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

NCT ID: NCT07053514

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-07-31
• Study Completion Date: 2028-07-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

People With HIV (PWH)

SD-ART protocol for PWH prescribed by their HIV clinicians

Group Type: EXPERIMENTAL

SD-ART

Intervention Type: BEHAVIORAL

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

Clinicians prescribing ART

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SD-ART

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

Intervention Type: BEHAVIORAL

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

1. 18 years old or older.

2. Be a clinical staff member at Hospital Dos de Mayo or Patrucco Primary Health Center.

3. Provide informed consent.

• PWH receiving HIV care

1. 18 years old or older.

2. Identify as member of a KAP.

3. Receive HIV care at Hospital Dos de Mayo or Patrucco Primary Health.

4. Provide informed consent.

• PWH who dropped out of HIV care

1. 18 years old or older.

2. Identify as a member of a KAP.

3. Previously received HIV care at Hospital Dos de Mayo or Patrucco Primary Health but dropped out of care, as identified through patient registries.

4. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick Altice, M.D., M.A

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Centro de Salud Raul Patrucco Puig

Lima, , Peru

Hospital Dos de Mayo

Lima, , Peru

Countries

Peru

Central Contacts

David Oliveros, MPH

Role: CONTACT

david.oliveros@yale.edu

202-805-8118

Other Identifiers

R01TW013180

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2000040491

Identifier Type: -

Identifier Source: org_study_id