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Not yet recruiting NCT07053514

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

No phase Interventional Hiv

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SD-ART.
Who it may be relevant to
Registry conditions: Hiv. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Peru
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Reductions in patient HIV and multi-dimensional stigma [Time frame: baseline, month 1, month 3, month 6, month 9, and month 12]
  • Provider stigma toward patients [Time frame: baseline, month 1, month 3, month 6, month 9, and month 12]
  • Everyday Discrimination Scale [Time frame: baseline, month 1, month 3, month 6, month 9, and month 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Peru · 2 centers
  • Centro de Salud Raul Patrucco Puig — Lima
  • Hospital Dos de Mayo — Lima

Identifiers

NCT: NCT07053514 · 2000040491 · R01TW013180

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗