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

Trial Summary

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 data supports the effectiveness of the ARC treatment for HIV/AIDS?

Research on combination antiretroviral therapy (cART), which is similar to ARC, shows that it improves the quality of life for people living with HIV/AIDS. Studies have found that cART helps patients feel better and live healthier lives, although more research is needed to confirm long-term benefits. ^{1 2 3 4 5}

What safety data exists for ARC Intervention for HIV/AIDS?

The safety data for antiretroviral drugs, which may include ARC, shows that most adverse reactions (side effects) are not serious, but over half of the cases required stopping the drug. This suggests that while many side effects are mild, they can still lead to stopping the treatment. ^{6 7 8 9 10}

How does the ARC treatment for HIV/AIDS differ from other treatments?

The ARC treatment for HIV/AIDS is unique because it focuses on providing methadone maintenance to opiate addicts who are affected by AIDS, aiming to protect their health and slow the spread of HIV. This approach is different from standard antiretroviral therapies as it integrates substance abuse treatment with HIV care. ^{11 12 13 14 15}

What is the purpose of this 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 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, 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, 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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Strategies to improve patient retention on antiretroviral therapy in sub-Saharan Africa. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A systematic review of cohort studies of the quality of life in HIV/AIDS patients after antiretroviral therapy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Recent trends in early stage response to combination antiretroviral therapy in Australia. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Changes in first-line cART regimens and short-term clinical outcome between 1996 and 2010 in The Netherlands. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Adherence to highly active antiretroviral therapy. [2005]

6. France pubmed.ncbi.nlm.nih.gov

[Analysis of antiretroviral drugs-induced adverse effects]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. [2022]

8. United States 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. [2016]

9. France pubmed.ncbi.nlm.nih.gov

[Not Available]. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Methadone maintenance program for AIDS-affected opiate addicts. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Changes in HIV risk behavior following alternative residential programs of drug abuse treatment and AIDS education. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Improving antiretroviral therapy adherence in resource-limited settings at scale: a discussion of interventions and recommendations. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Collaborative research to prevent HIV among male prison inmates and their female partners. [2017]

15. United States pubmed.ncbi.nlm.nih.gov

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