Reentry Program for HIV/AIDS

(THRASHER 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

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

Is the treatment in the Reentry Program for HIV/AIDS generally safe for humans?

The safety of antiretroviral treatments has been studied, showing that while adverse reactions can occur, they are often not severe. For example, in one study, HIV-negative individuals experienced more frequent adverse events compared to HIV-positive patients, but severe reactions were rare. ^{1 2 3 4 5}

How does the treatment THRASHER differ from other treatments for HIV/AIDS?

The treatment THRASHER is unique because it focuses on supporting individuals with HIV/AIDS during their reentry into the community after incarceration, addressing stress and substance use issues that are common in this population. Unlike standard HIV treatments that primarily focus on antiretroviral therapy, THRASHER may incorporate elements like stress management and life coaching to improve overall health outcomes and reduce the risk of substance use relapse. ^{6 7 8 9 10}

What is the purpose of this trial?

This study will test a behavioral intervention with a case manager/peer navigator team pairing with clients to deliver transition planning services. The interactions help clients recognize and use their strengths. The goal is to see if this approach improves clients' ability to access healthcare and drug treatment after being released from jail.

Research Team

Anne Spaulding, MD, MPH

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. [2022]

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

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. [2019]

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

HAART tolerability: post-exposure prophylaxis in healthcare workers versus treatment in HIV-infected patients. [2013]

4. France pubmed.ncbi.nlm.nih.gov

[Use of Nadis(®) software to improve adverse drug reaction reporting of antiretroviral drugs: experience in south west of France (midi-pyrénées)]. [2019]

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

Removing One Barrier to Protecting Sex Partners in HIV Remission Studies With a Treatment Interruption. [2021]

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

A randomized trial of yoga for stress and substance use among people living with HIV in reentry. [2020]

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

Pairing HIV-positive prisoners with volunteer life coaches to maintain health-promoting behavior upon release: a mixed-methods needs analysis and pilot study. [2013]

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

Patient, medical and legal perspectives on reentry: the need for a low-barrier, collaborative, patient-centered approach. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Transitional care for formerly incarcerated persons with HIV: protocol for a realist review. [2018]

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

Evaluation of Immunologic and Virologic Function in Reincarcerated Patients Living With HIV or AIDS. [2022]