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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a strategy to help syringe services programs (SSPs) offer regular, opt-out testing for HIV and Hepatitis C to people who inject drugs. The goal is to improve how these programs link individuals to care if they test positive. The trial compares a group using this new approach, called the ACCESS Intervention, with a group receiving standard resources from the CDC. SSPs suitable for this trial must serve 300 or more people annually and not currently offer this type of testing. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies that could enhance public health services.

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 prior data suggests that the ACCESS Intervention is safe for improving HIV testing in syringe services programs?

Research has shown that the ACCESS program aims to improve HIV testing and connect people who inject drugs to care. Although specific safety data for this program is unavailable, the trial is marked as "Not Applicable" for phase. This designation typically indicates a focus on behavioral or organizational strategies rather than direct medical treatments. Therefore, the usual safety concerns of drug trials do not apply.

In studies on similar approaches, such as increasing access to HIV testing, no major safety issues have emerged. For instance, efforts to boost HIV testing in other locations have successfully increased testing rates without causing problems. This suggests that the ACCESS program is likely safe and concentrates on enhancing service organization rather than introducing new medical procedures or drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACCESS intervention for HIV testing because it aims to enhance the accessibility and engagement of HIV testing services. Unlike traditional methods, which often rely on individuals seeking out testing independently, the ACCESS intervention actively reaches out to participants, potentially increasing testing rates and early diagnosis. This proactive approach could lead to earlier treatment interventions, which are crucial in managing HIV effectively and reducing transmission. By integrating outreach and personalized support, the ACCESS intervention offers a uniquely comprehensive strategy to encourage more widespread and regular HIV testing.

What evidence suggests that the ACCESS Intervention is effective for improving HIV and Hepatitis C testing and care linkage for people who inject drugs?

Studies have shown that syringe service programs can enhance HIV testing and connect people who inject drugs to care. For example, one specific program increased the use of HIV services in similar settings, demonstrating its ability to help more people get tested. Another study found that these programs can boost understanding of HIV and confidence in getting tested. Research also shows that these strategies can increase HIV testing by 21%, with many people completing tests when they receive support. In this trial, participants in the ACCESS Group will receive the ACCESS Intervention, which could effectively improve HIV testing and care for people who inject drugs. ^{1 6 7 8 9}

Who Is on the Research Team?

Tyler Bartholomew, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12329388/

Evaluating the Effectiveness of a Mobile HIV Prevention ... This trial will determine whether the Combine app increases HIV testing, STI testing, and PrEP uptake among rural MSM in the Southern United ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2799111

Effectiveness of an Intervention to Improve HIV Service ... This cluster trial examines the effectiveness of the Bridge HIV care continuum intervention implemented in needle and syringe programs for ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06096519

NCT06096519 | Effectiveness and Implementation of Text ... This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 ...

4. nature.com nature.com/articles/s41598-025-14006-y

A randomized clinical trial testing the effectiveness of an ... Results suggest that this intervention was effective in increasing HIV knowledge and HIV self-efficacy, as well as reducing risky sexual ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9110462/

Interventions to Increase HIV Testing Uptake in Global Settings This strategy improved HIV testing by 21%, with 81% of individual completing an HIV self-test compared with 60% in the referral group [45]. Data ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03713034

An Accessible Digital Intervention to Promote HIV Testing ... The number of participants tested for HIV was measured by tracking data reported by school-based health center staff. The school-based health center staff ...

7. cdc.gov cdc.gov/hivnexus/hcp/diagnosis-testing/index.html

Clinical Testing Guidance for HIV | HIV Nexus CDC recommends all patients between the ages of 13 and 64 get tested for HIV at least once as part of routine health care. Screen patients who may have ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666606521001231

The longer-term effects of access to HIV self-tests on ... We found that higher-risk GBM who had access to free HIVSTs were able to maintain higher HIV testing frequencies after two years compared to men who only had ...

9. who.int who.int/news/item/29-07-2022-who-and-unaids-support-countries-to-introduce-virtual-interventions-and-hiv-self-testing

WHO and UNAIDS support countries to introduce virtual ... During the COVID-19 pandemic, virtual interventions have been used by programmes to sustain service delivery for HIV testing, pre-exposure ...