HIV Infections Clinical Trial
— SAIA-SSP-HIVOfficial title:
SAIA-SSP-HIV: a Systems Analysis and Improvement Approach to Optimizing HIV Service Delivery in Syringe Services Programs
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) 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) 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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Drexel University, National Institute on Drug Abuse (NIDA), RTI International |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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