ACCESS Intervention for HIV Testing

(ACCESS Trial)

Overseen By Hansel Tookes, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: FOCUS funding, Opt-out testing, others

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

Compensation: Varies

Number of Visits: Unknown

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 ACCESS Intervention treatment for HIV Testing?

Research shows that receiving HIV test results can significantly increase the rate at which people start antiretroviral therapy (ART), especially among those who were previously unaware of their HIV status. This suggests that targeted HIV testing and counseling, like the ACCESS Intervention, can improve access to necessary treatment. ^{1 2 3 4 5}

How is the ACCESS Intervention treatment for HIV testing different from other treatments?

The ACCESS Intervention for HIV testing is unique because it likely involves innovative strategies like HIV self-testing (HIVST), which allows individuals to test themselves for HIV in private settings. This approach can help reach people who face barriers to traditional testing methods, such as stigma or lack of access to healthcare facilities, making it a novel option compared to standard testing services. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to test the effectiveness of the ACCESS strategy: an organizational-level intervention that uses funding and practice facilitation to improve the organizational capacity of syringe services programs (SSPs) to implement routine, opt-out HIV and Hepatitis C (HCV) testing and linkage to care for people who inject drugs (PWID).

Research Team

Tyler Bartholomew, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for people who inject drugs (PWID) and are using syringe services programs (SSPs). It aims to help these individuals get routine testing for HIV and Hepatitis C, as well as support if they test positive. There's no detailed exclusion criteria provided, but typically participants must meet certain health conditions.

Inclusion Criteria

SSPs not currently offering opt-out HIV/HCV testing

SSPs operating in an Ending the HIV Epidemic (EHE) or Centers for Disease Control and Prevention (CDC) determined vulnerable jurisdictions

SSPs serving at least 300 unique participants per year

Exclusion Criteria

SSPs not currently receiving or having received Frontline Communities in the United States (FOCUS) funding

SSPs not having already implemented opt-out HIV/HCV testing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the ACCESS intervention or control intervention for up to 18 months

18 months

Follow-up

Participants are monitored for outcomes such as the number of SSP participants reached and tested for HIV/HCV

12 months

Treatment Details

Interventions

• ACCESS Intervention

Trial Overview The study is examining the ACCESS strategy, which provides funding and guidance to SSPs to offer regular, automatic HIV and HCV testing with easy access to treatment. The effectiveness of this approach will be compared with a control group not receiving the intervention.

Participant Groups

Group I: ACCESS Group Experimental Treatment 1 Intervention

Participants in this group will receive the ACCESS intervention for up to 18 months

Group II: Control Group Active Control 1 Intervention

Participants in this group will receive a link to the CDC Compendium of Evidence-Based Interventions for up to 18 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Impact of HIV testing on uptake of HIV therapy among antiretroviral naive HIV-infected injection drug users. [2007]

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

Entry and retention in medical care among HIV-diagnosed persons: a meta-analysis. [2022]

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

Care continuum entry interventions: seek and test strategies to engage persons most impacted by HIV within the United States. [2019]

4. England pubmed.ncbi.nlm.nih.gov

HIV testing experiences and their implications for patient engagement with HIV care and treatment on the eve of 'test and treat': findings from a multicountry qualitative study. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Testing and linkage to HIV care in China: a cluster-randomised trial. [2020]

6. Ghana pubmed.ncbi.nlm.nih.gov

Willingness to undergo HIV testing in the Kintampo districts of Ghana. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effective strategies to promote HIV self-testing for men who have sex with men: Evidence from a mathematical model. [2023]

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

Increasing HIV testing among hard-to-reach groups: examination of RAPID, a community-based testing service in Queensland, Australia. [2018]

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

Use and Acceptability of HIV Self-Testing Among First-Time Testers at Risk for HIV in Senegal. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Online HIV Self-Testing (HIVST) Dissemination by an Australian Community Peer HIV Organisation: A Scalable Way to Increase Access to Testing, Particularly for Suboptimal Testers. [2021]