HIV/AIDSNCT06462807
Enhancing the Organizational Social Context to Improve Viral Suppression and Retention in HIV Care
A study testing ARC in people with HIV/AIDS, run by University of Pennsylvania at 1 site in United States.
Trial summary
Despite the widespread use of effective antiretroviral therapy (ART), the HIV epidemic continues to impact racial and ethnic minority populations disproportionately. Although Black/African American persons account for 13% of the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- ARC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2025to 1 Dec 2027
- 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:
- PLWH: in care in one of 12 clinics in Philadelphia
- HIV diagnosis date at least one year prior to the administration of the clinic OSC measures
- Philadelphia address at the time of HIV diagnosis
- successfully linked to care at any point during the study period, defined as having documentation of 1 or more CD4 or Viral Load test results after the date of diagnosis
- Clinic workers: clinic leaders, administrators, frontline staff, and providers across participating clinics
Show all 11Show fewer
- Aim 2:
- PLWH: having an established diagnosis of HIV and receiving care at one of the 4 clinics at least 6 months before the pre-implementation period
- Clinic workers: the entire pool of workers employed in the 2 clinics assigned to the intervention arm will be invited to participate in ARC
- Aim 3:
- Clinic staff and PLWH at clinics receiving ARC
Who cannot join
- Aim 1:
- PLWH: Persons in a correctional facility will be excluded from this analysis
- Clinic workers: Participants who are not employed in one of the roles that were designated
- Aim 2:
- PLWH: Patients who get discharged from a clinic because they moved (or for other reasons) or who died will not be eligible to enter the pre-implementation cohort.
- Clinic workers: Clinics assigned to SOC will not receive ARC but will be asked to complete surveys using the same schedule as the clinics assigned to receive ARC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Florence Momplaisir, MD, 215-746-8555, florence.momplaisir@pennmedicine.upenn.edu
About this study
Official title: Enhancing the Organizational Social Context to Improve Viral Suppression and Retention in HIV Care: A Randomized Controlled Trial
Despite the widespread use of effective antiretroviral therapy (ART), the HIV epidemic continues to impact racial and ethnic minority populations disproportionately. Although Black/African American persons account for 13% of the U.S. population, they account for 41% of new HIV diagnoses and experience the lowest rates of retention in HIV care and viral suppression (VS) compared to other racial/ethnic groups. Structural racism and discrimination (SRD) likely contribute to racial disparities in HIV outcomes.
Although the outpatient setting is a vitally important aspect of care provision for people living with HIV (PLWH), there are limited data on the impact of intra-organizational SRD on HIV outcomes. Longitudinal engagement in HIV care is needed for sustained VS and decreased community transmission of HIV. The organizational social context (OSC) includes organizational culture (organizational norms and values that drive quality of care), organizational climate (perception of the culture and how it impacts personal well-being), and workers' attitudes. Using a randomized controlled trial (RCT), we will implement ARC (Accessibility, Responsiveness, Continuity) to improve organizational behavior and reduce racial disparities in HIV outcomes for PLWH. ARC is an evidence-based intervention that uses three strategies (ARC principles, ARC component tools, and ARC mental models) to create OSCs that support the implementation of interventions to improve patient outcomes.
Read more
Clinics will be randomized to ARC (n = 2) or standard of care (SOC; n= 2). Those assigned to ARC will address SRD occurring at the organizational level affecting care, including referral and treatment patterns for PLWH. A pre-implementation period will be followed by ARC and ARC-associated implementation strategies for 36 months and then a 12-month post-implementation period where we will continue to measure HIV outcomes in both arms. We will compare HIV outcomes, namely VS and retention in care, and intermediate outcomes, such as linkage to mental health treatment and staff turn-over in clinics assigned to ARC and SOC.
We will also evaluate whether individual (self-efficacy, perceived discrimination) and organizational factors (OSC and cohesion of OSC measures) mediate the relationship between ARC, intermediate, and HIV outcomes. In preparation to the RCT, we will evaluate baseline OSC measures across 12 HIV clinics in Philadelphia and determine aspects of the OSC associated with VS and retention in care in a multi-level model adjusting for neighborhood SRD, patient-level factors, and clustering of patients nested in clinics and neighborhoods. We will then test the effectiveness of ARC in improving a primary outcome of VS and secondary outcome of retention in care at the end of the implementation period. We will examine the acceptability, sustainability, and cost of implementing ARC in outpatient HIV care. This research will advance understanding of the impact of SRD on HIV treatment outcomes and health services research and the implementation of a disseminable evidence-based practice aimed at reducing SRD.
- Conditions
- HIV/AIDS
- Being tested
- ARC
- 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.
ARCBehavioural
ARC is an evidence-based intervention that uses three strategies (ARC principles, ARC component tools, and ARC mental models) to create organizational social contexts (OSCs) that support the implementation of interventions to improve patient outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Accessibility, Responsiveness, Continuity (ARC) | Experimental | Not described Receives: Behavioral: ARC |
| Standard of Care (SOC) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
HIV-1 RNA <400 copies per milliliter
Measured: 12-month period
Secondary outcomes (1)
Retention in HIV Care
defined as at least 1 medical visit with a provider with prescribing privileges in each 6-month interval of the 12-month measurement period, with a minimum of 60 days between medical visits
Measured: 12-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start5 Sep 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Florence Momplaisir, MD, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462807
- Sponsor's protocol ID
- 2022-38
- Other IDs
- 1R01NR020764
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Organizational Social Context to Improve Viral Suppression and Retention in HIV Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06462807
- Acronym / sponsor ID
- 2022-38
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Jun 2024 (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.
Despite the widespread use of effective antiretroviral therapy (ART), the HIV epidemic continues to impact racial and ethnic minority populations disproportionately. Although Black/African American persons account for 13% of the U.S. population, they account for 41% of new HIV diagnoses and experience the lowest rates of retention in HIV care and viral suppression (VS) compared to other racial/ethnic groups. Structural racism and discrimination (SRD) likely contribute to racial disparities in HIV outcomes.
Although the outpatient setting is a vitally important aspect of care provision for people living with HIV (PLWH), there are limited data on the impact of intra-organizational SRD on HIV outcomes. Longitudinal engagement in HIV care is needed for sustained VS and decreased community transmission of HIV. The organizational social context (OSC) includes organizational culture (organizational norms and values that drive quality of care), organizational climate (perception of the culture and how it impacts personal well-being), and workers' attitudes. Using a randomized controlled trial (RCT), we will implement ARC (Accessibility, Responsiveness, Continuity) to improve organizational behavior and reduce racial disparities in HIV outcomes for PLWH. ARC is an evidence-based intervention that uses three strategies (ARC principles, ARC component tools, and ARC mental models) to create OSCs that support the implementation of interventions to improve patient outcomes.
Clinics will be randomized to ARC (n = 2) or standard of care (SOC; n= 2). Those assigned to ARC will address SRD occurring at the organizational level affecting care, including referral and treatment patterns for PLWH. A pre-implementation period will be followed by ARC and ARC-associated implementation strategies for 36 months and then a 12-month post-implementation period where we will continue to measure HIV outcomes in both arms. We will compare HIV outcomes, namely VS and retention in care, and intermediate outcomes, such as linkage to mental health treatment and staff turn-over in clinics assigned to ARC and SOC.
We will also evaluate whether individual (self-efficacy, perceived discrimination) and organizational factors (OSC and cohesion of OSC measures) mediate the relationship between ARC, intermediate, and HIV outcomes. In preparation to the RCT, we will evaluate baseline OSC measures across 12 HIV clinics in Philadelphia and determine aspects of the OSC associated with VS and retention in care in a multi-level model adjusting for neighborhood SRD, patient-level factors, and clustering of patients nested in clinics and neighborhoods. We will then test the effectiveness of ARC in improving a primary outcome of VS and secondary outcome of retention in care at the end of the implementation period. We will examine the acceptability, sustainability, and cost of implementing ARC in outpatient HIV care. This research will advance understanding of the impact of SRD on HIV treatment outcomes and health services research and the implementation of a disseminable evidence-based practice aimed at reducing SRD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accessibility, Responsiveness, Continuity (ARC) | Experimental | Behavioral: ARC |
| Standard of Care (SOC) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- PLWH: in care in one of 12 clinics in Philadelphia
- Clinic workers: clinic leaders, administrators, frontline staff, and providers across participating clinics
- PLWH: having an established diagnosis of HIV and receiving care at one of the 4 clinics at least 6 months before the pre-implementation period
- Clinic workers: the entire pool of workers employed in the 2 clinics assigned to the intervention arm will be invited to participate in ARC
- Clinic staff and PLWH at clinics receiving ARC
Key exclusion criteria (6 listed)
- PLWH: Persons in a correctional facility will be excluded from this analysis
- Clinic workers: Participants who are not employed in one of the roles that were designated
- PLWH: Patients who get discharged from a clinic because they moved (or for other reasons) or who died will not be eligible to enter the pre-implementation cohort.
- Clinic workers: Clinics assigned to SOC will not receive ARC but will be asked to complete surveys using the same schedule as the clinics assigned to receive ARC.
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 |
|---|---|---|
| ARCARC is an evidence-based intervention that uses three strategies (ARC principles, ARC component tools, and ARC mental models) to create organizational social contexts (OSCs) that support the implementation of interventions to improve patient outcomes. | Behavioural | Accessibility, Responsiveness, Continuity (ARC) |
Primary outcome
Viral Suppression
Time frame: 12-month period
HIV-1 RNA <400 copies per milliliter
1 secondary outcome
Retention in HIV Care
Time frame: 12-month period
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 19 Oct 2026.
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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.
University of Pennsylvania
Philadelphia, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARC in people with HIV/AIDS, run by University of Pennsylvania at 1 site in United States.
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 11 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression (time frame: 12-month period). 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 19 Oct 2026.