ARC Intervention for HIV/AIDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Correctional facility, Discharged, Deceased, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve HIV treatment outcomes for Black and African American communities by addressing racial disparities in healthcare. It will test an approach called ARC (Accessibility, Responsiveness, Continuity) to enhance clinic operations and patient support. Clinics will either implement ARC or continue their usual care, and the trial will compare patient outcomes such as viral suppression and retention in care. This trial is suitable for individuals living with HIV who have been receiving care at specific Philadelphia clinics for at least six months. As an unphased trial, it offers a unique opportunity to contribute to innovative healthcare solutions that could benefit the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on improving care through organizational changes rather than altering individual treatment plans.

What prior data suggests that the ARC intervention is safe for improving HIV outcomes?

Research has shown that the ARC program has been successfully used in other areas to improve health outcomes. One study demonstrated that ARC interventions enhanced leadership and teamwork in organizations, suggesting safe application in healthcare settings. Although specific safety data on the ARC intervention for HIV/AIDS is lacking, it remains an organizational strategy, not involving new drugs or medical procedures.

The ARC intervention aims to improve clinic operations and patient interactions. It focuses on changing care delivery rather than introducing new medical risks. Therefore, participants do not face the safety concerns associated with experimental drugs or treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ARC Intervention for HIV/AIDS because it focuses on improving healthcare delivery with a unique approach called Accessibility, Responsiveness, and Continuity (ARC). Unlike the standard care, which primarily involves antiretroviral therapy (ART) to manage the virus, ARC aims to enhance the healthcare experience, ensuring patients have better access to care and continuous support. This approach could lead to improved adherence to existing treatments and overall better health outcomes for individuals living with HIV/AIDS.

What evidence suggests that the ARC intervention is effective for improving HIV outcomes?

Research has shown that the ARC program, which participants in this trial may receive, can significantly improve health outcomes for people living with HIV. One study found that ARC led to better results by enhancing the operations of healthcare organizations. The ARC model focuses on making healthcare more accessible, responsive, and continuous, aiming to address issues like racism and discrimination in healthcare. By improving healthcare operations, ARC increases the number of people who maintain control over their HIV and remain in care, particularly among racial and ethnic minority groups more affected by HIV. These improvements are crucial as they lead to better long-term health and help reduce the spread of HIV in the community. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for HIV/AIDS clinics and their staff, focusing on improving care for racial and ethnic minority populations disproportionately affected by HIV. Clinics must be willing to implement new strategies (ARC) or continue with standard care and track patient outcomes like viral suppression and retention in care.

Inclusion Criteria

PLWH in care in one of 12 clinics in Philadelphia with HIV diagnosis date at least one year prior to the administration of the clinic OSC measures and Philadelphia address at the time of HIV diagnosis and successfully linked to care at any point during the study period, defined as having documentation of 1 or more CD4 or VL test results after the date of diagnosis

Clinic workers including clinic leaders, administrators, frontline staff, and providers across participating clinics

Clinic workers: the entire pool of workers employed in the 2 clinics assigned to the intervention arm will be invited to participate in ARC

Exclusion Criteria

Clinic workers not employed in one of the designated roles

My clinic is assigned to standard care and will complete surveys without receiving additional resources.

PLWH in a correctional facility

Timeline for a Trial Participant

Pre-implementation

Evaluation of baseline organizational social context measures across clinics

Not specified

Implementation

Implementation of ARC strategies to improve organizational behavior and reduce racial disparities in HIV outcomes

36 months

Post-implementation

Measurement of HIV outcomes, including viral suppression and retention in care, in both ARC and SOC arms

12 months

Follow-up

Participants are monitored for safety and effectiveness after the main trial phases

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ARC

Trial Overview The study tests ARC, an intervention aiming to improve organizational behavior within HIV clinics to reduce structural racism/discrimination. Clinics will either use ARC or standard care, comparing the effectiveness on patient outcomes such as viral suppression and retention over a period of up to 48 months.

How Is the Trial Designed?

Group I: Accessibility, Responsiveness, Continuity (ARC) Experimental Treatment 1 Intervention

Group II: Standard of Care (SOC) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

A new methadone maintenance treatment program prioritizes admission for opiate addicts who are HIV-infected or showing significant symptoms of HIV, aiming to protect both patient health and public safety.

The program includes comprehensive assessment and treatment planning, medical care, and counseling, while also maintaining patient confidentiality and addressing misbehavior, highlighting a holistic approach to managing addiction in the context of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methadone maintenance program for AIDS-affected opiate addicts. Sorensen, JL., Batki, SL., Good, P., et al.[2019]

In a study involving 495 clients from residential drug abuse treatment programs, both 6-month and 12-month therapeutic community (TC) programs showed no significant differences in changing HIV risk behaviors compared to shorter programs.

While some clients in the relapse prevention (RP) program reduced drug injection and condom use risk, and female clients in the TC program reduced condom use risk, overall, the type and duration of the treatment programs did not significantly impact HIV risk behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in HIV risk behavior following alternative residential programs of drug abuse treatment and AIDS education. McCusker, J., Stoddard, AM., Hindin, RN., et al.[2019]

A review of expert recommendations highlights effective and scalable interventions for improving adherence to antiretroviral therapy (ART) in resource-limited settings, including peer counseling and SMS reminders, which have shown promising results.

The study emphasizes the need for tailored interventions and improved adherence measurement to maximize the impact of ART adherence strategies, ultimately supporting the goal of ending AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving antiretroviral therapy adherence in resource-limited settings at scale: a discussion of interventions and recommendations. Haberer, JE., Sabin, L., Amico, KR., et al.[2022]

Collaborative partnerships between academic institutions, community organizations, and prison staff have successfully developed and evaluated effective HIV prevention interventions for inmates and their partners.

The studies demonstrate that despite access and institutional barriers, it is feasible to implement HIV prevention programs in prison settings, highlighting the importance of collaboration in overcoming these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative research to prevent HIV among male prison inmates and their female partners. Grinstead, OA., Zack, B., Faigeles, B.[2017]

Despite significant federal investment in HIV prevention and treatment, African Americans continue to be disproportionately affected by HIV, highlighting the need for more effective intervention strategies.

A consultation with 20 HIV/AIDS researchers and care providers identified the need for innovative and widely disseminated interventions, focusing on behavioral, community, and biomedical approaches, as well as improved research methods to better support prevention efforts in African American communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations from a research consultation to address intervention strategies for HIV/AIDS prevention focused on African Americans. Purcell, DW., McCree, DH.[2022]

Antiretroviral therapy (ART) coverage in sub-Saharan Africa has dramatically increased from 2% in 2003 to over 40% in 2008, but patient retention remains a critical issue that needs addressing.

The authors propose 10 key interventions to improve patient retention on ART, including standardized monitoring systems, reliable tracking of patient outcomes, and decentralizing care to make it more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to improve patient retention on antiretroviral therapy in sub-Saharan Africa. Harries, AD., Zachariah, R., Lawn, SD., et al.[2021]

In a study of 1160 patients on antiretroviral treatment for HIV-1, 47% experienced clinical adverse events and 27% had laboratory adverse events linked to their treatment, highlighting a significant prevalence of side effects.

The research found that more complex treatment regimens, such as dual-PI and three-class antiretroviral treatments, were associated with a higher likelihood of adverse events compared to simpler single-PI treatments, indicating the need for careful monitoring of patients on these regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study. Fellay, J., Boubaker, K., Ledergerber, B., et al.[2022]

From 1999 to 2003, a pharmacovigilance system at Toulouse University Hospital collected data on antiretroviral drug-induced adverse reactions (ADRs), reporting a total of 613 ADRs from 428 patients.

The majority of reported ADRs (88.6%) were classified as 'non-serious', but 57% of cases required withdrawal of the suspected drugs, highlighting the importance of monitoring and reporting ADRs for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of antiretroviral drugs-induced adverse effects]. Baudrant, M., Bagheri, H., Cuzin, L., et al.[2018]

Between 1999 and 2003, a study at Toulouse University Hospital reported 613 adverse drug reactions (ADRs) from antiretroviral drugs affecting 428 patients, highlighting the importance of monitoring these effects.

Most reported ADRs (88.6%) were classified as 'non-serious', but 57% of cases required stopping the suspected medication, indicating that while many reactions were mild, a significant portion still necessitated intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Bandrant, M., Bagheri, H., Cuzin, L., et al.[2016]

A study of 2,753 patients showed that starting combination antiretroviral therapy (cART) after 1996 significantly improved CD4(+) T-cell counts and reduced the proportion of patients with detectable HIV viral loads over the first four years of treatment.

The likelihood of needing to switch treatments decreased from 53% for those starting cART between 1996-1999 to just 29% for those starting after 2008, indicating that newer cART regimens are more durable and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent trends in early stage response to combination antiretroviral therapy in Australia. McManus, H., Hoy, JF., Woolley, I., et al.[2021]

Improved scientific understanding and pharmacologic therapies for HIV have enhanced the potential benefits of treatment regimens, emphasizing the importance of patient adherence for therapeutic effectiveness.

Nursing interventions aimed at improving adherence focus on three key areas: the patient, the clinician, and the treatment regimen itself, highlighting a comprehensive approach to support successful HIV management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to highly active antiretroviral therapy. Williams, AB.[2005]

In a study of 2650 patients on antiretroviral therapy in Nigeria, the incidence of adverse drug reactions (ADRs) was found to be 4.6 per 100 person-years, with the majority of ADRs occurring in the first six months of treatment, highlighting the need for close monitoring during this period.

Most ADRs were mild (grade 1), with pain and skin rash being the most common types reported, and patients on tenofovir (TDF) experienced fewer ADRs compared to those on zidovudine (AZT) or stavudine (d4T), suggesting that TDF may be a safer option in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. Eluwa, GI., Badru, T., Agu, KA., et al.[2022]

Following the presentation of the DAD cohort study, there was a significant 11% decrease in the prescription of abacavir (ABC) among 7280 antiretroviral medication-naive patients in Canada, indicating a shift in prescribing practices.

The odds of being prescribed ABC compared to tenofovir (TDF) decreased over time, with an adjusted odds ratio of 0.72 per year, suggesting that new safety data influenced clinicians' choices in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Data Collection on Adverse Events of Anti-HIV Drugs cohort study on abacavir prescription among treatment-naive, HIV-infected patients in Canada. Antoniou, T., Gillis, J., Loutfy, MR., et al.[2016]

A review of eight cohort studies found that combination antiretroviral therapy (cART) generally improves the quality of life for people living with HIV/AIDS, with seven out of eight studies reporting positive changes after treatment.

Most studies followed patients for at least one year, but further long-term research is needed to confirm the lasting effects of cART on quality of life, as previous findings suggested improvements may be temporary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of cohort studies of the quality of life in HIV/AIDS patients after antiretroviral therapy. Jin, Y., Liu, Z., Wang, X., et al.[2022]

Between 1996 and 2010, the introduction of new first-line cART regimens in the Netherlands led to significant improvements in viral load suppression and CD4 cell recovery among HIV patients, indicating enhanced efficacy of treatment.

Although mortality rates remained stable, the incidence of patients needing to switch regimens due to virological failure or toxicity decreased by more than half, suggesting that newer treatments are better tolerated and more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in first-line cART regimens and short-term clinical outcome between 1996 and 2010 in The Netherlands. Smit, M., Smit, C., Geerlings, S., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/ED9MYH3wzUGIVEg9BmkBTQ/project-details/10865072

Project Details We propose to test the implementation of ARC (Accessibility, Responsiveness, Continuity) in a randomized controlled trial to improve organizational behavior ...

2. withpower.com withpower.com/trial/phase-acquired-immunodeficiency-syndrome-4-2023-39823

ARC Intervention for HIV/AIDS This trial is for HIV/AIDS clinics and their staff, focusing on improving care for racial and ethnic minority populations disproportionately affected by HIV.

3. trialstoday.org trialstoday.org/trial/NCT06462807

Improving the Organizational Social Context to Address ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890856713001093

Randomized Trial of the Availability, Responsiveness and ... Hierarchical linear models (HLM) analyses indicated that youth outcomes were significantly better in the programs that completed the 18 month ARC intervention.

5. reporter.nih.gov reporter.nih.gov/project-details/11120853

RePORT RePORTER - National Institutes of Health (NIH) | Using a randomized controlled trial, we will implement ARC (Accessibility, Responsiveness, Continuity) to improve organizational behavior and HIV outcomes for ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK219129/

Confronting AIDS: Summary and Recommendations - NCBI Other clinical consequences of HIV infection include fevers, diarrhea, and swollen lymph nodes. Such cases, if not meeting the criteria for AIDS, are termed ARC ...

7. researchgate.net researchgate.net/publication/7449073_The_ARC_Organizational_and_Community_Intervention_Strategy_for_Implementing_Evidence-Based_Children's_Mental_Health_Treatments

The ARC Organizational and Community Intervention ... This paper reviews the implications of organizational and community intervention research for the implementation of effective mental health ...

8. cdc.gov cdc.gov/hiv-data/nhss/national-hiv-prevention-and-care-outcomes.html

National HIV Prevention and Care Objectives | HIV Data In 2022, over 80% of people with diagnosed HIV were linked to care within one month of diagnosis. Only 76% had received some care, 54% were retained in care, ...

9. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-018-3233-4

Evaluation of the impact of the ARC program on national ... The ARC program improved national nursing regulations in participating countries and increased reported leadership, organizational capacity, and collaboration.