A Systems Analysis and Improvement Approach for Optimizing HIV Service Delivery in Syringe Services Programs

NCT06025435 | Active Not Recruiting

• 2 other identifiers: 38233R01DA056883
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the effectiveness of an evidence-based, organizational-level implementation strategy, the Systems Analysis and Improvement Approach, in improving HIV service delivery (SAIA-SSP-HIV) in U.S. syringe services programs (SSPs). The main questions it aims to answer are:

• Does SAIA-SSP-HIV improve delivery of HIV services (including the proportion of SSP participants receiving HIV testing and referrals to appropriate clinical services for HIV prevention and treatment) compared to implementation as usual (IAU)?
• Does SAIA-SSP-HIV result in sustained improvement of HIV service delivery cascades (including the proportion of SSP participants receiving HIV testing and referrals to appropriate clinical services for HIV prevention and treatment) compared to IAU?
• What are the costs associated with SAIA-SSP-HIV and how cost-effective is the strategy? The trial will take place over 21 months and consist of a 3-month lead-in period, a 12-month active period, and a 6-month sustainment period. During the 12-month active period a SAIA specialist will meet with SSPs randomized to the SAIA-SSP-HIV arm to help them optimize their HIV service delivery cascades. Researchers will compare the SAIA-SSP-HIV and IAU arms to see if HIV service delivery and costs and cost-effectiveness differ by group.

Conditions

HIV Infections

Keywords

Systems Analysis; Preventative Health Services; Pre-Exposure Prophylaxis; Costs and Cost Analysis; Diagnostic Screening Programs; Syringe Service Programs; Randomized Controlled Clinical Trial; Multicenter Study; Health Services Research; Facilities and Services Utilization; Retention in Care; Implementation Science; Narcotic-Related Disorders; Infectious Disease Transmission; Communicable Disease; Substance-Related Disorders

Outcome Measures

Primary Outcomes (3)

• Effectiveness

  * 1(a) HIV Testing (Aim 1, Reach): Number of SSP participants tested for HIV, accounting for the total number of SSP participants. * 1(b) Total Referrals to Appropriate Clinical Services for HIV Prevention and Treatment (Aim 1, Fidelity to the cascade): Number of SSP participants referred to appropriate clinical services for HIV prevention and treatment, accounting for the number of SSP participants tested for HIV.

  12 months

• Sustained Effectiveness

  * 2(a) HIV Testing (Aim 2, Reach): Number of SSP participants tested for HIV, accounting for the total number of SSP participants. * 2(b) Total Referrals to Appropriate Clinical Services for HIV Prevention and Treatment (Aim 2, Fidelity to the cascade): Number of SSP participants referred to appropriate clinical services for HIV prevention and treatment, accounting for the number of SSP participants tested for HIV.

  18 months

• Costing

  * 3(a) Cost (Aim 3): Dollar amount of cost estimates associated with SAIA-HIV-SSP at the SSP level. * 3(b) Cost-Effectiveness (Aim 3): The ratio of the difference in costs to the difference in outcomes between study groups.

  18 months

Study Arms (2)

SAIA-SSP-HIV

EXPERIMENTAL

SAIA-SSP-HIV is an intervention that facilitates an organizational, SSP-level analysis of the delivery of HIV services by assigning a trained SAIA specialist to apply tools and techniques and engage staff to define barriers, identify solutions, and evaluate their success in cycles until achieving desired change regarding HIV service delivery. The scientific premise of this RCT is that SAIA will effectively boost and extend HIV service delivery cascades within SSPs assigned to the SAIA-SSP-HIV intervention condition (relative to IAU). SAIA specialists will meet with SSP staff biweekly for the first 3 months and then once monthly for the remaining 9 months during the 12-month intervention period.

Other: SAIA-HIV-SSP

Implementation as usual

NO INTERVENTION

SSPs randomized to the IAU arm will not receive support from a SAIA specialist. Though many SSPs in the US already offer HIV services, the investigators are testing the ability of SAIA-SSP-HIV to optimize the delivery of HIV services within SSPs. As such, the IAU condition is characterized by the absence of SAIA-SSP-HIV with the goal of comparing whether SAIA-SSP-HIV improves SSPs' HIV service delivery cascades.

Interventions

SAIA-HIV-SSP OTHER

The Systems Analysis and Improvement Approach (SAIA) is an evidence-based, multicomponent implementation strategy for improving the delivery of appropriate clinical services for HIV prevention and treatment. It involves five cyclical steps including (1) analyzing service delivery data to identify priority areas for system improvements, (2) mapping processes and building consensus around programmatic modifications to address priority areas, (3) implementing programmatic modifications, (4) assessing effects of programmatic modifications on improving delivery of services across the cascade, and (5) repeating steps 1-4 as needed.

SAIA-SSP-HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Organization operates within the United States, U.S. territory, or Tribal Nation.
• Organization operates a dedicated syringe service program (SSP) that provides access to sterile syringes and injection equipment for people who inject drugs (PWID).
• In the past 30 days, SSP staff have directly provided HIV counseling and testing services to SSP participants.

You may not qualify if:

• Organization is participating in or has participated in other studies involving SAIA or components of SAIA.
• Organization intends to stop providing HIV counseling and testing services to SSP participants within 21 months of their respective start date.

Sponsors & Collaborators

• University of California, San Diego: lead
• Drexel University: collaborator
• RTI International: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

Related Publications (11)

• Maki M, Jarvinen N, Rabina J, Roos C, Maaheimo H, Renkonen R; Pirkko; Mattila. Functional expression of Pseudomonas aeruginosa GDP-4-keto-6-deoxy-D-mannose reductase which synthesizes GDP-rhamnose. Eur J Biochem. 2002 Jan;269(2):593-601. doi: 10.1046/j.0014-2956.2001.02688.x.

  PMID: 11856318 BACKGROUND

• Bazzi AR, Biancarelli DL, Childs E, Drainoni ML, Edeza A, Salhaney P, Mimiaga MJ, Biello KB. Limited Knowledge and Mixed Interest in Pre-Exposure Prophylaxis for HIV Prevention Among People Who Inject Drugs. AIDS Patient Care STDS. 2018 Dec;32(12):529-537. doi: 10.1089/apc.2018.0126. Epub 2018 Oct 11.

  PMID: 30311777 BACKGROUND

• Biello KB, Bazzi AR, Vahey S, Harris M, Shaw L, Brody J. Delivering Preexposure Prophylaxis to People Who Use Drugs and Experience Homelessness, Boston, MA, 2018-2020. Am J Public Health. 2021 Jun;111(6):1045-1048. doi: 10.2105/AJPH.2021.306208.

  PMID: 33950728 BACKGROUND

• Biello KB, Bazzi AR, Mimiaga MJ, Biancarelli DL, Edeza A, Salhaney P, Childs E, Drainoni ML. Perspectives on HIV pre-exposure prophylaxis (PrEP) utilization and related intervention needs among people who inject drugs. Harm Reduct J. 2018 Nov 12;15(1):55. doi: 10.1186/s12954-018-0263-5.

  PMID: 30419926 BACKGROUND

• Biello KB, Mimiaga MJ, Valente PK, Saxena N, Bazzi AR. The Past, Present, and Future of PrEP implementation Among People Who Use Drugs. Curr HIV/AIDS Rep. 2021 Aug;18(4):328-338. doi: 10.1007/s11904-021-00556-z. Epub 2021 Apr 27.

  PMID: 33907971 BACKGROUND

• Brody JK, Taylor J, Biello K, Bazzi AR. Towards equity for people who inject drugs in HIV prevention drug trials. Int J Drug Policy. 2021 Oct;96:103284. doi: 10.1016/j.drugpo.2021.103284. Epub 2021 Jun 3. No abstract available.

  PMID: 34092469 BACKGROUND

• Earlywine JJ, Bazzi AR, Biello KB, Klevens RM. High Prevalence of Indications for Pre-exposure Prophylaxis Among People Who Inject Drugs in Boston, Massachusetts. Am J Prev Med. 2021 Mar;60(3):369-378. doi: 10.1016/j.amepre.2020.09.011. Epub 2020 Nov 21.

  PMID: 33229144 BACKGROUND

• Edeza A, Bazzi A, Salhaney P, Biancarelli D, Childs E, Mimiaga MJ, Drainoni ML, Biello K. HIV Pre-exposure Prophylaxis for People Who Inject Drugs: The Context of Co-occurring Injection- and Sexual-Related HIV Risk in the U.S. Northeast. Subst Use Misuse. 2020;55(4):525-533. doi: 10.1080/10826084.2019.1673419. Epub 2019 Oct 9.

  PMID: 31596171 BACKGROUND

• Felsher M, Ziegler E, Smith LR, Sherman SG, Amico KR, Fox R, Madden K, Roth AM. An Exploration of Pre-exposure Prophylaxis (PrEP) Initiation Among Women Who Inject Drugs. Arch Sex Behav. 2020 Aug;49(6):2205-2212. doi: 10.1007/s10508-020-01684-0. Epub 2020 Apr 9.

  PMID: 32274742 BACKGROUND

• Roth AM, Tran NK, Felsher M, Gadegbeku AB, Piecara B, Fox R, Krakower DS, Bellamy SL, Amico KR, Benitez JA, Van Der Pol B. Integrating HIV Preexposure Prophylaxis With Community-Based Syringe Services for Women Who Inject Drugs: Results From the Project SHE Demonstration Study. J Acquir Immune Defic Syndr. 2021 Mar 1;86(3):e61-e70. doi: 10.1097/QAI.0000000000002558.

  PMID: 33148998 BACKGROUND

• Bazzi AR, Roth AM, Akiba CF, Huffaker SL, Patel SV, Smith J, Laurano R, Orme S, Zarkin GA, Morgan-Lopez A, Lambdin BH. A systems analysis and improvement approach to optimizing syringe services programs' delivery of HIV testing and referrals: Study protocol for a parallel-group randomized controlled trial (SAIA-SSP-HIV). PLoS One. 2025 Feb 25;20(2):e0319340. doi: 10.1371/journal.pone.0319340. eCollection 2025.

  PMID: 39999129 DERIVED

MeSH Terms

Conditions

HIV Infections; Narcotic-Related Disorders; Communicable Diseases; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexis M Roth, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

• Barrot H Lambdin, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: September 6, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)