SBCM-PrEP is a strengths-based case management (SBCM) program designed to expand low-threshold access to pre-exposure prophylaxis (PrEP) at needle and syringe programs (NSPs) for people in rural areas who use drugs. The program integrated PrEP education, screening, prescribing and monitoring at two NSPs while offering SBCM to support readiness and initiation. A pilot randomized clinical trial compared SBCM-PrEP with standard care (i.e., CDC-PrEP) which was based on materials from the US Centers for Disease Control and Prevention but did not provide SBCM. There were no statistically significant differences reported between the study arms, although results across both arms showed that co-locating PrEP services in NSPs is feasible. Across both study arms, 96.2% of participants attended at least one PrEP intervention session, 88.5% were linked to a PrEP provider, 28.5% were issued an initial PrEP prescription and 8.8% filled a prescription.
Program description
SBCM-PrEP is a multi-session intervention to address barriers to PrEP initiation among people in rural areas who use drugs. The program was integrated into two NSPs in rural Kentucky and provided PrEP education, screening, prescribing and monitoring, as well as action planning to increase readiness for and engagement in PrEP using SBCM.
Participants who were enrolled in one of the two NSP programs, had at least one occasion of injection drug use in the past month and had an indication for PrEP could enrol in the program. Following enrolment, participants were randomly assigned to either the SBCM-PrEP or CDC-PrEP arm of the study, and initial intervention sessions were scheduled with participants in both arms within one week of enrolment at NSPs.
Participants in the CDC-PrEP arm received one 20-minute session focused on PrEP and HIV education, the cost of PrEP, medication adherence and side effect. During this session they were referred to a PrEP provider for clinical evaluation, if interested.
Participants in the SBCM-PrEP arm received up to five strengths-based sessions. These sessions provided tailored PrEP education and engaged participants in action planning to increase their readiness for PrEP initiation. Session 1 was a one-hour individual session to build rapport and engagement between the participant and a staff member. This included information on SBCM, basic HIV education, tailored PrEP education and an interactive dialogue to help the staff member understand what may have prevented the participant from initiating PrEP. Using SBCM approaches, staff helped to reinforce the ability of participants to make decisions related to their health behaviours. The sessions summarized barriers, strengths and goals. All participants in the SBCM-PrEP arm were provided a warm referral to a PrEP provider for clinical PrEP evaluation if the participant was interested.
As noted above, participants in both study arms were referred to PrEP providers (i.e., advanced practice registered nurses) if they were interested. These providers were located at one of the NSPs, were trained in PrEP provision and were committed to harm reduction principles. These PrEP providers were available for four to eight hours per week during NSP operating hours. The clinical PrEP assessment included:
- HIV risk assessment
- PrEP counseling
- point-of-care HIV testing and urine testing for PrEP eligibility using home test kits (HIV antigen and antibody, hepatitis B surface antigen, creatinine and urine pregnancy testing)
Test kits were collected at the NSP and samples were mailed to a lab. Results were generally available within seven to 10 days. Participants were asked to return for a second clinical visit two weeks later to review test results with the PrEP provider, who could provide a prescription for PrEP if the participant was interested. Staff attempted to contact participants multiple times to encourage them to return for their second clinical visit. One NSP formed a close partnership with a local specialty pharmacy, which assisted with providing seamless and timely access to PrEP medications for participants.
SBCM-PrEP staff attempted to contact participants to remind them of intervention session appointments (up to five sessions in total) the day before each scheduled session, and participants were able to reschedule missed appointments.
Results
From November 1, 2022, to October 31, 2023, 80 participants were enrolled into this pilot study. Forty-one participants were enrolled in the SBCM-PrEP group (intervention arm) and 39 in the CDC-PrEP group (standard care arm). Overall, at baseline:
- participants reported injecting drugs an average of 3.2 times per day and 99 times in total in the last month
- 68.8% of participants reported injecting opioids in the past month; 31.3% reported using stimulants
- 42.5% of participants reported unstable housing within the past three months
- 52.5% of participants were female
- 82.5% of participants reported very low or low knowledge about PrEP
- 50.0% of participants reported very high or extremely high interest in learning more about PrEP
- 46.3% of participants had received substance use treatment in the past three months
In terms of attendance at education sessions, in the SBCM-PrEP arm of the study, 95.1% of participants (39/41) attended session 1, 14.6% (6/41) session 2, 2.4% (1/41) session 3 and zero attended sessions 4 and 5. In the CDC-PrEP arm, 97.4% of participants (38/39) attended the single session.
There were no statistical differences between the study arms. Across both arms, 96.2% (77/80) of participants entered the PrEP care cascade by attending at least one PrEP intervention session. Additionally:
- 87.5% (70/80) of participants were linked to the NSP-embedded PrEP provider and completed an initial PrEP clinical visit and point-of-care testing for PrEP eligibility
- 47.5% (38/80) attended the second PrEP clinical visit (to review initial lab results)
- 27.5% (22/80) were issued an initial prescription for PrEP
- 8.8% (7/80) filled the PrEP prescription (picked up their prescription) during the six-month study period
Reasons for not filling a PrEP prescription after completing eligibility testing included (but were not limited to): requiring retesting because of untimely follow-up (nine participants), actively declining prescription (three participants) and returning when the provider was not onsite (two participants).
In an analysis of participants enrolled in the study regardless of whether or not they received or completed the treatment to which they were assigned (i.e., intention to treat analysis), there was a 13.6% difference in prescription issuance between the SBCM-PrEP arm and the CDC-PrEP arm (34.1% vs. 20.5%, respectively) and a 12.1% difference in the PrEP initiation rate (i.e., prescription fill rate) between the arms (14.6% vs. 2.5%, respectively), but the differences were not statistically significant. No participants who were linked to the PrEP provider (70/80) tested positive for HIV during the study.
Implications for service providers
This study shows that the co-location of PrEP education and screening into an NSP was both feasible and acceptable. Use of this approach could address major barriers (e.g., lack of PrEP providers, stigmatizing experience with healthcare providers) and improve entry into the PrEP care cascade for people who use drugs in rural communities.
The study demonstrated very high initial engagement, with 96.2% of participants entering the PrEP care cascade and 87.5% completing an initial clinical visit — an encouraging sign of interest and willingness to engage in PrEP care. However, there was a notable drop-off at each subsequent step, with only 47.5% attending a second clinical visit, 27.5% receiving a PrEP prescription and just 8.8% ultimately filling their prescription. While these findings highlight challenges in retention and PrEP initiation, the strong early participation rate suggests that single-session interventions embedded in NSPs, where people are already receiving services, are enough to engage people in the PrEP cascade. However, strengthening support mechanisms and addressing barriers to follow-through could enhance PrEP uptake and adherence, maximizing the impact of these interventions. The study authors indicated that implementing same-day PrEP initiation could be considered in future approaches to continue engagement in the PrEP cascade.
Related resources
PrEP navigation for Black/African American men who have sex with men – CATIE evidence brief
What’s the 411 on PrEP 2-1-1? On-demand PrEP for preventing HIV – CATIE Prevention in Focus article
Dried blood spot testing at community-based locations – CATIE case study
Reference
Surrat HJ, Brown S, Burton Al et al. 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 service programs. Therapeutic Advances in Infectious Disease. 2025;12:1-17.