SAIA-HIV: A Systems Analysis and Improvement Approach for Optimizing HIV Service Delivery in Syringe Service Programs

Sponsor

University of California, San Diego (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06025435

Collaborator

Drexel University (Other), RTI International (Other), National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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-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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Other: SAIA-HIV	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAIA-HIV 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.	Other: SAIA-HIV 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.
No Intervention: Implementation as usual 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.

Arm

Intervention/Treatment

Experimental: SAIA-HIV

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.

Other: SAIA-HIV

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.

No Intervention: Implementation as usual

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.

Outcome Measures

Primary Outcome Measures

Effectiveness [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 (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.
Sustained Effectiveness [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 (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.
Costing [18 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 or has participated in the SAIA-Naloxone trial or other studies involving SAIA.
Organization intends to stop providing HIV counseling and testing services to SSP participants within the next 18 months.