HivPeru SD-ARTNCT07053514
Same-Day Antiretroviral Therapy as a Behavioral Design Intervention to Reduce Stigma in Key Affected Populations
A study testing SD-ART in people with Hiv, run by Yale University at 2 sites in Peru.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv
- What is being tested?
- SD-ART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesPeru
- Study dates
- Oct 2027to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Hiv
- Being tested
- SD-ART
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD-ARTBehavioural
SD-ART protocol for PWH with both patients and their HIV clinicians
| Study group | Role | What they receive |
|---|---|---|
| People With HIV (PWH) | Experimental | SD-ART protocol for PWH prescribed by their HIV clinicians Receives: Behavioral: SD-ART |
| Clinicians prescribing ART | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: baseline, month 1, month 3, month 6, month 9, and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study startOct 2027 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- PWH in Peru and HIV clinicians prescribing ART.
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Frederick Altice, M.D., M.A, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053514
- Sponsor's protocol ID
- 2000040491
- Other IDs
- R01TW013180
- Acronym
- Peru SD-ART
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same-Day Antiretroviral Therapy as a Behavioral Design Intervention to Reduce Stigma in Key Affected Populations
- ClinicalTrials.gov ID
- NCT07053514
- Acronym / sponsor ID
- Peru SD-ART / 2000040491
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2027 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PWH in Peru and HIV clinicians prescribing ART.
| Arm | Type | Receives |
|---|---|---|
| People With HIV (PWH) | Experimental | Behavioral: SD-ARTSD-ART protocol for PWH prescribed by their HIV clinicians |
| Clinicians prescribing ART | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 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:
- Aim 3:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SD-ARTSD-ART protocol for PWH with both patients and their HIV clinicians | Behavioural | People With HIV (PWH) |
Primary outcome
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.
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).
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederick Altice, M.D., M.A principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SD-ART in people with Hiv, run by Yale University at 2 sites in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Oliveros, MPH (202-805-8118, david.oliveros@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reductions in patient HIV and multi-dimensional stigma (time frame: baseline, month 1, month 3, month 6, month 9, and month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.