Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Angela Bazzi (ucsd)
Headshot of Angela Bazzi
Angela Bazzi

Description

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-HIV-SSP) in U.S. syringe services programs (SSPs). The main questions it aims to answer are:

  • Does SAIA-HIV-SSP improve delivery of HIV services (including the proportion of SSP participants receiving HIV testing) compared to implementation as usual (IAU)?
  • Does SAIA-HIV-SSP 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-HIV-SSP 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-SSP arm to help them optimize their HIV service delivery cascades. Researchers will compare the SAIA-HIV-SSP and IAU arms to see if HIV service delivery and costs and cost-effectiveness differ by group.

Official Title

SAIA-HIV: a Systems Analysis and Improvement Approach to Optimizing HIV Service Delivery in Syringe Services Programs

Details

The investigators plan to examine SAIA-HIV-SSP'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-SSP 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-SSP. The investigators hypothesize that compared with SSPs receiving IAU, SSPs receiving SAIA-HIV-SSP will significantly increase the proportion of SSP participants receiving HIV testing over 12 months.
  • Aim 2. The second aim of the study is to assess the sustained effectiveness of SAIA-HIV-SSP. The investigators hypothesize that compared with SSPs that received IAU, SSPs that received SAIA-HIV-SSP will report a significantly higher proportion of SSP participants 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-SSP 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-SSP will be cost-effective at increasing the proportion of SSP participants 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-SSP arm and n=16 to the IAU arm). SSPs randomized to the IAU arm will not receive support from a SAIA-HIV-SSP specialist. As such, the IAU condition is characterized by the absence of SAIA-HIV-SSP with the goal of comparing whether SAIA-HIV-SSP 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.

Keywords

HIV Infections, 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, SAIA-HIV-SSP

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Location

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States

Lead Scientist at University of California Health

  • Angela Bazzi (ucsd)
    Associate Professor, Herbert Wertheim School of Public Health & Human Longevity Science, Vc-health Sciences-schools. Authored (or co-authored) 126 research publications. Research interests: HIV prevention · substance use · infectious diseases · qualitative research · mixed methods · implementation science

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06025435
Study Type
Interventional
Participants
Expecting 32 study participants
Last Updated