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

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

Trial Summary

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 data supports the effectiveness of the treatment NIATx + ECHO for HIV/AIDS?

Research shows that integrating substance abuse treatment with HIV care, like using buprenorphine/naloxone, can improve health outcomes for people with HIV. Additionally, decentralized care approaches have been shown to improve access to HIV services, especially in rural areas, which can lead to better health outcomes. ^{1 2 3 4 5}

How does the decentralized care approach for HIV/AIDS differ from other treatments?

The decentralized care approach for HIV/AIDS is unique because it shifts treatment from centralized hospitals to local clinics or community settings, making it easier for patients in rural or underserved areas to access care. This approach can improve access and retention in treatment programs, although it may also pose challenges in maintaining the quality of care. ^{3 6 7 8 9}

What is the purpose of this trial?

The purpose of this study is to understand the processes by which HIV care is decentralized, an evidence-informed strategy to improve retention in HIV care, in Peru. Decentralization of HIV services has not been evaluated using experimental designs and urban decentralization studies of HIV are uncommon, so this study will lend important insights for future decentralization efforts in Peru and other countries.

Research Team

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

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

References

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

The BHIVES collaborative: organization and evaluation of a multisite demonstration of integrated buprenorphine/naloxone and HIV treatment. [2020]

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

Organization of care for persons with HIV-infection: a systematic review. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Patient costs associated with accessing HIV/AIDS care in Malawi. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Faster entry into HIV care among HIV-infected drug users who had been in drug-use treatment programs. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Community-Based, Mobile HIV-Care, Peer-Delivered Linkage Case Management in Manzini Region, Eswatini. [2023]

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

Implementation and Operational Research: Evaluation of Swaziland's Hub-and-Spoke Model for Decentralizing Access to Antiretroviral Therapy Services. [2022]

7. Switzerland 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Decentralising HIV treatment in lower- and middle-income countries. [2023]

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

Treatment outcomes in a decentralized antiretroviral therapy program: a comparison of two levels of care in north central Nigeria. [2022]