NCT07053514

Same-Day Antiretroviral Therapy as a Behavioral Design Intervention to Reduce Stigma in Key Affected Populations

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to develop and implement a same-day ART (SD-ART) protocol for key affected populations with HIV in Peru. The development of the protocol will be guided by asynchronous online focus groups with HIV experts to define eligibility criteria and essential components of the protocol, as well as nominal group technique focus groups and in-depth interviews to identify barriers and facilitators to SD-ART implementation. Finally, investigators will pilot the SD-ART protocol with patients and clinicians using a prospective, longitudinal design integrated into routine HIV care.

Detailed description

The proposed study has 3 aims: 1. Conduct asynchronous online focus groups (AOFGs) and flowcharting to map the current ART initiation process and design a streamlined same-day antiretroviral therapy (SD-ART) protocol as a behavioral design. 2. Assess the multi-level barriers and facilitators to refine and implement an SD-ART protocol from the perspectives of patients, clinicians, and administrators, considering the high levels of stigma and suboptimal HIV treatment outcomes. Findings from Aims 1 and 2 will guide Aim 3. 3. Pilot-test the protocol-concordant SD-ART strategy in newly diagnosed People with HIV where investigators will assess and follow multi-level stigma constructs in patients and providers, analyzed through longitudinal dyadic analyses, to provide the evidence for SD-ART as a behavioral design intervention that reduces stigma. The focus of this registration is the trial in aim 3.

Conditions

• Hiv

Interventions

Type	Name	Description
BEHAVIORAL	SD-ART	SD-ART protocol for PWH with both patients and their HIV clinicians

Timeline

• Start date: 2027-07-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

2 sites across 1 country: Peru