PrEP for HIV Prevention in Opioid Use Disorder

(MOST Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Michael Copenhaver, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Connecticut

Must be taking: Opioid use disorder meds, PrEP

Disqualifiers: Suicidal, Homicidal, Psychotic, Dementia

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The investigators will conduct an optimization trial among N=256 PWID newly started on medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP) to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize HIV prevention content, leading to improvements in HIV prevention information, motivation, behavioral skills, and behaviors (IMB).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on medication for opioid use disorder, like methadone or buprenorphine, and to have started PrEP recently.

What data supports the effectiveness of the drug PrEP for HIV prevention in individuals with opioid use disorder?

Research shows that PrEP is an effective medication for preventing HIV among people who inject drugs, but its use is low due to limited awareness and barriers like stigma and homelessness. Efforts to increase PrEP uptake in this group are needed, as it can significantly reduce HIV transmission risk. ^{1 2 3 4 5}

Is PrEP safe for humans?

PrEP, which includes medications like Truvada, has been shown to have a good safety profile in clinical trials. Common side effects are mild to moderate stomach issues like nausea and diarrhea, and regular monitoring is recommended to check liver, kidney, and bone health. ^{6 7 8 9 10}

How is the drug PrEP unique for HIV prevention in opioid use disorder?

PrEP (Pre-Exposure Prophylaxis) is unique because it combines a biomedical approach with behavioral strategies to improve adherence and reduce HIV risk among people with opioid use disorder. It involves taking a daily pill, like Truvada, which contains two medications that help prevent HIV infection before exposure. ^{1 6 7 11 12}

Research Team

Michael Copenhaver, PhD

Principal Investigator

University of Connecticut

Eligibility Criteria

This trial is for adults over 18 who inject drugs, are on opioid addiction treatment like methadone or buprenorphine, have started HIV prevention medication (PrEP) recently, and show mild cognitive issues. They must be able to read English and use a cell phone. People with dementia-like scores, psychosis, or suicidal/homicidal tendencies cannot join.

Inclusion Criteria

Reporting unsafe injection drug use practices or unprotected sex within the past 3 months

Being able to read and understand in English

I have proof of a PrEP prescription, confirming my HIV-negative status.

Exclusion Criteria

Actively homicidal

I am unable to give my consent.

Actively psychotic

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of 16 conditions to receive combinations of CHRP intervention components and compensatory components aimed at enhancing HIV prevention content processing.

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adherence to PrEP and assessment of HIV risk behaviors.

9 months

Treatment Details

Interventions

• Community-Friendly Health Recovery Program (Behavioral Intervention)
• Post-Exposure Prophylaxis (Antiretroviral Agent)
• Pre-Exposure Prophylaxis (Antiretroviral Agent)

Trial Overview The study tests four methods aimed at helping people who inject drugs process HIV prevention information better while they're on opioid disorder medications. It looks at how these methods affect their knowledge, motivation, skills related to HIV prevention behaviors.

Participant Groups

Group I: Condition 9 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components and Attention Components

Group II: Condition 8 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Executive Functioning Components

Group III: Condition 7 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Memory Components, and Executive Functioning Components

Group IV: Condition 6 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Information Processing Components, and Executive Functioning Components

Group V: Condition 5 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components

Group VI: Condition 4 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Information Processing Components, and Memory Components

Group VII: Condition 3 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components and Memory Components

Group VIII: Condition 2 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components and Information Processing Components

Group IX: Condition 16 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, Information Processing Components, and Memory Components

Group X: Condition 15 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Group XI: Condition 14 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components, Attention Components, and Information Processing Components

Group XII: Condition 13 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Executive Functioning Components, and Attention Components

Group XIII: Condition 12 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Information Processing Components, Memory Components, and Attention Components

Group XIV: Condition 11 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Memory Components, and Attention Components

Group XV: Condition 10 Experimental Treatment 2 Interventions

Standard CHRP Intervention Components, Information Processing Components, and Attention Components

Group XVI: Condition 1 Active Control 2 Interventions

Standard CHRP Intervention Components

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Lisa Dunkle

University of Connecticut

Chief Medical Officer since 2018

MD from Johns Hopkins University

Erika Smith

University of Connecticut

Chief Executive Officer since 2020

MBA from the University of Connecticut

Findings from Research

A new intervention was developed to train frontline harm reduction workers (FHRWs) in Baltimore to promote awareness and uptake of PrEP among people who use drugs, addressing the high HIV prevalence in this population.

The training involved 39 FHRWs from various community organizations and aimed to enhance their knowledge and self-efficacy in discussing PrEP with clients, potentially improving PrEP access and adherence among people who use drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Capacity-Strengthening Intervention for Frontline Harm Reduction Workers to Support Pre-exposure Prophylaxis Awareness-Building and Promotion Among People Who Use Drugs: Formative Research and Intervention Development. Glick, JL., Zhang, L., Rosen, JG., et al.[2023]

The opioid and polysubstance epidemics are likely to increase new HIV infections among people who inject drugs (PWID), highlighting the urgent need for effective prevention strategies.

Despite the effectiveness of HIV pre-exposure prophylaxis (PrEP) in reducing HIV incidence among PWID, its uptake is hindered by factors such as limited knowledge, stigma, and structural barriers, including the challenges posed by the HIV testing window period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stuck in the window with you: HIV exposure prophylaxis in the highest risk people who inject drugs. Taylor, JL., Walley, AY., Bazzi, AR.[2020]

A study involving 24 patients from drug detoxification centers revealed that while many participants recognized their risk for HIV, there were mixed perceptions about PrEP, with some viewing it negatively as a sign of high risk.

Despite these perceptions, the detoxification process was seen as a chance to promote healthier lifestyles, indicating a potential opportunity to educate patients and staff about PrEP and its benefits for preventing HIV among people who inject drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I've been 95% safe": perspectives on HIV pre-exposure prophylaxis at a drug detoxification center: a qualitative study. Massey, ESG., Bazzi, AR., Sian, CR., et al.[2023]

A study involving 31 women from an Opioid Intervention Court revealed that their interest in PrEP (a preventive treatment for HIV) is influenced by their perceptions of HIV risk and various barriers to accessing the medication.

The research suggests that the criminal justice system could be an effective setting for providing PrEP education and HIV risk assessments, highlighting the need for gender-specific interventions to reduce HIV incidence among women with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I think everybody should take it if they're doing drugs, doing heroin, or having sex for money": a qualitative study exploring perceptions of pre-exposure prophylaxis among female participants in an opioid intervention court program. Przybyla, SM., Cerulli, C., Bleasdale, J., et al.[2021]

The study demonstrated that pre-exposure prophylaxis (PrEP) using Truvada is a highly effective strategy for preventing HIV infection among men who have sex with men, with strong retention and compliance rates observed during the study period from January 2017 to March 2021.

Safety assessments indicated that PrEP was well-tolerated, with no significant adverse events related to Truvada, and regular monitoring of renal function showed no major issues, supporting the safety of this preventive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study. Terada-Hirashima, J., Mizushima, D., Takano, M., et al.[2023]

The use of PrEP (Truvada) among Medicaid recipients in New York state significantly increased from 259 prescriptions in 2012-2013 to 1,330 in 2014-2015, highlighting the effectiveness of statewide efforts to promote awareness and access to this preventive treatment.

The collaboration between state and local health departments, along with Medicaid coverage for PrEP, has been crucial in removing barriers to access, suggesting that similar strategies could be effective in other regions to enhance HIV prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vital Signs: Increased Medicaid Prescriptions for Preexposure Prophylaxis Against HIV infection--New York, 2012-2015. Laufer, FN., O'Connell, DA., Feldman, I., et al.[2018]

Tenofovir/emtricitabine (Truvada) has been shown to be highly effective as preexposure prophylaxis (PrEP) for preventing HIV infection, with studies indicating excellent prevention when taken at least four times a week.

Despite its efficacy, challenges remain in the USA regarding awareness and acceptance of PrEP among at-risk individuals and healthcare providers, which are crucial for scaling up its use effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA. Elion, R., Coleman, M.[2023]

The study aims to evaluate the effectiveness of a new bio-behavioral intervention called the Community-friendly Health Recovery Program (CHRP-BB) in improving PrEP adherence and reducing HIV risk among opioid-dependent people who use drugs (PWUD) enrolled in a methadone maintenance program, using a randomized controlled trial design.

This research will assess participants at multiple time points over 44 weeks, focusing on both biomedical outcomes (like PrEP adherence) and behavioral changes (such as drug and sex-related HIV risk behaviors), making it one of the first trials to integrate these approaches for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of an integrated bio-behavioral approach to improve adherence to pre-exposure prophylaxis and HIV risk reduction among opioid-dependent people who use drugs: The CHRP-BB study. Shrestha, R., Altice, FL., Sibilio, B., et al.[2020]

A study involving 29 staff members from two methadone clinics revealed that while all recognized the need for HIV prevention among people who use drugs, most were either unaware of PrEP or confused it with HIV treatment, highlighting a significant knowledge gap.

About half of the staff expressed support for PrEP, but mixed or negative attitudes were also present, often tied to stigma around HIV and sexual behavior, indicating the need for comprehensive PrEP education for all clinic staff to improve patient discussions and acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis awareness, acceptability and potential stigma among medical and non-medical clinic staff in methadone treatment settings in northern New Jersey: The key role of non-medical staff in enhancing HIV prevention. Jaiswal, J., Dunlap, K., Griffin, M., et al.[2022]

References

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

HIV Preexposure Prophylaxis Care Continuum Among Individuals Receiving Medication for Opioid Use Disorder, South Carolina, 2020-2021. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

A Novel Capacity-Strengthening Intervention for Frontline Harm Reduction Workers to Support Pre-exposure Prophylaxis Awareness-Building and Promotion Among People Who Use Drugs: Formative Research and Intervention Development. [2023]

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

Stuck in the window with you: HIV exposure prophylaxis in the highest risk people who inject drugs. [2020]

4. England pubmed.ncbi.nlm.nih.gov

"I've been 95% safe": perspectives on HIV pre-exposure prophylaxis at a drug detoxification center: a qualitative study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

"I think everybody should take it if they're doing drugs, doing heroin, or having sex for money": a qualitative study exploring perceptions of pre-exposure prophylaxis among female participants in an opioid intervention court program. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study. [2023]

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

Vital Signs: Increased Medicaid Prescriptions for Preexposure Prophylaxis Against HIV infection--New York, 2012-2015. [2018]

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

Predictors of Preexposure Prophylaxis Eligibility among Pregnant People with Opioid Use Disorder. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]

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

The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA. [2023]

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

Rationale and design of an integrated bio-behavioral approach to improve adherence to pre-exposure prophylaxis and HIV risk reduction among opioid-dependent people who use drugs: The CHRP-BB study. [2020]

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

Pre-exposure prophylaxis awareness, acceptability and potential stigma among medical and non-medical clinic staff in methadone treatment settings in northern New Jersey: The key role of non-medical staff in enhancing HIV prevention. [2022]