Emotion Regulation Program for HIV+ Individuals with Substance Use Disorder

(iSTRIVE Trial)

Overseen By Abigail W Batchelder, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: HIV negative, No drug use

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

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called Project iSTRIVE, designed to help people with HIV who also use drugs improve their health care involvement. The program includes therapy sessions and a mobile app that rewards medication adherence. Eligible participants should be HIV positive, have struggled with managing the virus in the past year, and have used drugs in the past six months.

As an unphased trial, this study offers a unique opportunity to access innovative support tools that could significantly enhance health management.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this program is safe for HIV+ individuals with substance use disorder?

Research has shown that Project iSTRIVE aims to assist people with HIV who also face substance use issues by enhancing their emotional control and communication skills. The program includes therapy sessions and a mobile app to help participants remember their medication.

The trial is labeled "Not Applicable" for phases, indicating a focus on behavior changes rather than testing new drugs. This suggests that Project iSTRIVE is likely safe, as it primarily involves therapy and app usage. Current research has not reported any major side effects.

Overall, based on available information, Project iSTRIVE appears safe. It is designed to help participants better manage their emotions and adhere to their medication schedules. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Project iSTRIVE because it combines face-to-face therapy sessions with a tech-savvy twist using a mobile app. Unlike traditional treatments that may rely solely on therapy or medication adherence reminders, this program incentivizes medication adherence through directly observed therapy (iDOT) and rewards participants with monetary incentives. This innovative approach not only encourages consistent medication use but also integrates technology to support individuals with HIV and substance use disorders, potentially leading to better health outcomes and more sustainable adherence habits.

What evidence suggests that this trial's treatments could be effective for improving engagement in HIV care among individuals with substance use disorder?

Research has shown that programs for managing emotions can improve health for people with HIV, particularly those who use drugs. In this trial, participants may receive Project iSTRIVE, which teaches skills for handling emotions and improving communication, aiding adherence to HIV treatment. Studies have found that those who learn to manage stress and emotions are more likely to take their medication as prescribed. This program includes therapy sessions and a mobile app to support treatment adherence. Early results suggest these programs can benefit those struggling with HIV care. Another arm of this trial involves incentivized Directly Observed Therapy (iDOT), where participants use a mobile app to record daily medication adherence and receive monetary incentives for doing so. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for HIV-positive adults who have used injection drugs in the past 6 months and are not fully managing their HIV (viral load over 200 copies/mL or no test results in the past year). Participants must be able to consent, speak English, and be at least 18 years old. Those who don't inject drugs or are HIV-negative cannot join.

Inclusion Criteria

HIV positive

HIV virally unsuppressed (>200 copies/mL) in past year or no past-year HIV viral load result

Injection drug use behavior endorsed in past 6 months

Exclusion Criteria

HIV negative

Denying injection drug use in past 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either iDOT alone or iDOT with iSTRIVE intervention, including 6 therapy sessions and mobile app-facilitated incentivized directly observed therapy

12 weeks

6 therapy sessions (in-person), daily video check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of HIV viral load and substance use behaviors

12 weeks

Final follow-up visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• iDOT
• Project iSTRIVE

Trial Overview The study tests a new program called Project iSTRIVE with incentivized Directly Observed Therapy (iDOT) to see if it helps people manage their HIV better by improving emotion control and communication skills. It's a small-scale study where participants are randomly chosen to receive this intervention.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

This intervention includes 6 face-to-face therapy sessions with a trained clinician plus an incentivized directly observed therapy (iDOT) intervention facilitated via a mobile application.

Group II: incentivized Directly Observed Therapy (iDOT) Active Control 1 Intervention

Participants in the iDOT condition will be provided a mobile application to facilitate video recording of their daily medication adherence in order to receive small, escalating monetary incentives for HIV medication adherence.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Fenway Community Health

Collaborator

Trials

36

Recruited

5,833,000+

National Institute of Drug Abuse

Collaborator

Trials

11

Recruited

12,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A Phase II randomized controlled trial involving 110 sexual minority men living with HIV showed that a positive affect intervention combined with community-based contingency management significantly reduced HIV viral load over 15 months compared to a control group.

Participants receiving the positive affect intervention not only had lower viral loads but also reported increased positive feelings and reduced stimulant use, highlighting the intervention's potential to improve both mental health and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention to reduce HIV viral load among sexual minority men who use methamphetamine. Carrico, AW., Neilands, TB., Dilworth, SE., et al.[2023]

A five-session transdiagnostic group intervention significantly improved emotional regulation, anxiety, depression, and quality of life in 10 participants living with HIV, with benefits maintained at a three-month follow-up.

70% of participants normalized their maladjustment scores, and all reported high satisfaction with the treatment, indicating that brief emotion regulation interventions could be effective in public health settings for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief transdiagnostic group intervention for people living with HIV and emotional disorders: feasibility and clinical utility. Gonzalez-Baeza, A., Osma, JJ., Rua-Cebrian, G., et al.[2023]

In a study of 121 HIV-infected injection drug users, the use of cocaine and multiple substances was linked to lower adherence to HIV medications, indicating a significant impact of substance use on treatment outcomes.

Substance use coping strategies were found to mediate the relationship between substance use and medication adherence, suggesting that improving coping mechanisms could help enhance adherence to HIV treatment among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance use predictors of poor medication adherence: the role of substance use coping among HIV-infected patients in opioid dependence treatment. Gonzalez, A., Mimiaga, MJ., Israel, J., et al.[2022]

In a study of 115 people living with HIV/AIDS, it was found that higher depressive symptoms combined with greater emotion dysregulation led to more severe HIV symptoms and lower distress tolerance.

The interaction between depressive symptoms and emotion dysregulation also influenced medication adherence, showing that those with high emotion dysregulation had varying rates of nonadherence depending on their level of depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The examination of emotion dysregulation as a moderator of depression and HIV-relevant outcome relations among an HIV+sample. Brandt, CP., Bakhshaie, J., Zvolensky, MJ., et al.[2014]

The ARTEMIS intervention, a 5-session program tailored for sexual minority men living with HIV who use methamphetamine, effectively enhances the outcomes of traditional substance use treatments like contingency management.

Participants receiving ARTEMIS showed significant reductions in stimulant use, increased positive emotions, and sustained decreases in HIV viral load, highlighting its potential for improving health in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding Sunshine on a Cloudy Day: A Positive Affect Intervention for Co-Occurring Methamphetamine Use and HIV. Olem, D., Earle, M., Gómez, W., et al.[2023]

In a study of 122 HIV-positive men who have sex with men or transgender individuals using methamphetamine, HIV-specific traumatic stress was linked to more frequent cocaine/crack use, highlighting a psychological factor that may influence substance use in this population.

Positive affect was found to be associated with a lower likelihood of injection drug use and a higher likelihood of perfect adherence to anti-retroviral therapy (ART), suggesting that emotional well-being can play a crucial role in treatment adherence among stimulant users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affective correlates of stimulant use and adherence to anti-retroviral therapy among HIV-positive methamphetamine users. Carrico, AW., Johnson, MO., Colfax, GN., et al.[2021]

In a study of 858 HIV-positive individuals, those who regularly used stimulants had a significantly higher HIV viral load, indicating that stimulant use can negatively impact HIV management even when on antiretroviral therapy (ART).

Improved affect regulation, which includes reduced depressive symptoms, was linked to lower rates of stimulant use and better adherence to ART, suggesting that mental health support could enhance treatment outcomes for HIV-positive individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affect regulation, stimulant use, and viral load among HIV-positive persons on anti-retroviral therapy. Carrico, AW., Johnson, MO., Moskowitz, JT., et al.[2021]

In a study of 126 persons living with HIV/AIDS, anxiety sensitivity was found to significantly contribute to hazardous drinking behaviors through the mechanism of emotion dysregulation, indicating a potential pathway for intervention.

The results suggest that addressing emotion dysregulation could be an effective clinical target for reducing hazardous drinking among individuals with HIV/AIDS, as it mediates the relationship between anxiety sensitivity and various alcohol-related outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety sensitivity and hazardous drinking among persons living with HIV/AIDS: An examination of the role of emotion dysregulation. Paulus, DJ., Jardin, C., Bakhshaie, J., et al.[2018]

Individuals with substance use disorders (SUDs) show significantly greater difficulties in emotion regulation compared to those without SUDs, with a mean difference of 21.44 on the Difficulties in Emotion Regulation Scale (DERS).

The analysis revealed that those with SUDs tend to rely more on expressive suppression as a strategy for emotion regulation, indicating a maladaptive approach to managing their emotions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion regulation in substance use disorders: a systematic review and meta-analysis. Stellern, J., Xiao, KB., Grennell, E., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-substance-related-disorders-8-2021-50ea1

Emotion Regulation Program for HIV+ Individuals ... The iSTRIVE medical study, being run by Massachusetts General Hospital, is evaluating whether Project iSTRIVE will have tolerable side effects & efficacy ...

2. istriveresearchlab.com istriveresearchlab.com/

iSTRIVE Research Lab – Investigating Syndemic and Trauma ... The mission of the iSTRIVE Research Lab is to conduct high-caliber research to investigate the combined epidemics—known as “syndemics”—of gender-based violence ...

3. fenwayhealth.org fenwayhealth.org/studies/istrive/

iSTRIVE Seeking people living with HIV who have a history of using drugs to participate in the research study, iSTRIVE The goal of the study is to help people.

4. reporter.nih.gov reporter.nih.gov/search/PuMAu9MNOEioYu8P8rYsLQ/project-details/11055013

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5. istriveresearchlab.com istriveresearchlab.com/projects/

Projects View project, LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care.

6. reporter.nih.gov reporter.nih.gov/search/fk57InbNdEKnrLo1TCpGYw/project-details/11055013

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