HIV InfectionsSAIA-SSP-HIVNCT06025435
A Systems Analysis and Improvement Approach for Optimizing HIV Service Delivery in Syringe Services Programs
A study testing SAIA-HIV-SSP in people with HIV Infections, run by University of California, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- SAIA-HIV-SSP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
Official 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 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.
Read the detailed description
The investigators plan to examine SAIA-SSP-HIV's impact on SSPs compared to an implementation-as-usual (IAU) condition across 3 aims and several related hypotheses. Data collection will take place monthly across 21 months of SSP participation. These 21 months include a 3-month lead-in period to establish SSP outcome data characteristics, the 12-month intervention period during which sites randomized to SAIA-SSP-HIV will meet with the SAIA specialist, and an additional 6 months (sustainment period) to determine whether impacts are sustained.
- Aim 1. The first aim of the study is to assess the effectiveness of SAIA-SSP-HIV. The investigators hypothesize that compared with SSPs receiving IAU, SSPs receiving SAIA-SSP-HIV will significantly increase the proportion of SSP participants receiving HIV testing and referrals to appropriate clinical services for HIV prevention and treatment over 12 months.
- Aim 2. The second aim of the study is to assess the sustained effectiveness of SAIA-SSP-HIV. The investigators hypothesize that compared with SSPs that received IAU, SSPs that received SAIA-SSP-HIV will report a significantly higher proportion of SSP participants receiving HIV testing and referrals to appropriate clinical services for HIV prevention and treatment at 18 months.
- Aim 3. The third aim of the study is to assess the costs and cost-effectiveness of SAIA-SSP-HIV on improving HIV service delivery cascades at SSPs, relative to IAU. The investigators hypothesize that, compared to SSPs that received IAU, SSPs that received SAIA-SSP-HIV will be cost-effective at increasing the proportion of SSP participants receiving HIV testing and referrals to appropriate clinical services for HIV prevention and treatment.
To meet these aims, the investigators plan to conduct a randomized controlled interrupted time series trial among 32 U.S. SSPs (n=16 will be randomly assigned to the SAIA-SSP-HIV arm and n=16 to the IAU arm). SSPs randomized to the IAU arm will not receive support from a SAIA-SSP-HIV specialist. 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 cascade.
Preliminary research has demonstrated the need for increased HIV services at SSPs and the acceptability, facilitators, and feasibility of HIV service implementation at SSPs. To the investigators' knowledge, this will be the first randomized controlled trial (RCT) of an organizational-level intervention to optimize the SSP-based HIV service delivery cascade. If successful, SAIA could be disseminated to the ≥430 SSPs nationally and in global settings, carrying the potential for exceptional impact amidst persistent HIV transmission in people who inject drugs (PWID).
The primary contact at each SSP will be asked about basic organizational characteristics (location, number of staff, budget, etc.). Next, the primary contacts as well as other staff involved with HIV service delivery at each SSP will be asked about contextual variables such as implementation climate for improving the HIV service delivery cascade. Quality control and monitoring of SAIA fidelity will include reviewing the SAIA management database for content, which will contain key information regarding SAIA specialists' delivery of the SAIA intervention to SSPs (e.g., date, service type and length, activity and name of SAIA specialist). The database will be reviewed during weekly meetings between the SAIA specialists and the study coordinator. Additionally, the SAIA specialists and study coordinator will review implementation efforts by completing periodic reflections on a monthly basis. If necessary, additional training and supervision will be conducted with the SAIA specialists. For SSPs in the SAIA arm, the investigators will routinely collect data on the number of SAIA cycles and the content and impact of programmatic changes during the active and sustainment periods to allow for observation of activities during and after SAIA delivery.
- Conditions
- HIV Infections
- Being tested
- SAIA-HIV-SSP
- 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
- Medical subject headings
- HIV Infections, Narcotic-Related Disorders, Communicable Diseases, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAIA-HIV-SSPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Dec 2023
- Primary completionSep 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel University, RTI International, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Angela Bazzi, University of California, San Diego
- Investigators
- Alexis M Roth, PhD, Principal investigator, Drexel UniversityBarrot H Lambdin, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025435
- Sponsor's protocol ID
- 38233
- Other IDs
- R01DA056883
- Acronym
- SAIA-SSP-HIV
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39999129Bazzi 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.
PubMed 30311777Biello 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.
PubMed 33950728Biello 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.
PubMed 30419926Biello 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.
PubMed 33907971Brody 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.
PubMed 34092469Earlywine 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.
PubMed 33229144Edeza 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.
PubMed 31596171Felsher 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.
PubMed 32274742Roth 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.
PubMed 33148998Forman E, Eger WH, Akiba CF, Patel SV, Huffaker SL, Smith J, Lambdin BH, Roth AM, R Bazzi A. Operationalizing recipient-centeredness: three facets of values-driven care in syringe services programs. Implement Sci Commun. 2026 Jul 28;7(1):185. doi: 10.1186/s43058-026-01051-5.
PubMed 42723129Eger WH, Huffaker SL, Forman E, Smith J, Akiba CF, Laurano R, Patel SV, Lambdin BH, Roth AM, Bazzi AR. Integration of safer smoking equipment in U.S. syringe services programs: Qualitative insights from program staff. Int J Drug Policy. 2026 Jan;147:105106. doi: 10.1016/j.drugpo.2025.105106. Epub 2025 Dec 9.
PubMed 41371077
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAIA-SSP-HIV: a Systems Analysis and Improvement Approach to Optimizing HIV Service Delivery in Syringe Services Programs
- ClinicalTrials.gov ID
- NCT06025435
- Acronym / sponsor ID
- SAIA-SSP-HIV / 38233
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Drexel University, RTI International, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators plan to examine SAIA-SSP-HIV's impact on SSPs compared to an implementation-as-usual (IAU) condition across 3 aims and several related hypotheses. Data collection will take place monthly across 21 months of SSP participation. These 21 months include a 3-month lead-in period to establish SSP outcome data characteristics, the 12-month intervention period during which sites randomized to SAIA-SSP-HIV will meet with the SAIA specialist, and an additional 6 months (sustainment period) to determine whether impacts are sustained.
- Aim 1. The first aim of the study is to assess the effectiveness of SAIA-SSP-HIV. The investigators hypothesize that compared with SSPs receiving IAU, SSPs receiving SAIA-SSP-HIV will significantly increase the proportion of SSP participants receiving HIV testing and referrals to appropriate clinical services for HIV prevention and treatment over 12 months.
- Aim 2. The second aim of the study is to assess the sustained effectiveness of SAIA-SSP-HIV. The investigators hypothesize that compared with SSPs that received IAU, SSPs that received SAIA-SSP-HIV will report a significantly higher proportion of SSP participants receiving HIV testing and referrals to appropriate clinical services for HIV prevention and treatment at 18 months.
- Aim 3. The third aim of the study is to assess the costs and cost-effectiveness of SAIA-SSP-HIV on improving HIV service delivery cascades at SSPs, relative to IAU. The investigators hypothesize that, compared to SSPs that received IAU, SSPs that received SAIA-SSP-HIV will be cost-effective at increasing the proportion of SSP participants receiving HIV testing and referrals to appropriate clinical services for HIV prevention and treatment.
To meet these aims, the investigators plan to conduct a randomized controlled interrupted time series trial among 32 U.S. SSPs (n=16 will be randomly assigned to the SAIA-SSP-HIV arm and n=16 to the IAU arm). SSPs randomized to the IAU arm will not receive support from a SAIA-SSP-HIV specialist. 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 cascade.
Preliminary research has demonstrated the need for increased HIV services at SSPs and the acceptability, facilitators, and feasibility of HIV service implementation at SSPs. To the investigators' knowledge, this will be the first randomized controlled trial (RCT) of an organizational-level intervention to optimize the SSP-based HIV service delivery cascade. If successful, SAIA could be disseminated to the ≥430 SSPs nationally and in global settings, carrying the potential for exceptional impact amidst persistent HIV transmission in people who inject drugs (PWID).
The primary contact at each SSP will be asked about basic organizational characteristics (location, number of staff, budget, etc.). Next, the primary contacts as well as other staff involved with HIV service delivery at each SSP will be asked about contextual variables such as implementation climate for improving the HIV service delivery cascade. Quality control and monitoring of SAIA fidelity will include reviewing the SAIA management database for content, which will contain key information regarding SAIA specialists' delivery of the SAIA intervention to SSPs (e.g., date, service type and length, activity and name of SAIA specialist). The database will be reviewed during weekly meetings between the SAIA specialists and the study coordinator. Additionally, the SAIA specialists and study coordinator will review implementation efforts by completing periodic reflections on a monthly basis. If necessary, additional training and supervision will be conducted with the SAIA specialists. For SSPs in the SAIA arm, the investigators will routinely collect data on the number of SAIA cycles and the content and impact of programmatic changes during the active and sustainment periods to allow for observation of activities during and after SAIA delivery.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAIA-SSP-HIV | Experimental | Other: SAIA-HIV-SSPSAIA-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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| SAIA-HIV-SSPThe 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. | Other | SAIA-SSP-HIV |
Primary outcome
Effectiveness
Time frame: 12 months
* 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.
Sustained Effectiveness
Time frame: 18 months
* 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.
Costing
Time frame: 18 months
* 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 39999129Bazzi 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.
- Background: PubMed 30311777Bazzi 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.
- Background: PubMed 33950728Biello 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.
- Background: PubMed 30419926Biello 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.
- Background: PubMed 33907971Biello 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.
- Background: PubMed 34092469Brody 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.
- Background: PubMed 33229144Earlywine 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.
- Background: PubMed 31596171Edeza 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.
- Background: PubMed 32274742Felsher 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.
- Background: PubMed 33148998Roth 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.
- Derived from this study: PubMed 42723129Forman E, Eger WH, Akiba CF, Patel SV, Huffaker SL, Smith J, Lambdin BH, Roth AM, R Bazzi A. Operationalizing recipient-centeredness: three facets of values-driven care in syringe services programs. Implement Sci Commun. 2026 Jul 28;7(1):185. doi: 10.1186/s43058-026-01051-5.
- Derived from this study: PubMed 41371077Eger WH, Huffaker SL, Forman E, Smith J, Akiba CF, Laurano R, Patel SV, Lambdin BH, Roth AM, Bazzi AR. Integration of safer smoking equipment in U.S. syringe services programs: Qualitative insights from program staff. Int J Drug Policy. 2026 Jan;147:105106. doi: 10.1016/j.drugpo.2025.105106. Epub 2025 Dec 9.
- Individual participant dataSharing planned: No
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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.
Alexis M Roth, PhD principal investigator
Drexel University
Barrot H Lambdin, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAIA-HIV-SSP in people with HIV Infections, run by University of California, San Diego 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Effectiveness (time frame: 12 months). The study lists 3 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 NCT06025435, which also lists 12 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 24 Aug 2026.