Decentralized Care Approach for HIV/AIDS

Recruiting at 1 trial location

Overseen By Frederick L Altice, M.D., M.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Not a clinician, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to make HIV care more accessible by bringing services closer to where people live in Peru. The study tests a combination of two methods, NIATx (Network for the Improvement of Addiction Treatment) and ECHO (Extension for Community Healthcare Outcomes), to determine if they help patients adhere to their HIV treatment. Participants will be grouped to test different schedules of these methods to identify the most effective approach. Healthcare workers in primary or secondary centers in Peru, particularly nurses or doctors with special training, are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in HIV care delivery.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this decentralized care approach is safe for HIV/AIDS patients?

Research has shown that both NIATx and ECHO have been used safely in various settings. NIATx, a method that helps treatment centers enhance their operations, has been tested in addiction treatment services. Studies have demonstrated that it improves services without harming participants.

ECHO, a program that connects specialists with primary care doctors via video calls, facilitates knowledge sharing and improves care without requiring patient travel. No major safety issues have been reported with ECHO.

These programs are generally well-received. They focus on improving healthcare delivery rather than using new drugs or invasive procedures, so the risk of serious side effects remains low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decentralized Care Approach for HIV/AIDS because it combines the NIATx and ECHO models to enhance healthcare delivery for those living with HIV/AIDS. Unlike traditional treatment options that often require patients to visit centralized clinics, this approach leverages technology to provide care remotely, making it more accessible and potentially more consistent. This method aims to streamline healthcare processes, improve patient engagement, and ultimately lead to better health outcomes. The combination of NIATx's process improvement techniques with ECHO's telementoring model could revolutionize how care is delivered, especially in underserved areas.

What evidence suggests that the NIATx + ECHO approach is effective for improving retention in HIV care?

This trial will evaluate the effectiveness of the NIATx and ECHO methods in improving healthcare services for HIV/AIDS. Studies have shown that NIATx reduces wait times and keeps patients engaged in their care at treatment centers. Research has found these methods effective in improving outcomes in addiction treatment. Although primarily used for addiction, these strategies can adapt to other healthcare areas, such as HIV care. By using these methods, clinics can better connect with patients and ensure they continue their treatment, which is essential for managing HIV effectively. Participants in this trial will join different groups to assess the impact of these methods over various timeframes. ^{1 3 5 6 7}

Who Is on the Research Team?

Frederick Altice, M.D., M.A.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for healthcare professionals working at primary or secondary health centers involved in the study, specifically nurses and physicians who have completed ECHO training and leaders of primary health centers. They must consent to participate.

Inclusion Criteria

Aim 3: Continuing Professional Development (N=825): Currently employed as a nurse or physician who fulfilled the ECHO training requirements

Aim 3: Survey of PHC and SHC Clinicians (N=330): Currently employed at a PHC or SHC that is participating in the study. Provide consent for participation.

Aim 3: Survey of PHC Leadership (N=165): Currently serving as the leader of a PHC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

Participants receive standard care in the control phase before the implementation of NIATx+ECHO

6-18 months

NIATx+ECHO Implementation

Implementation of NIATx and ECHO-like tele-education to develop and enhance a Hub and Spoke model

18-24 months

Maintenance

Maintenance phase to assess the long-term sustainability of the decentralized care model

6 months

Follow-up

Participants are monitored for retention in care and viral suppression after the main phases

6 months

What Are the Treatments Tested in This Trial?

Interventions

• NIATx + ECHO

Trial Overview The study is testing a strategy called 'decentralization' to improve HIV care retention by using NIATx (a process improvement approach) along with ECHO (a tele-mentoring model). It aims to provide insights into how decentralizing HIV services can be effectively implemented in urban areas.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 1 Intervention

Control (month 7-24 then NIATx+ECHO (month 25-48) then Maintenance (month 49-54)

Group II: Group 2 Experimental Treatment 1 Intervention

Control (month 7-18) then NIATx+ECHO (month 19-42) then Maintenance (month 43-54)

Group III: Group 1 Experimental Treatment 1 Intervention

Control (month 7-12) then NIATx+ECHO (month 13-36) then Maintenance (month 37-54)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

A study of 410 HIV-infected children in Thailand showed that those receiving care at community hospitals had more severe health issues at the start, but both community and tertiary care resulted in similar improvements in health outcomes after ART, with 86% achieving a viral load of less than 400 copies/ml after 48 months.

Baseline factors like low weight-for-age Z-scores and low CD4% were linked to higher mortality rates, suggesting that nutritional support could enhance the effectiveness of community-based HIV treatment for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful clinical outcomes following decentralization of tertiary paediatric HIV care to a community-based paediatric antiretroviral treatment network, Chiangrai, Thailand, 2002 to 2008. Hansudewechakul, R., Naiwatanakul, T., Katana, A., et al.[2021]

A study comparing 240 HIV patients in Malawi found that those receiving care in decentralized rural health centers incurred significantly lower travel-related expenses compared to those in centralized urban care, highlighting the financial burden of travel for patients.

Despite no differences in lost income or other out-of-pocket costs, the findings suggest that decentralizing HIV services can improve access and reduce costs for poorer patients living farther from health facilities, which is crucial for equitable healthcare delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient costs associated with accessing HIV/AIDS care in Malawi. Pinto, AD., van Lettow, M., Rachlis, B., et al.[2021]

In a study of 7,747 HIV patients in Nigeria, those receiving antiretroviral therapy (ART) at primary hospitals showed better immune recovery and higher rates of viral suppression compared to those at decentralized satellite sites, particularly at 12 and 48 weeks.

Despite the challenges, the decentralization of ART services is feasible in resource-limited settings, but it is crucial to enhance the quality of care to ensure optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcomes in a decentralized antiretroviral therapy program: a comparison of two levels of care in north central Nigeria. Okonkwo, P., Sagay, AS., Agaba, PA., et al.[2022]

Case management interventions were most consistently linked to improvements in immunological outcomes for people living with HIV/AIDS, although they did not show clear benefits for other health measures.

Outreach interventions demonstrated significant improvements in mortality rates, access to antiretroviral medications, and overall healthcare utilization, suggesting they are effective strategies for enhancing care for HIV/AIDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organization of care for persons with HIV-infection: a systematic review. Handford, CD., Tynan, AM., Agha, A., et al.[2019]

Partial decentralisation of HIV treatment, where therapy is initiated in hospitals and continued at health centres, likely reduces patient attrition significantly, with a relative risk of 0.46 based on moderate quality evidence from 39,090 patients.

There is uncertainty regarding the effectiveness of full decentralisation (starting and maintaining therapy at health centres) compared to hospital care, but it appears to result in fewer patients lost to care, indicating potential benefits in accessibility without compromising retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decentralising HIV treatment in lower- and middle-income countries. Kredo, T., Ford, N., Adeniyi, FB., et al.[2023]

Integrating buprenorphine/naloxone treatment with HIV care at 10 sites across the U.S. shows promise in improving outcomes for HIV-infected individuals with substance abuse issues, highlighting the potential for expanded treatment options.

The evaluation of this integrated care model utilized a variety of methods, including patient self-reports and provider surveys, demonstrating that ongoing support and comprehensive evaluation can effectively address implementation challenges in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BHIVES collaborative: organization and evaluation of a multisite demonstration of integrated buprenorphine/naloxone and HIV treatment. Weiss, L., Egan, JE., Botsko, M., et al.[2020]

In a study of 295 HIV-infected drug users, those who had participated in drug treatment programs were able to access HIV medical care significantly faster than those who had not, with a hazard ratio of 2.97.

The ARTAS intervention, designed to improve linkage to care, was found to be more effective for drug users with a history of treatment, showing an adjusted hazard ratio of 5.40, indicating that prior treatment enhances the effectiveness of care linkage strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faster entry into HIV care among HIV-infected drug users who had been in drug-use treatment programs. Gardner, LI., Marks, G., Strathdee, SA., et al.[2019]

The hub-and-spoke model for decentralizing antiretroviral therapy (ART) in Swaziland significantly reduced rates of loss to follow-up (LTFU) and overall attrition among patients, with down-referral showing a protective effect (adjusted hazard ratio of 0.38).

Patients who were initiated on ART at primary health care clinics (spokes) also experienced lower rates of LTFU and attrition compared to those maintained at central facilities (hubs), indicating that spoke-initiation is an effective strategy for improving patient retention in ART programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Operational Research: Evaluation of Swaziland's Hub-and-Spoke Model for Decentralizing Access to Antiretroviral Therapy Services. Auld, AF., Kamiru, H., Azih, C., et al.[2022]

The CommLink program in Eswatini, which provided community-based, peer-delivered HIV care, had a total cost of $2 million, with personnel costs being the largest expense, highlighting the financial investment needed for effective HIV care.

The program demonstrated significant costs per client for initiating and retaining on antiretroviral therapy (ART), with costs of $2114 for starting ART within 7 days and $2343 for remaining on ART after 6 months, indicating the importance of timely and sustained engagement in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Community-Based, Mobile HIV-Care, Peer-Delivered Linkage Case Management in Manzini Region, Eswatini. Suraratdecha, C., MacKellar, D., Hlophe, T., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4630212/

Implementation of Network for the Improvement of Addiction ... NIATx is designed to engage SUD treatment centers in process improvement by targeting highly specific outcomes, such as reduced days between first patient ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1896099/

The Network for the Improvement of Addiction Treatment ... Abstract. The Network for the Improvement of Addiction Treatment (NIATx) teaches participating treatment centers to use process improvement strategies.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037687160600408X

The Network for the Improvement of Addiction Treatment ... The Network for the Improvement of Addiction Treatment (NIATx) teaches participating treatment centers to use process improvement strategies.

4. ajph.aphapublications.org ajph.aphapublications.org/doi/full/10.2105/AJPH.2014.302035

Efficacy of a Process Improvement Intervention on Delivery of ... Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of ...

5. niatx.wisc.edu niatx.wisc.edu/wp-content/uploads/sites/1871/2023/02/NIATxWorkbook_2.pdf

The Network for the Improvement of Addiction ... - NIATx This group pilot-tested a core set of performance measures for addiction treatment services, which show that access to and retention in treatment are the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4873719/

Project ECHO (Extension for Community Healthcare ... ECHO is a distance education model that connects specialists with numerous PCPs via simultaneous video link for the purpose of facilitating case-based learning.

7. icpsr.umich.edu icpsr.umich.edu/web/NAHDAP/studies/34406

Network for the Improvement of Addiction Treatment (NIATx ... The data file covers the dates of contact and treatment with the facility, the number of follow-up units of care received, the primary substance ...