCM intervention adapted for PrEP initiation focus	Behavioural	SBCM-PrEP
CDC-PrEP1 session PrEP education following CDC guidelines	Behavioural	CDC-PrEP

Primary outcome

Number of Participants Initiating PrEP
Time frame: 3 months post-baseline
Documented PrEP initiation, measured by dispensed PrEP prescription.
Number of Participants Initiating PrEP
Time frame: 6 months post-baseline
Documented PrEP initiation, measured by dispensed PrEP prescription.

2 secondary outcomes

Level of Intervention Engagement Assessed by Session Checklist
Time frame: 8 weeks post-baseline
Level of Intervention Satisfaction Assessed by the IAQ
Time frame: 8 weeks post-baseline

Results and safety

Results posted to the registry on 20 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CDC-PrEP	39	38
SBCM-PrEP	41	39

Primary outcome: Number of Participants Initiating PrEP

Time frame: 3 months post-baseline. Count of participants. Unit: Participants

Measure	CDC-PrEP n = 38	SBCM-PrEP n = 39
Value	1	6

CDC-PrEP vs SBCM-PrEP: Odds Ratio (OR): 7.06 (95% CI 0.8 to 62.2), p <0.05, Regression, Logistic

Population analysed: 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.

Primary outcome: Number of Participants Initiating PrEP

Time frame: 6 months post-baseline. Count of participants. Unit: Participants

Measure	CDC-PrEP n = 38	SBCM-PrEP n = 39
Value	1	6

CDC-PrEP vs SBCM-PrEP: Odds Ratio (OR): 7.06 (95% CI 0.8 to 62.2), p <0.05, Regression, Logistic

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participant level adverse events were collected over 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CDC-PrEP	0 of 39 (0%)	0 of 39 (0%)	0 of 39
SBCM-PrEP	1 of 41 (2.4%)	0 of 41 (0%)	1 of 41

Limitations and caveats (from the sponsor): Small sample size on the pilot was not sufficiently powered to determine efficacy, however, percent difference and effect size estimates were determined as intended.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35706473Surratt 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.
Results publication: PubMed 39137923Surratt 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.
Results publication: PubMed 39886694Surratt 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.
Individual participant dataSharing planned: No

Related trials for HIV Prevention

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hilary L Surratt, PhD principal investigator

University of Kentucky

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SBCM-PrEP and CDC-PrEP in people with HIV Prevention, run by Hilary L Surratt, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Initiating PrEP (time frame: 3 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05037513, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.