Hiv
Conditions
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.
Interventions
BEHAVIORALSD-ART
SD-ART protocol for PWH with both patients and their HIV clinicians
Sponsors
Yale University
National Institutes of Health (NIH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
PWH in Peru and HIV clinicians prescribing ART.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reductions in patient HIV and multi-dimensional stigma | 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. |
| Provider stigma toward patients | 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). |
| Everyday Discrimination Scale | 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 |
Countries
Peru
Contacts
CONTACTDavid Oliveros, MPH
PRINCIPAL_INVESTIGATORFrederick Altice, M.D., M.A
Yale University
Outcome results
None listed