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

NCT07053514 | Not Yet Recruiting

• 2 other identifiers: 2000040491R01TW013180
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hiv

Outcome Measures

Primary Outcomes (3)

• Reductions in patient HIV and multi-dimensional stigma

  Assessed using a modified 10-item version of the Berger HIV stigma scale, which has been previously translated into Spanish and validated in Peru. Total score range from 40 to 160. Higher scores denote higher levels of HIV stigma.

  baseline, month 1, month 3, month 6, month 9, and month 12

• Provider stigma toward patients

  Measured through feeling thermometers (on a scale from 0-100) of various identity groups (people with HIV, sexual minorities, people who use drugs).

  baseline, month 1, month 3, month 6, month 9, and month 12

• Everyday Discrimination Scale

  This is a 5-item scale that is rated on a 6-point scale (range from 0 to 30), with higher scores denoting higher levels of multi-dimensional stigma and experiences with discrimination

  baseline, month 1, month 3, month 6, month 9, and month 12

Study Arms (2)

People With HIV (PWH)

EXPERIMENTAL

SD-ART protocol for PWH prescribed by their HIV clinicians

Behavioral: SD-ART

Clinicians prescribing ART

NO INTERVENTION

Interventions

SD-ART BEHAVIORAL

SD-ART protocol for PWH with both patients and their HIV clinicians

People With HIV (PWH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1:
• HIV experts will be selected from National Societies of HIV experts according to the following criteria: 1) 18 years old or older; 2) Be an HIV expert, including those from NGOs providing HIV care, and international specialists; 3) Provide informed consent.
• Aim 2:
• NGT Focus Groups (FG)
• Staff members
• years old or older.
• Be a clinical staff member at Hospital Dos de Mayo or Patrucco Primary Health Center.
• Provide informed consent.
• PWH receiving HIV care
• years old or older.
• Identify as member of a KAP.
• Receive HIV care at Hospital Dos de Mayo or Patrucco Primary Health.
• Provide informed consent.
• PWH who dropped out of HIV care
• years old or older.

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Centro de Salud Raul Patrucco Puig

Lima, Peru

Location

Hospital Dos de Mayo

Lima, Peru

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Frederick Altice, M.D., M.A

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Oliveros, MPH

CONTACT

202-805-8118; david.oliveros@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PWH in Peru and HIV clinicians prescribing ART.

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 8, 2025
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PE (2)