Reentry Program for HIV/AIDS

(SHARE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Uncontrolled mental illness, Intellectual impairment, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help individuals with HIV or at high risk connect with healthcare and drug treatment after leaving jail. It evaluates a support program called SUCCESS-E, where a case manager and peer navigators assist participants both in jail and in the community. The trial seeks participants with a history of substance use disorder who are either living with HIV or at high risk of contracting it. Eligible participants should be currently in jail or recently released. The program includes a treatment component called THRASHER, designed to support these individuals in their transition. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for healthcare access and support.

Will I have to stop taking my current medications?

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

What prior data suggests that this behavioral intervention is safe for participants?

Research has not yet provided specific safety information for the THRASHER treatment in humans. The study is marked as "Not Applicable" in terms of phase, indicating it may be in an early stage or classified differently, resulting in limited safety information for people. However, the trial's existence suggests some previous evidence or reasoning for using this treatment.

For concerns or questions about the treatment's safety, discussing them with the study coordinators or a healthcare provider can be helpful. They can provide more details and assist in making an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Reentry Program for HIV/AIDS because it offers a comprehensive approach to healthcare and support for individuals with substance use disorders (SUD) who are living with or at high risk for HIV. Unlike standard care, which may focus primarily on medical treatment, this program uses strength-based case management, providing personalized support from a case manager and peer navigators both in jail and in the community. This method aims to improve linkage and retention in healthcare and SUD treatment, addressing both medical and social needs to enhance overall outcomes.

What evidence suggests that this behavioral intervention is effective for improving healthcare access for individuals with HIV/AIDS after jail release?

Research has shown that people living with HIV often struggle with substance use issues, which can affect their HIV care. In this trial, participants in the SUCCESS-E arm will receive strength-based case management, involving support from peer guides and focusing on individual strengths, to help connect them to healthcare and treatment for substance use. This method promises to improve health by reducing risky behaviors and helping people adhere to their HIV treatments. Additionally, antiretroviral therapy can prevent HIV infection in those who are currently HIV negative. Overall, combining substance use support with HIV care can enhance the health and well-being of those affected. ^{6 7 8 9 10}

Who Is on the Research Team?

Anne Spaulding, MD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

The THRASHER trial is for individuals with HIV/AIDS who are transitioning out of jail. Participants should be willing to work with a case manager/peer navigator team and engage in transition planning services aimed at improving access to healthcare and drug treatment post-release.

Inclusion Criteria

I am living with HIV or at high risk of contracting it.

I understand the study and agree to participate.

Willing to participate in study activities

Exclusion Criteria

Admission to a prison facility (Federal or state)

I understand the consent form and do not have severe mental health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the SUCCESS-E intervention or enhanced discharge planning services

3 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for linkage to ART and program retention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• THRASHER

Trial Overview This study evaluates the SUCCESS-E behavioral intervention, which pairs clients with support teams to leverage their strengths during reentry into society. It aims to determine if this method enhances healthcare and drug treatment accessibility after incarceration.

How Is the Trial Designed?

Group I: SUCCESS-E Experimental Treatment 1 Intervention

Participants with SUD, living with HIV or at high risk for seroconversion, will be placed in strength-based case management, delivered by a case manager and peer navigators, both in jail and in the community, leading to linkage and retention in healthcare and SUD treatment.

Group II: Key informant interviews (KII) Experimental Treatment 1 Intervention

Jail staff and community members willing to participate in Key Informant Interviews (KIIs)

Group III: Control Group Experimental Treatment 1 Intervention

Participants not placed in the intervention group will have healthcare services inform them of possible medical homes for HIV/PrEP care and a list of referral sites for follow-up SUD care.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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]

In a study comparing the tolerability of zidovudine/lamivudine/indinavir in HIV-negative post-exposure prophylaxis (PEP) subjects and HIV-positive patients, the frequency of adverse events was significantly higher in PEP subjects (70.3%) compared to HIV-infected patients (11.1%).

Treatment interruptions due to adverse events were eight times more common in HIV-negative subjects (56.7%) than in HIV-positive patients (7%), although most adverse events were not severe, with only one severe case in the PEP group versus 12 in the treatment group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HAART tolerability: post-exposure prophylaxis in healthcare workers versus treatment in HIV-infected patients. Quirino, T., Niero, F., Ricci, E., et al.[2013]

The MTN-016 study successfully enrolled 420 pregnant women and 381 infants to collect important safety data on HIV prevention agents during pregnancy, demonstrating the feasibility of a multinational pregnancy exposure registry.

With a high retention rate of 86% for infants completing the 12-month follow-up, the study shows that it is possible to effectively gather perinatal safety data alongside ongoing clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. Mhlanga, FG., Noguchi, L., Balkus, JE., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06810973?term=AREA%5BBasicSearch%5D(AREA%5BInterventionSearch%5D(key%20in)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL))&rank=7

Substance Use and HIV Action for Reentry and Engagement. Those at risk of HIV can also take antiretroviral therapy as a preventive measure to lower the risk of seroconversion. Preliminary data suggest that SUCCESS-E, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12179455/

Supporting integration of substance use interventions in HIV ... People with HIV are more likely than the general population to have a substance use disorder (SUD), which can impact the HIV care continuum.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11410345/

HIV and Substance Use Disorders - PMC Pre-exposure Propylaxis (PrEP) for People Who Use Drugs Who are at Risk for HIV. Despite International AIDS Society (IAS)-USA recommendations ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-17113-5

Promoting HIV care continuum outcomes among people who ... ... substance use treatment intervention and assessed HIV care outcomes. ... Use Disorder among Persons Living with HIV. Curr HIV/AIDS Rep ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0376871621007249

Promising outcomes from a cognitive behavioral therapy ... Those who received TXT-CBT reduced HIV-risk behaviors and increased their self-efficacy related to medication adherence. •. TXT-CBT is a potentially scalable ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4928573/

Concurrent Treatment of Substance Use and PTSD - PMC Similarly, Pacella and colleagues reported no significant reductions in substance use in a sample of HIV patients receiving PE [35]. There has been a recent ...

7. uptodate.com uptodate.com/contents/prevention-of-hiv-transmission-during-breastfeeding-in-resource-limited-settings/abstract/84-86

Medline ® Abstracts for References 84-86 of 'Prevention of HIV ... Evidence quality for outcomes in this trial was generally very low to low.One trial of single dose nevirapine versus six weeks of infant zidovudine found the ...

8. researchgate.net researchgate.net/profile/Claire-Thrasher-4

Claire THRASHER | Medical Scientist | PharmD Published data suggests prostacyclin-naïve patients achieve daily oral treprostinil doses around 6 mg by Week 16, while those on prior parenteral ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1700554

Hematopoietic Stem-Cell Gene Therapy for Cerebral ... BK virus is a human polyomavirus that has been implicated as a common cause of late-onset hemorrhagic cystitis in patients who have undergone ...

10. astctjournal.org astctjournal.org/article/S1083-8791(18)30991-1/pdf

Updated Safety and Efficacy Outcomes from an Ongoing Phase ... Of the 17 patients with evaluable data at Month 24, 15 (88%, 95% CI, 63.6%-98.5%) remain alive and. MFD-free with evidence of disease stabilization. The ...