Legal Aid and Training for HIV Care

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Central Florida

Disqualifiers: Incarceration sentence, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to improve HIV care for people who have been in prison by combining legal help with medical care. The program trains healthcare and legal staff to work together and provides integrated services to remove barriers to treatment.

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 focuses on legal aid and training for HIV care, so it's best to ask the trial organizers for more details.

What data supports the effectiveness of the treatment Critical Time Legal Interventions for HIV care?

The systematic review on the organization of care for persons with HIV-infection found that case management and outreach interventions, which are components of Critical Time Legal Interventions, were associated with improved medical and economic outcomes, such as better antiretroviral prescribing and healthcare utilization. ^{1 2 3 4 5}

How does the Legal Aid and Training for HIV Care treatment differ from other treatments for HIV?

This treatment is unique because it focuses on providing legal aid and training to empower people living with HIV, helping them manage stigma and discrimination, rather than directly addressing the medical aspects of HIV. It aims to create a supportive legal environment, which is an innovative approach compared to traditional medical treatments. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

This trial is for individuals who were previously incarcerated and are living with HIV/AIDS. It aims to explore how legal aid can improve their health outcomes. Participants should be interested in receiving legal assistance and willing to engage with healthcare providers trained in medical-legal partnerships.

Inclusion Criteria

I am 18 years old or older.

Living with HIV (as confirmed by medical record)

HIV viral load of more than 200 copies/mL (as confirmed by medical record)

Exclusion Criteria

Individuals who self-report having been sentenced to serve under state or federal custody, with a sentence to begin within 6 months from proposed enrollment in the study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Protocol Finalization

Engagement with advisory boards and finalization of protocols and training manual for the CTI-MLP approach

1 year

Implementation and Pilot Testing

Implementation of training and pilot testing of the CTI-MLP initiative with formerly incarcerated individuals living with HIV

6 months

Follow-up

Participants are monitored for HIV care continuum outcomes and quality of life improvements

1 year

Treatment Details

Interventions

• Critical Time Legal Interventions (Behavioural Intervention)

Trial Overview The study tests the effect of providing legal aid on HIV care for those formerly incarcerated, alongside a training program for healthcare providers. The goal is to see if these interventions help patients stay on track with their HIV treatment and improve communication among caregivers.

Participant Groups

Group I: CTI-MLP assessment Experimental Treatment 1 Intervention

To assess the feasibility and acceptability of a comprehensive critical-time intervention medical legal partnership (CTI-MLP) approach to improve HIV care continuum outcomes among formerly incarcerated individuals and determine the most efficient mechanisms for CTI-MLP delivery

Group II: CTI-MLP approach Experimental Treatment 1 Intervention

To finalize protocols and a medical-legal partnership training manual for health and social service providers at Hope and Help Inc.

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

Dr. Michael Pape

University of Central Florida

Chief Executive Officer since 2015

PhD in Biochemistry from Purdue University, MBA from the University of Chicago Booth School of Business

Dr. James J. Hickman

University of Central Florida

Chief Medical Officer since 2020

MD from University of Central Florida College of Medicine

Hope and Help Center of Central Florida Incorporated

Collaborator

Trials

1

Recruited

100+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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 review of 32 articles highlighted that the knowledge of clinic staff about HIV significantly influences patient satisfaction, emphasizing the importance of well-informed healthcare providers.

While three instruments for measuring patient satisfaction in HIV care were identified, no gold standard exists, indicating a need for a valid and user-friendly tool to enhance service quality based on patient feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-derived outcome measures for HIV services in the developed world: a systematic review. Land, L., Nixon, S., Ross, JD.[2019]

A study of 6,847 HIV-infected individuals showed that early mortality rates significantly decreased from 8.8 deaths per 100 person-years in 2006 to 2.5 in 2016, largely due to improved patient care and earlier ART initiation at higher CD4 counts.

Improved patient care practices accounted for 46% of the reduction in early mortality, highlighting the importance of not only starting ART earlier but also enhancing the overall quality of care for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal trends of early mortality and its risk factors in HIV-infected adults initiating antiretroviral therapy in Uganda. Ssempijja, V., Namulema, E., Ankunda, R., et al.[2022]

A comprehensive intervention has been created to enhance HIV medication adherence specifically targeting individuals who are at high risk of missing doses or medical appointments.

This initiative aims to address the challenges faced by these individuals, potentially leading to better health outcomes and improved management of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study looks at care model to improve drug adherence. Retention care counselor is major feature. [2007]

The Treatment Advocacy Program Intervention was designed to improve medication adherence and sexual safety skills among African American communities affected by HIV/AIDS, addressing the specific needs of a low socio-economic status, urban patient population.

The intervention included tailored, peer-based education sessions that focused on practical skills, highlighting the importance of culturally appropriate approaches in effectively engaging patients in their HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Treatment Advocacy Program--Sinai: a peer-based HIV prevention intervention for working with African American HIV-infected persons. Raja, S., McKirnan, D., Glick, N.[2022]

Interviews with 21 HIV-positive men who have sex with men in Manila revealed that legal protections for people living with HIV are seen as empowering, helping them combat internalized stigma and discrimination.

Despite feeling that these laws signal government support, participants expressed skepticism about the effectiveness of the legal process in protecting their rights, indicating a need for improvements in advocacy and legal support for PLHIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sword and Shield: Perceptions of law in empowering and protecting HIV-positive men who have sex with men in Manila, Philippines. Adia, AC., Restar, AJ., Lee, CJ., et al.[2022]

The UNDP project successfully advanced legal changes to support the rights of key populations affected by HIV in sub-Saharan Africa, highlighting the importance of government-led assessments and capacity building for those impacted.

Engaging in multi-stakeholder dialogues and focusing on broader legal frameworks beyond just 'HIV laws' can lead to significant improvements in knowledge and attitudes, ultimately contributing to more effective legal reforms that positively influence HIV-related outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing changes in HIV-related legal and policy environments: Lessons learned from a multi-country evaluation. Ferguson, L., Nicholson, A., Henry, I., et al.[2018]

Approximately 40% of people living with HIV (PLHIV) in New South Wales, Australia, accessed legal services from the HIV/AIDS Legal Centre (HALC) in the last five years, highlighting the importance of legal support in the HIV response.

There has been a significant increase in legal services related to immigration law for PLHIV, rising from 36% in 2010 to 53% in 2019, while issues related to discrimination have decreased, indicating changing legal needs within this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV-related Legal Needs, Demographic Change, and Trends in Australia since 1992: A Review of Legal Administrative Data. Carter, DJ., Rahmani, A., Evans, R., et al.[2023]

In England and Wales, the HIV sector has successfully influenced the Crown Prosecution Service to create Legal Guidance for prosecutors regarding HIV transmission cases, aiming to improve fairness in the legal process.

This intervention seeks to mitigate harm to individuals living with HIV by ensuring that prosecutions are handled with greater understanding and sensitivity, although the article assesses the actual benefits of this guidance for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing guidance for HIV prosecutions: an example of harm reduction? Azad, Y.[2016]

International human rights law can be effectively utilized by public health advocates to promote better responses to the HIV/AIDS epidemic, ensuring that these responses align with sound public health principles and best practices.

There is a growing trend in development assistance to incorporate rights-based approaches, emphasizing collaboration between health professionals and communities affected by HIV/AIDS, which enhances the effectiveness of legal and human rights advocacy strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International law, human rights and HIV/AIDS. Patterson, D., London, L.[2014]

References

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

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

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

Patient-derived outcome measures for HIV services in the developed world: a systematic review. [2019]

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

Temporal trends of early mortality and its risk factors in HIV-infected adults initiating antiretroviral therapy in Uganda. [2022]

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

Study looks at care model to improve drug adherence. Retention care counselor is major feature. [2007]

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

The Treatment Advocacy Program--Sinai: a peer-based HIV prevention intervention for working with African American HIV-infected persons. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Sword and Shield: Perceptions of law in empowering and protecting HIV-positive men who have sex with men in Manila, Philippines. [2022]

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

Assessing changes in HIV-related legal and policy environments: Lessons learned from a multi-country evaluation. [2018]

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

HIV-related Legal Needs, Demographic Change, and Trends in Australia since 1992: A Review of Legal Administrative Data. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Developing guidance for HIV prosecutions: an example of harm reduction? [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

International law, human rights and HIV/AIDS. [2014]