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

Trial Summary

What is the purpose of this trial?

This study will implement a pilot randomized controlled trial (RCT, N=70) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in HIV-care among substance using HIV+ PWID sub-optimally engaged in HIV care.

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 data supports the effectiveness of the treatment iDOT, Cabenuva, cabotegravir, and rilpivirine for HIV+ individuals with substance use disorder?

Research shows that emotion regulation interventions can help people living with HIV improve their emotional well-being and quality of life, which might support adherence to treatments like iDOT, Cabenuva, cabotegravir, and rilpivirine. Additionally, positive affect interventions have been effective in reducing viral load and substance use among HIV+ individuals, suggesting potential benefits for this treatment approach. ^{1 2 3 4 5}

Is the Emotion Regulation Program for HIV+ Individuals with Substance Use Disorder safe for humans?

The research articles provided do not contain specific safety data for the Emotion Regulation Program or related treatments like iDOT, Cabenuva, cabotegravir and rilpivirine, Project iSTRIVE, or iSTRIVE. They focus on the effectiveness of interventions for substance use and HIV management, but do not address safety concerns. ^{4 5 6 7 8}

What makes the Project iSTRIVE treatment unique for HIV+ individuals with substance use disorder?

Project iSTRIVE is unique because it focuses on improving emotion regulation skills, which can help individuals manage their emotions better and potentially reduce substance use. This approach is different from traditional treatments that may not specifically target emotional regulation as a key component of therapy. ^{2 3 4 5 9}

Eligibility Criteria

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

English speaking

HIV positive

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

Exclusion Criteria

HIV negative

Denying injection drug use in past 6 months

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

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]

References

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

The examination of emotion dysregulation as a moderator of depression and HIV-relevant outcome relations among an HIV+sample. [2014]

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

Anxiety sensitivity and hazardous drinking among persons living with HIV/AIDS: An examination of the role of emotion dysregulation. [2018]

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

Brief transdiagnostic group intervention for people living with HIV and emotional disorders: feasibility and clinical utility. [2023]

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

Finding Sunshine on a Cloudy Day: A Positive Affect Intervention for Co-Occurring Methamphetamine Use and HIV. [2023]

5. Switzerland 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. [2023]

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

Affective correlates of stimulant use and adherence to anti-retroviral therapy among HIV-positive methamphetamine users. [2021]

7. United States 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. [2022]

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

Affect regulation, stimulant use, and viral load among HIV-positive persons on anti-retroviral therapy. [2021]

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

Emotion regulation in substance use disorders: a systematic review and meta-analysis. [2023]