Active — Not RecruitingNot Applicable

A Systems Analysis and Improvement Approach for Optimizing HIV Service Delivery in Syringe Services Programs

United States32 participantsStarted 2023-12-01

Plain-language 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). 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effectiveness

Timeframe: 12 months

Sustained Effectiveness

Timeframe: 18 months

Costing

Timeframe: 18 months

Trial details

NCT IDNCT06025435

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More HIV Infections trials