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NCT Number: NCT07053514

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Raul Patrucco Puig, Lima, Peru

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About this study

The proposed study has 3 aims:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 18 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
  • 18 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
  • 18 years old or older.
  • Identify as a member of a KAP.
  • Previously received HIV care at Hospital Dos de Mayo or Patrucco Primary Health but dropped out of care, as identified through patient registries.
  • Provide informed consent.
  • In-depth interviews
  • 1) 18 years old or older.
  • 2) Be the director of Hospital Dos de Mayo or Patrucco primary health center or the HIV director at the Ministry of Health
  • 3) Provide informed consent
  • Aim 3:
  • Clinical Staff Dyadic Surveys
  • 1) 18 years old or older.
  • 2) Be an HIV provider at Hospital Dos de Mayo or Raul Patrucco Primary Health Center.
  • 3) Provide HIV care to one of the 125 PWH
  • 4) Provide informed consent.
  • Patient Dyadic Surveys
  • 1) 18 years old or older.
  • 2) Identify as a member of a KAP.
  • 3) Be newly diagnosed with HIV and eligible for SD-ART based on clinical criteria identified from Aims 1 and 2.
  • 4) Provide informed consent.

Treatment and study plan

SD-ART

Behavioral

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

Primary outcomes

  1. Reductions in patient HIV and multi-dimensional stigma

    Time frame: baseline, month 1, month 3, month 6, month 9, and month 12

    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.

  2. Provider stigma toward patients

    Time frame: baseline, month 1, month 3, month 6, month 9, and month 12

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

  3. Everyday Discrimination Scale

    Time frame: baseline, month 1, month 3, month 6, month 9, and month 12

    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

Study contacts

Contact information is provided by the study sponsor or research team.

David Oliveros, MPH

CONTACT

[email protected]

202-805-8118

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: Peru SD-ART

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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