xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06025435</url>
    </required_header>
    <id_info>
      <org_study_id>38233</org_study_id>
      <secondary_id>R01DA056883</secondary_id>
      <nct_id>NCT06025435</nct_id>
    </id_info>
    <brief_title>A Systems Analysis and Improvement Approach for Optimizing HIV Service Delivery in Syringe Service Programs</brief_title>
    <acronym>SAIA-HIV</acronym>
    <official_title>SAIA-HIV: a Systems Analysis and Improvement Approach to Optimizing HIV Service Delivery in Syringe Service Programs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Diego</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Drexel University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>RTI International</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Diego</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess the effectiveness of an evidence-based,&#xD;
        organizational-level implementation strategy, the Systems Analysis and Improvement Approach,&#xD;
        in improving HIV service delivery (SAIA-HIV) in U.S. syringe service programs (SSPs). The&#xD;
        main questions it aims to answer are:&#xD;
  &#xD;
          -  Does SAIA-HIV improve delivery of HIV services (including the proportions of SSP clients&#xD;
             receiving HIV testing) compared to implementation as usual (IAU)?&#xD;
  &#xD;
          -  Does SAIA-HIV result in sustained improvement of HIV service delivery cascades&#xD;
             (including the proportions of SSP clients receiving HIV testing) compared to IAU?&#xD;
  &#xD;
          -  What are the costs associated with SAIA-HIV and how cost-effective is the strategy?&#xD;
  &#xD;
        The trial will take place over 21 months and consist of a 3-month lead-in period, a 12-month&#xD;
        active period, and a 6-month sustainment period. During the 12-month active period a SAIA&#xD;
        specialist will meet with SSPs randomized to the SAIA-HIV arm to help them optimize their HIV&#xD;
        service delivery cascades. Researchers will compare the SAIA-HIV and IAU arms to see if HIV&#xD;
        service delivery and costs and cost-effectiveness differ by group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators plan to examine SAIA-HIV's impact on SSPs compared to an&#xD;
        implementation-as-usual (IAU) condition across 3 aims and several related hypotheses. Data&#xD;
        collection will take place monthly across 21 months of SSP participation. These 21 months&#xD;
        include a 3-month lead-in period to establish SSP outcome data characteristics, the 12-month&#xD;
        intervention period during which sites randomized to SAIA-HIV will meet with the SAIA&#xD;
        specialist, and an additional 6 months (sustainment period) to determine whether impacts are&#xD;
        sustained.&#xD;
  &#xD;
          -  Aim 1. The first aim of the study is to assess the effectiveness of SAIA-HIV. The&#xD;
             investigators hypothesize that compared with SSPs receiving IAU, SSPs receiving SAIA-HIV&#xD;
             will significantly increase the proportions of SSP clients receiving HIV testing over 12&#xD;
             months.&#xD;
  &#xD;
          -  Aim 2. The second aim of the study is to assess the sustained effectiveness of SAIA-HIV.&#xD;
             The investigators hypothesize that compared with SSPs that received IAU, SSPs that&#xD;
             received SAIA-HIV will report significantly higher proportions of SSP clients receiving&#xD;
             HIV testing at 18 months.&#xD;
  &#xD;
          -  Aim 3. The third aim of the study is to assess the costs and cost-effectiveness of&#xD;
             SAIA-HIV on improving HIV service delivery cascades at SSPs, relative to IAU. The&#xD;
             investigators hypothesize that, compared to SSPs that received IAU, SSPs that received&#xD;
             SAIA-HIV will be cost-effective at increasing the proportions of SSP clients receiving&#xD;
             HIV testing.&#xD;
  &#xD;
        To meet these aims, the investigators plan to conduct a randomized controlled interrupted&#xD;
        time series trial among 32 U.S. SSPs (n=16 will be randomly assigned to the SAIA-HIV arm and&#xD;
        n=16 to the IAU arm). SSPs randomized to the IAU arm will not receive support from a SAIA-HIV&#xD;
        specialist. As such, the IAU condition is characterized by the absence of SAIA-HIV with the&#xD;
        goal of comparing whether SAIA-HIV improves SSPs' HIV service delivery cascade.&#xD;
  &#xD;
        Preliminary research has demonstrated the need for increased HIV services at SSPs and the&#xD;
        acceptability, facilitators, and feasibility of HIV service implementation at SSPs. To the&#xD;
        investigators' knowledge, this will be the first randomized controlled trial (RCT) of an&#xD;
        organizational-level intervention to optimize the SSP-based HIV service delivery cascade. If&#xD;
        successful, SAIA could be disseminated to the ≥430 SSPs nationally and in global settings,&#xD;
        carrying the potential for exceptional impact amidst persistent HIV transmission in people&#xD;
        who inject drugs (PWID).&#xD;
  &#xD;
        The primary contact at each SSP will be asked about basic organizational characteristics&#xD;
        (location, number of staff, budget, etc.). Next, the primary contacts as well as other staff&#xD;
        involved with HIV service delivery at each SSP will be asked about contextual variables such&#xD;
        as implementation climate for improving the HIV service delivery cascade. Quality control and&#xD;
        monitoring of SAIA fidelity will include reviewing the SAIA management database for content,&#xD;
        which will contain key information regarding SAIA specialists' delivery of the SAIA&#xD;
        intervention to SSPs (e.g., date, service type and length, activity and name of SAIA&#xD;
        specialist). These will be reviewed by the Project Director and Multiple Principal&#xD;
        Investigators (MPIs). Quarterly, this team will also review meeting frequency, cross-checking&#xD;
        the encounter log with dates of recorded sessions, and content by reviewing 20% of meetings&#xD;
        randomly selected from that quarter. If necessary, additional training and supervision will&#xD;
        be conducted with the SAIA specialists. For SSPs in the SAIA arm, the investigators will&#xD;
        routinely collect the number of SAIA cycles and the content and impact of programmatic&#xD;
        changes from months 4 through 21 to allow for observation of activities during SAIA delivery&#xD;
        and post-SAIA delivery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Effectiveness</measure>
      <time_frame>12 months</time_frame>
      <description>1(a) HIV Testing (Aim 1, Reach): Number of SSP participants tested for HIV, accounting for the total number of SSP participants.&#xD;
  1(b) Total Referrals to Appropriate Clinical Services (Aim 1, Fidelity to the cascade): Number of SSP participants referred to appropriate clinical services, accounting for the number of SSP participants tested for HIV.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sustained Effectiveness</measure>
      <time_frame>18 months</time_frame>
      <description>2(a) HIV Testing (Aim 2, Reach): Number of SSP participants tested for HIV, accounting for the total number of SSP participants.&#xD;
  2(b) Total Referrals to Appropriate Clinical Services (Aim 2, Fidelity to the cascade): Number of SSP participants referred to appropriate clinical services, accounting for the number of SSP participants tested for HIV.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Costing</measure>
      <time_frame>18 months</time_frame>
      <description>3(a) Cost (Aim 3): Dollar amount of cost estimates associated with SAIA-HIV at the SSP level.&#xD;
  3(b) Cost-Effectiveness (Aim 3): The ratio of the difference in costs to the difference in outcomes between study groups.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>HIV Infections</condition>
    <arm_group>
      <arm_group_label>SAIA-HIV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SAIA-HIV is an intervention that facilitates an organizational, SSP-level analysis of the delivery of HIV services by assigning a trained SAIA-HIV 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-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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Implementation as usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>SSPs randomized to the IAU arm will not receive support from a SAIA-HIV specialist. Though many SSPs in the US already offer HIV services, the investigators are testing the ability of SAIA-HIV to optimize delivery of HIV services within SSPs. As such, the IAU condition is characterized by the absence of SAIA-HIV with the goal of comparing whether SAIA-HIV improves SSPs' HIV service delivery cascade.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>SAIA-HIV</intervention_name>
      <description>The Systems Analysis and Improvement Approach (SAIA) is an evidence-based, multicomponent implementation strategy for improving the delivery of HIV prevention services. 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.</description>
      <arm_group_label>SAIA-HIV</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Organization operates within the United States, U.S. territory, or Tribal Nation.&#xD;
  &#xD;
            -  Organization operates a dedicated syringe service program (SSP) that provides access&#xD;
               to sterile syringes and injection equipment for people who inject drugs (PWID).&#xD;
  &#xD;
            -  In the past 30 days, SSP staff have directly provided HIV counseling and testing&#xD;
               services to SSP participants.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Organization is participating or has participated in the SAIA-Naloxone trial or other&#xD;
               studies involving SAIA.&#xD;
  &#xD;
            -  Organization intends to stop providing HIV counseling and testing services to SSP&#xD;
               participants within the next 18 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexis M Roth, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Drexel University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Barrot H Lambdin, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>RTI International</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Angela R Bazzi, PhD, MPH</last_name>
      <phone>8582463612</phone>
      <email>abazzi@health.ucsd.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shelby L Huffaker, MPH</last_name>
      <phone>8582461039</phone>
      <email>shhuffaker@health.ucsd.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>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.</citation>
      <PMID>30311777</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33950728</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>30419926</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33907971</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>34092469</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33229144</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>31596171</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>32274742</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33148998</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, San Diego</investigator_affiliation>
      <investigator_full_name>Angela Bazzi</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Systems Analysis</keyword>
    <keyword>Preventative Health Services</keyword>
    <keyword>Pre-Exposure Prophylaxis</keyword>
    <keyword>Costs and Cost Analysis</keyword>
    <keyword>Diagnostic Screening Programs</keyword>
    <keyword>Syringe Service Programs</keyword>
    <keyword>Randomized Controlled Clinical Trial</keyword>
    <keyword>Multicenter Study</keyword>
    <keyword>Health Services Research</keyword>
    <keyword>Facilities and Services Utilization</keyword>
    <keyword>Retention in Care</keyword>
    <keyword>Implementation Science</keyword>
    <keyword>Narcotic-Related Disorders</keyword>
    <keyword>Infectious Disease Transmission</keyword>
    <keyword>Communicable Disease</keyword>
    <keyword>Substance-Related Disorders</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06025435
  org study id: 38233
  secondary id: R01DA056883
  nct id: NCT06025435
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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-HIV) in U.S. syringe service programs (SSPs). The
        main questions it aims to answer are:
  
          -  Does SAIA-HIV improve delivery of HIV services (including the proportions of SSP clients
             receiving HIV testing) compared to implementation as usual (IAU)?
  
          -  Does SAIA-HIV result in sustained improvement of HIV service delivery cascades
             (including the proportions of SSP clients receiving HIV testing) compared to IAU?
  
          -  What are the costs associated with SAIA-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-HIV arm to help them optimize their HIV
        service delivery cascades. Researchers will compare the SAIA-HIV and IAU arms to see if HIV
        service delivery and costs and cost-effectiveness differ by group.
  The investigators plan to examine SAIA-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-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-HIV. The
             investigators hypothesize that compared with SSPs receiving IAU, SSPs receiving SAIA-HIV
             will significantly increase the proportions of SSP clients receiving HIV testing over 12
             months.
  
          -  Aim 2. The second aim of the study is to assess the sustained effectiveness of SAIA-HIV.
             The investigators hypothesize that compared with SSPs that received IAU, SSPs that
             received SAIA-HIV will report significantly higher proportions of SSP clients receiving
             HIV testing at 18 months.
  
          -  Aim 3. The third aim of the study is to assess the costs and cost-effectiveness of
             SAIA-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-HIV will be cost-effective at increasing the proportions of SSP clients receiving
             HIV testing.
  
        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-HIV arm and
        n=16 to the IAU arm). SSPs randomized to the IAU arm will not receive support from a SAIA-HIV
        specialist. As such, the IAU condition is characterized by the absence of SAIA-HIV with the
        goal of comparing whether SAIA-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). These will be reviewed by the Project Director and Multiple Principal
        Investigators (MPIs). Quarterly, this team will also review meeting frequency, cross-checking
        the encounter log with dates of recorded sessions, and content by reviewing 20% of meetings
        randomly selected from that quarter. If necessary, additional training and supervision will
        be conducted with the SAIA specialists. For SSPs in the SAIA arm, the investigators will
        routinely collect the number of SAIA cycles and the content and impact of programmatic
        changes from months 4 through 21 to allow for observation of activities during SAIA delivery
        and post-SAIA delivery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Effectiveness
  time frame: 12 months
  description: 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 (Aim 1, Fidelity to the cascade): Number of SSP participants referred to appropriate clinical services, accounting for the number of SSP participants tested for HIV.
  measure: Sustained Effectiveness
  time frame: 18 months
  description: 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 (Aim 2, Fidelity to the cascade): Number of SSP participants referred to appropriate clinical services, accounting for the number of SSP participants tested for HIV.
  measure: Costing
  time frame: 18 months
  description: 3(a) Cost (Aim 3): Dollar amount of cost estimates associated with SAIA-HIV 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.
  arm group label: SAIA-HIV
  arm group type: Experimental
  description: SAIA-HIV is an intervention that facilitates an organizational, SSP-level analysis of the delivery of HIV services by assigning a trained SAIA-HIV 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-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.
  arm group label: Implementation as usual
  arm group type: No Intervention
  description: SSPs randomized to the IAU arm will not receive support from a SAIA-HIV specialist. Though many SSPs in the US already offer HIV services, the investigators are testing the ability of SAIA-HIV to optimize delivery of HIV services within SSPs. As such, the IAU condition is characterized by the absence of SAIA-HIV with the goal of comparing whether SAIA-HIV improves SSPs' HIV service delivery cascade.
  intervention type: Other
  intervention name: SAIA-HIV
  description: The Systems Analysis and Improvement Approach (SAIA) is an evidence-based, multicomponent implementation strategy for improving the delivery of HIV prevention services. 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.
  arm group label: SAIA-HIV
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alexis M Roth, PhD
  role: Principal Investigator
  affiliation: Drexel University
  last name: Barrot H Lambdin, PhD
  role: Principal Investigator
  affiliation: RTI International
  last name: Angela R Bazzi, PhD, MPH
  phone: 8582463612
  email: abazzi@health.ucsd.edu
  last name: Shelby L Huffaker, MPH
  phone: 8582461039
  email: shhuffaker@health.ucsd.edu
  citation: 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
  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.
  PMID: 33950728
  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.
  PMID: 30419926
  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.
  PMID: 33907971
  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.
  PMID: 34092469
  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.
  PMID: 33229144
  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.
  PMID: 31596171
  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.
  PMID: 32274742
  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.
  PMID: 33148998
  responsible party type: Principal Investigator
  investigator affiliation: University of California, San Diego
  investigator full name: Angela Bazzi
  investigator title: Associate Professor
  mesh term: HIV Infections
  sharing ipd: No