Systems Analysis and Improvement Approach for HIV Service Delivery

(SAIA-SSP-HIV Trial)

Overseen By Shelby L Huffaker, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Other SAIA studies, Stop HIV services

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment SAIA-HIV-SSP for HIV service delivery?

The research on similar interventions, like the System Navigation and Psychosocial Counseling (SNaP) for people who inject drugs, shows improved HIV outcomes such as increased uptake of antiretroviral therapy and reduced mortality. This suggests that structured approaches to HIV service delivery, like SAIA-HIV-SSP, may also be effective in improving care for people living with HIV. ^{1 2 3 4 5}

How does the Systems Analysis and Improvement Approach (SAIA) treatment differ from other HIV treatments?

The Systems Analysis and Improvement Approach (SAIA) is unique because it uses systems engineering tools to improve the flow and efficiency of HIV service delivery, particularly for preventing mother-to-child transmission. Unlike traditional treatments that focus solely on medication, SAIA emphasizes understanding and fixing inefficiencies in healthcare processes to enhance overall treatment outcomes. ^{6 7 8 9 10}

What is the purpose of this trial?

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) 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) 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.

Research Team

Barrot H Lambdin, PhD

Principal Investigator

RTI International

Alexis M Roth, PhD

Principal Investigator

Drexel University

Eligibility Criteria

This trial is for organizations within the US, its territories, or Tribal Nations that run syringe service programs (SSPs) offering sterile syringes to drug users and have recently provided HIV counseling and testing. It's not specified who can't join.

Inclusion Criteria

The organization is based in the United States, its territories or a Tribal Nation.

Your organization runs a specialized SSP that supplies sterile syringes and injection equipment to PWID.

Over the past month, SSP personnel have administered HIV counseling and testing to program participants.

Timeline

Lead-in

Establish SSP outcome data characteristics

3 months

Monthly data collection

Active Intervention

SAIA specialists meet with SSPs to optimize HIV service delivery cascades

12 months

Biweekly meetings for 3 months, then monthly meetings for 9 months

Sustainment

Determine whether impacts of SAIA-SSP-HIV are sustained

6 months

Monthly data collection

Follow-up

Participants are monitored for sustained effectiveness and cost-effectiveness after intervention

18 months

Treatment Details

Interventions

• SAIA-HIV-SSP

Trial Overview The study tests an organizational strategy called SAIA-HIV-SSP aimed at improving HIV services in SSPs. It compares this approach with usual implementation over a period of 21 months to see if it increases HIV testing rates and is cost-effective.

Participant Groups

Group I: SAIA-SSP-HIV Experimental Treatment 1 Intervention

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.

Group II: Implementation as usual Active Control 1 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 Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

RTI International

Collaborator

Trials

201

Recruited

942,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study involving substance-abusing patients with HIV/AIDS, both brief contact and 12 months of case management led to significant improvements in various issues like substance use and psychological status within the first 6 months, but no lasting differences were observed at 12 and 18 months.

There was no evidence that the more intensive case management provided better outcomes than the brief contact, suggesting that simpler interventions may be equally effective for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case management for substance abusers with HIV/AIDS: a randomized clinical trial. Sorensen, JL., Dilley, J., London, J., et al.[2019]

The Community Follow-Up Program (CFP) in New York State provides intensive case management for HIV-positive individuals and their families, emphasizing the importance of tailored support in managing health outcomes.

Involving service providers in developing outcome indicators and measures has proven effective in overcoming resistance to outcomes assessment, ultimately leading to improved program performance based on two years of collected data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and implementation of an HIV/AIDS case management outcomes assessment programme. Lehrman, S., Gimbel, R., Freedman, J., et al.[2019]

This study will evaluate the effectiveness of two different approaches to scaling up the System Navigation and Psychosocial Counseling (SNaP) intervention for HIV-positive people who inject drugs (PWID) in Vietnam, involving 6200 participants across 42 HIV testing sites.

The trial aims to compare implementation outcomes (like fidelity and acceptability) and effectiveness outcomes (such as uptake of antiretroviral therapy and viral suppression) over 24 months, providing valuable insights into the most effective and cost-efficient methods for implementing SNaP interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial. Nguyen, MXB., Chu, AV., Powell, BJ., et al.[2021]

The combined Patient Navigation (PN) and Contingency Management (CM) intervention significantly improved self-efficacy for HIV treatment adherence among 801 hospitalized individuals living with HIV and substance use, leading to better engagement in HIV care at 6 months.

This intervention also resulted in increased rates of viral suppression at both 6 and 12 months, highlighting the importance of enhancing self-efficacy as a key mechanism for improving health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-efficacy as a mediator of patient navigation interventions to engage persons living with HIV and substance use. Traynor, SM., Metsch, LR., Gooden, L., et al.[2022]

The study evaluated the effectiveness of a hospital-based intervention for HIV-affected substance abusers, involving 86 participants over an 8-month period, and found that factors like source of referral and interest in treatment significantly influenced the success of the intervention.

Barriers to accessing treatment included personal unreadiness and long waiting lists for programs, highlighting the need for improved accessibility in substance abuse treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a hospital based substance abuse intervention and referral service for HIV affected patients. Guydish, J., Temoshok, L., Dilley, J., et al.[2019]

The SAIA-SCALE trial in Mozambique demonstrated that the Systems Analysis and Improvement Approach (SAIA) is compatible with the existing health system, which enhances its potential for scaling up interventions to prevent Mother-to-Child transmission of HIV.

Barriers to successful implementation included inadequate infrastructure and financial management at the district level, indicating that without addressing these issues, the scalability of SAIA may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing drivers of implementing "Scaling-up the Systems Analysis and Improvement Approach" for Prevention of Mother-to-Child HIV Transmission in Mozambique (SAIA-SCALE) over implementation waves. Inguane, C., Gimbel, S., Soi, C., et al.[2023]

The SAIA intervention, a five-step systems analysis and improvement approach, aims to enhance the effectiveness of mother-to-child HIV transmission prevention services in 90 health facilities across Côte d'Ivoire, Kenya, and Mozambique, focusing on reducing inefficiencies in service delivery.

This study employs a two-arm, longitudinal cluster randomized trial design to evaluate the impact of the SAIA intervention over six months, with primary outcomes including the percentage of pregnant women tested for HIV and the adequacy of prophylaxis for HIV-infected pregnant women, potentially leading to improved maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial. Sherr, K., Gimbel, S., Rustagi, A., et al.[2021]

The SAIA-SCALE trial aims to improve the prevention of mother-to-child HIV transmission (PMTCT) in Mozambique by using systems engineering tools to enhance healthcare workflows, with a focus on district nurse supervisors leading the intervention.

This trial will evaluate the effectiveness of the SAIA-SCALE model over three implementation waves, assessing its impact on PMTCT outcomes and the sustainability of the intervention across 36 health facilities in Manica province.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scaling-up the Systems Analysis and Improvement Approach for prevention of mother-to-child HIV transmission in Mozambique (SAIA-SCALE): a stepped-wedge cluster randomized trial. Sherr, K., Ásbjörnsdóttir, K., Crocker, J., et al.[2020]

The Systems Analysis and Improvement Approach (SAIA) study identified key components for improving mother-to-child transmission (PMTCT) programs, with flow mapping and continuous quality improvement being essential across all settings.

The study revealed that high-performing facilities had better networks, communication, and resources, highlighting the importance of these factors in successfully implementing PMTCT interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Systems Analysis and Improvement Approach to Optimize Prevention of Mother-To-Child Transmission of HIV Using the Consolidated Framework for Implementation Research. Gimbel, S., Rustagi, AS., Robinson, J., et al.[2020]

The SAIA-PEDS strategy, adapted for pediatric and adolescent HIV care in Kenya, showed significant improvements in viral load testing, indicating better health system performance in later stages of the HIV care cascade.

However, the strategy did not lead to substantial changes in HIV testing and linkage to care, suggesting that while it may enhance certain aspects of HIV management, further refinement is needed to improve initial testing and treatment initiation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systems Analysis and Improvement Approach to optimize the pediatric and adolescent HIV Cascade (SAIA-PEDS): a pilot study. Wagner, AD., Augusto, O., Njuguna, IN., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Case management for substance abusers with HIV/AIDS: a randomized clinical trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Development and implementation of an HIV/AIDS case management outcomes assessment programme. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Self-efficacy as a mediator of patient navigation interventions to engage persons living with HIV and substance use. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a hospital based substance abuse intervention and referral service for HIV affected patients. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Assessing drivers of implementing "Scaling-up the Systems Analysis and Improvement Approach" for Prevention of Mother-to-Child HIV Transmission in Mozambique (SAIA-SCALE) over implementation waves. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Scaling-up the Systems Analysis and Improvement Approach for prevention of mother-to-child HIV transmission in Mozambique (SAIA-SCALE): a stepped-wedge cluster randomized trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Systems Analysis and Improvement Approach to Optimize Prevention of Mother-To-Child Transmission of HIV Using the Consolidated Framework for Implementation Research. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Systems Analysis and Improvement Approach to optimize the pediatric and adolescent HIV Cascade (SAIA-PEDS): a pilot study. [2023]