TRAncenDS for HIV

(TRAnscenDS Trial)

Overseen By CORINA T LELUTIU-WEINBERGER, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Non-Ryan White clinics, others

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

Compensation: Varies

Number of Visits: 6

2400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce the stigma faced by people living with HIV, particularly those who struggle to access and adhere to necessary treatments. It focuses on clinics in the South and East U.S., which will engage in workshops and training sessions to change attitudes and policies. The trial seeks patients and staff from Ryan White HIV/AIDS Program clinics who are interested in helping create a more supportive environment for those living with HIV. As an unphased trial, this study offers participants the opportunity to contribute to meaningful change in HIV care and support systems.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this program is safe for reducing stigma in HIV care?

Research shows that programs like TRANcendS, designed to reduce stigma for people living with HIV, are generally safe and well-tolerated. These programs change attitudes and reduce discrimination through workshops and interactive training sessions. Studies have found that similar programs have not reported any major negative effects. By focusing on education and awareness rather than drugs or medical procedures, these programs create a positive impact. This approach makes them low-risk and suitable for participants concerned about safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TRANcendS because it tackles HIV-related stigma by focusing on education and collaboration. Unlike traditional treatments that primarily focus on medical interventions, TRANcendS aims to reduce stigma through a mix of workshops, interactive trainings, and learning circles, both virtual and in-person. This approach is unique because it not only raises awareness but also encourages a shift in practices within clinics, potentially leading to better patient outcomes and more supportive healthcare environments. The creation of a manual for implementing these changes further ensures that the benefits are sustainable and far-reaching.

What evidence suggests that this trial's treatments could be effective in reducing stigma against living with HIV?

Research has shown that programs like TRANcendS, which participants in this trial will experience, can help reduce the stigma around HIV. Reviews of these programs indicate that reducing stigma can improve adherence to HIV treatments, such as antiretroviral therapy (ART). The TRANcendS intervention includes educational workshops and interactive sessions, which have proven effective in changing attitudes and reducing discrimination. One study found that storytelling videos used in these programs led to more positive views of people living with HIV. Overall, these methods show promise in creating a more supportive environment for people with HIV. ^{2 6 7 8 9}

Who Is on the Research Team?

Corina Lelutiu-Weinberger, PhD

Principal Investigator

Columbia University

Felicia A Browne, ScD

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

This trial is for Ryan White HIV/AIDS Program clinics in the South/East US, focusing on reducing structural racism and discrimination against BIPOC living with HIV and healthcare workers. Clinic leaders must show high motivation to participate, as indicated by specific survey scores.

Inclusion Criteria

Clinic leaders and staff will need to fill out two short surveys to see if their clinic is a good fit for the study. If the clinic scores high on most items, it can be considered for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of the TRAnscenDS intervention across clinics, including workshops, interactive trainings, and learning circles to reduce structural racism and discrimination.

24 months

Multiple workshops and training sessions (virtual and in-person)

Follow-up

Participants are monitored for changes in intersectional stigma, depression, anxiety, and other outcomes every 6 months.

24 months

Surveys every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• TRANcendS

Trial Overview The TRAncenDS intervention is being tested across six selected clinics. It involves interactive trainings aimed at raising awareness and reducing structural racism and discrimination at various levels within the clinic environment over an 18-month period.

How Is the Trial Designed?

Group I: Third Cluster Experimental Treatment 1 Intervention

The intervention will be implemented across three steps with a total of 6 clinics (two clinics per step). The earliest roll-out of the intervention will be at the clinics randomized to Cluster 1. The intervention consists of a mix of Workshops, Interactive Trainings and Learning Circles (virtual and in-person). In the first workshop, the investigators will present baseline findings to all clinic members to 1) raise awareness for the need for intervention to reduce stigma, 2) facilitate collaborative processes, 3) catalyze change for practice change, to 4) guide the intervention process. This workshop will be followed by a series of interactive trainings covering relevant topics, and the creation of a manual to guide the implementation and sustainability of stigma reduction efforts.

Group II: Second Cluster Experimental Treatment 1 Intervention

The intervention will be implemented across three steps with a total of 6 clinics (two clinics per step). The earliest roll-out of the intervention will be at the clinics randomized to Cluster 1. The intervention consists of a mix of Workshops, Interactive Trainings and Learning Circles (virtual and in-person). In the first workshop, the investigators will present baseline findings to all clinic members to 1) raise awareness for the need for intervention to reduce stigma, 2) facilitate collaborative processes, 3) catalyze change for practice change, to 4) guide the intervention process. This workshop will be followed by a series of interactive trainings covering relevant topics, and the creation of a manual to guide the implementation and sustainability of stigma reduction efforts.

Group III: First Cluster Experimental Treatment 1 Intervention

The intervention will be implemented across three steps with a total of 6 clinics (two clinics per step). The earliest roll-out of the intervention will be at the clinics randomized to Cluster 1. The intervention consists of a mix of Workshops, Interactive Trainings and Learning Circles (virtual and in-person). In the first workshop, the investigators will present baseline findings to all clinic members to 1) raise awareness for the need for intervention to reduce stigma, 2) facilitate collaborative processes, 3) catalyze change for practice change, to 4) guide the intervention process. This workshop will be followed by a series of interactive trainings covering relevant topics, and the creation of a manual to guide the implementation and sustainability of stigma reduction efforts.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

RTI International

Collaborator

Trials

201

Recruited

942,000+

Published Research Related to This Trial

Only 31% of people in need of antiretroviral therapy in sub-Saharan Africa are currently receiving it, highlighting a significant gap in treatment access that needs to be addressed to combat HIV effectively.

Key strategies to improve HIV treatment outcomes include scaling up testing, timely initiation of therapy, and enhancing patient adherence and retention in care, which are essential for reducing opportunistic infections and improving overall quality of life for those living with HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to optimize HIV treatment outcomes in resource-limited settings. Nakanjako, D., Colebunders, R., Coutinho, AG., et al.[2022]

In a review of 996 adverse events related to CAR T cell therapy from 2017 to 2019, 19.7% were cardiovascular events (CVEs), with arrhythmias being the most common, indicating a significant risk associated with this treatment.

Patients experiencing CVEs had a higher mortality rate of 30.1%, highlighting the need for careful monitoring for cardiovascular issues, especially in those also presenting with neurotoxicity or cytokine release syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Events Associated with Chimeric Antigen Receptor T Cell Therapy: Cross-Sectional FDA Adverse Events Reporting System Analysis. Guha, A., Addison, D., Jain, P., et al.[2021]

In a study of 187 HIV-infected patients over an average of 19.4 months, enfuvirtide treatment led to a significant mean increase of approximately 102 CD4+ cells/mm³, regardless of the patients' initial CD4+ cell counts.

Patients starting enfuvirtide with CD4+ counts below 100 cells/mm³ did not reach the same CD4+ levels as those starting with higher counts, suggesting that initiating treatment at higher CD4+ levels may provide better immunologic benefits, even if complete viral suppression is not achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunologic benefits of enfuvirtide in patients enrolled in a drug assistance program. Saberi, P., Caswell, NH., Gruta, CI., et al.[2018]

In a study of HIV-1 strains from patients in the Luxembourg HIV Cohort, primary resistance to the fusion inhibitor enfuvirtide (T-20) was found to be rare, with no classic resistance mutations identified in either subtype B or non-B isolates.

Although no major resistance mutations were detected, some uncommon mutations were observed in specific residues of the gp41 protein, suggesting that while T-20 resistance is uncommon, further research is needed to understand these variations and their potential impact on treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uncommon mutations at residue positions critical for enfuvirtide (T-20) resistance in enfuvirtide-naive patients infected with subtype B and non-B HIV-1 strains. Roman, F., Gonzalez, D., Lambert, C., et al.[2020]

The combination of dolutegravir (DTG) and lamivudine (3TC) has shown promising efficacy in treating HIV, with 90% of participants in the PADDLE study achieving viral suppression below 50 copies/mL.

In phase III studies (GEMINI-1 and -2) involving 1,433 treatment-naive adults, the DTG + 3TC regimen demonstrated noninferior efficacy compared to a traditional three-drug regimen, with a better safety profile and no emergence of drug resistance mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dolutegravir plus lamivudine dual therapy - a new option for initial antiretroviral therapy. Fida, M., Rizza, SA., Temesgen, Z.[2020]

In a study of 55 antiretroviral-naive patients recently infected with HIV-1, two cases of primary resistance to the fusion inhibitor enfuvirtide (T20) were identified, marking the first evidence of such resistance in this population.

The overall prevalence of transmitted HIV-1 resistance in the cohort was 20%, highlighting the need for ongoing surveillance of drug-resistant HIV-1 variants, including those resistant to T20.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary resistance to enfuvirtide (T20) in recently HIV-1 infected, antiretroviral-naive patients from the ANRS Aquitaine Cohort. Peuchant, O., Capdepont, S., Ragnaud, JM., 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]

A review of 2905 individual case safety reports (ICSRs) for axi-cel, a CAR-T-cell therapy for B-cell lymphomas, revealed that about 80% of reported adverse events were serious, with significant risks of nervous system and immune system disorders.

The data suggests that axi-cel may have a higher incidence of neurotoxic effects compared to other CAR-T therapies, indicating a need for careful monitoring of these side effects in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pharmacovigilance Study on the Safety of Axicabtagene Ciloleucel Based on Spontaneous Reports from the EudraVigilance Database. Rafaniello, C., Liguori, V., Zinzi, A., et al.[2023]

In a study of 6259 patients starting highly active antiretroviral therapy (HAART) from 2000 to 2010, those treated with efavirenz (EFV) had significantly better outcomes, achieving a composite outcome of success (COS) more frequently than those on boosted protease inhibitors (PIs).

Patients on boosted PIs not only had lower rates of virological suppression but also developed AIDS more frequently and had higher mortality rates compared to those on EFV, highlighting the efficacy and safety advantages of EFV in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of efavirenz or atazanavir/ritonavir is associated with better clinical outcomes of HAART compared to other protease inhibitors: routine evidence from the Italian MASTER Cohort. Postorino, MC., Prosperi, M., Quiros-Roldan, E., et al.[2020]

In a study of 3128 patients starting first-line antiretroviral therapy (ART) in France, treatment failure rates were 25% at 12 months and 42% at 24 months, indicating a significant challenge in long-term HIV management.

Patients on the TDF/FTC/EFV regimen experienced higher treatment failure rates at 12 months compared to those on TDF/FTC with DRV/r, suggesting that efavirenz-based regimens may be less effective in the short term, although no significant differences were observed at 24 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of First Antiretroviral Regimens in Clinical Practice Using a Causal Approach. Cuzin, L., Pugliese, P., Allavena, C., et al.[2022]

In a study involving 737 patients across 60 clinical trials, no evidence of replication competent retrovirus (RCR) was found in 1,595 post-treatment blood samples, supporting the safety of gammaretroviral vectors used in gene therapy.

The majority of the trials (93%) focused on cancer immunotherapy, and the results indicate that current manufacturing methods effectively produce RCR-free products, reinforcing the overall safety profile of retroviral gene therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replication competent retrovirus testing (RCR) in the National Gene Vector Biorepository: No evidence of RCR in 1,595 post-treatment peripheral blood samples obtained from 60 clinical trials. Cornetta, K., Yao, J., House, K., et al.[2023]

In a review of 646 adverse event reports for the CAR T-cell therapy tisagenlecleucel from August 2017 to August 2019, the most common adverse event was cytokine release syndrome (CRS), reported in 51.1% of cases, with a serious outcome in over 95% of reports.

Despite the high reporting rate of adverse events (81.0%), most deaths (64%) were due to the progression of the underlying disease rather than the therapy itself, indicating that no new safety concerns were identified post-marketing, and the rates of CRS and neurotoxicity were lower than those observed in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported to the U.S. Food and Drug Administration Adverse Event Reporting System for tisagenlecleucel. Dores, GM., Jason, C., Niu, MT., et al.[2021]

In a study involving 375 manufactured T cell products and 308 patients, there was no evidence of replication-competent retrovirus/lentivirus (RCR/L), indicating a strong safety profile for gene-modified cell therapies in HIV and oncology.

The data suggests that patients would need to be monitored for over 52 years to potentially observe an RCR/L event, and the time for lentivirus-modified T cell products to fall below the threshold for vector integration site analysis is relatively short, ranging from 0.66 to 1.4 months depending on the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retroviral and Lentiviral Safety Analysis of Gene-Modified T Cell Products and Infused HIV and Oncology Patients. Marcucci, KT., Jadlowsky, JK., Hwang, WT., et al.[2019]

The study used a mathematical simulation model based on data from the ATHENA cohort to analyze differences in mortality rates among HIV treatment centers in The Netherlands, revealing that the distribution of CD4 counts at the time of care entry is a key factor influencing survival rates.

By encouraging earlier treatment for HIV-infected individuals, specifically aiming for a CD4 count of at least 400 cells/mm³ at entry, the model predicts a potential 20% reduction in mortality during the first three years of combination anti-retroviral therapy (cART).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late entry to HIV care limits the impact of anti-retroviral therapy in The Netherlands. Smit, C., Hallett, TB., Lange, J., et al.[2021]

In a study of 74 HIV-1-infected children and adolescents treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) for at least 6 months, 37.8% experienced virological failure, particularly those with poor viral suppression at baseline, highlighting the importance of monitoring treatment adherence.

BIC/FTC/TAF demonstrated a high genetic barrier to resistance, with only one case of a mutation observed, suggesting it is a promising treatment option for pediatric patients who may struggle with adherence and virological control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/emtricitabine/tenofovir alafenamide in paediatrics: Real-life experience from a French cohort (2019-2023). Frange, P., Veber, F., Burgard, M., et al.[2023]

Citations

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