PrEP for HIV Prevention in Opioid Use Disorder

(MOST Trial)

Overseen By Tanya Adler, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Connecticut

Must be taking: Opioid use disorder meds, PrEP

Disqualifiers: Suicidal, Homicidal, Psychotic, Dementia

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to enhance HIV prevention strategies for individuals with opioid use disorder who have recently started using Pre-Exposure Prophylaxis (PrEP). Researchers are testing various support methods, such as focusing on memory, attention, and information processing, to determine which is most effective. The trial seeks participants who have recently begun medication for opioid use disorder, exhibit mild cognitive challenges, and have engaged in risky behaviors like unsafe injection drug use or unprotected sex in the past three months. As a Phase 4 trial, it involves an FDA-approved treatment and aims to understand how it can benefit more patients, offering participants a chance to contribute to valuable research.

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 is the safety track record for these treatments?

Research has shown that the Community-Friendly Health Recovery Program (CHRP) is safe for people who use drugs. In various studies, participants have learned to reduce drug risks and have improved their skills in doing so. This indicates that the program helps lower risky behaviors without causing harm.

For Pre-Exposure Prophylaxis (PrEP), research has found it safe for preventing HIV. People without HIV who take PrEP have not faced major health problems. In a large study with over 5,300 participants, 99.7% remained HIV-negative while using PrEP. Some individuals might experience mild side effects, but these are usually not serious.

Both treatments in the trial have strong evidence of safety from past research, providing participants with confidence in their safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the methods being studied for HIV prevention in individuals with opioid use disorder because they integrate cognitive components with traditional interventions. Unlike current options, which typically focus on medication and behavioral counseling, this approach combines Pre-Exposure Prophylaxis (PrEP) with cognitive elements like memory, attention, and executive functioning support. By enhancing cognitive processing alongside standard care, these methods aim to improve adherence to preventive measures and overall health outcomes, offering a more holistic approach to HIV prevention in this vulnerable population.

What evidence suggests that this trial's treatments could be effective for HIV prevention in opioid use disorder?

Studies have shown that Pre-Exposure Prophylaxis (PrEP) effectively prevents HIV. The DISCOVER trial, which included over 5,300 participants, demonstrated that 99.7% of those taking the PrEP medication DESCOVY remained HIV-negative. This highlights PrEP's effectiveness, especially with regular use. In this trial, participants will receive the Community-Friendly Health Recovery Program (CHRP) to help individuals with opioid use disorder adhere to their PrEP routine and reduce their HIV risk. Research indicates that this program enhances HIV prevention by addressing both drug-related and sexual risk factors. Together, these treatments provide a robust method to lower HIV risk for people using opioids. ^{2 6 7 8 9}

Who Is on the Research Team?

Michael Copenhaver, PhD

Principal Investigator

University of Connecticut

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Community-Friendly Health Recovery Program
• Post-Exposure Prophylaxis
• Pre-Exposure Prophylaxis

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

In a study involving individuals receiving medication for opioid use disorder (MOUD), less than one-third were aware of HIV preexposure prophylaxis (PrEP), highlighting a significant knowledge gap.

Very few participants initiated PrEP despite being screened for eligibility, indicating a need for better interventions to promote PrEP engagement among those in MOUD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV Preexposure Prophylaxis Care Continuum Among Individuals Receiving Medication for Opioid Use Disorder, South Carolina, 2020-2021. Johnson, J., Gormley, MA., Bentley, S., et al.[2022]

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]

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 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]

In a study of 132 pregnant individuals with opioid use disorder (OUD), 76.5% were found eligible for preexposure prophylaxis (PrEP) based on modified ACOG criteria, highlighting a significant need for PrEP among this population.

Comorbid psychiatric illness was identified as a significant risk factor for PrEP eligibility, suggesting that mental health support may be crucial in managing pregnant individuals with OUD and assessing their risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Preexposure Prophylaxis Eligibility among Pregnant People with Opioid Use Disorder. Young, AMP., Reddy, P., Gonzalez, AM., et al.[2023]

Pre-exposure prophylaxis (PrEP), particularly using Truvada® (tenofovir disoproxil fumarate/emtricitabine), has been shown to effectively reduce the incidence of HIV infection among high-risk individuals, especially when combined with other preventive methods.

While PrEP has a good safety profile, with mild to moderate gastrointestinal side effects being the most common, regular monitoring of liver enzymes, renal function, and bone mineral density is essential to manage potential long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. Tetteh, RA., Yankey, BA., Nartey, ET., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12205702/

An Evaluation a PrEP-Focused HIV Prevention Intervention ... This study aimed to test the efficacy of the 4-week Bio-behavioral Community-Friendly Health Recovery Program (CHRP-BB) at improving HIV prevention outcomes.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714419300515

Rationale and design of an integrated bio-behavioral ... We developed a brief, bio-behavioral intervention to simultaneously promote PrEP adherence and reduce HIV risk among opioid-dependent PWUD.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03282890

Testing an Integrated Bio-Behavioral Primary HIV ... This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an ...

4. crimesolutions.ojp.gov crimesolutions.ojp.gov/ratedprograms/community-friendly-health-recovery-program-chrp

Community-Friendly Health Recovery Program (CHRP) The CHRP uses a manual-guided approach, which comprises four, 50–minute group sessions that focus on sex- and drug-related HIV risks among ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6051885/

Integrated bio-behavioral approach to improve adherence to ... This study reports the feasibility, acceptability, and preliminary efficacy of the Bio-Behavioral Community-friendly Health Recovery Program (CHRP-BB) - an ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23835735/

A randomized controlled trial of the community-friendly health ... In a randomized controlled trial reported here, we tested the efficacy of the CHRP intervention among high-risk drug users newly enrolled in drug treatment at ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3878981/

A Randomized Controlled Trial of the Community-Friendly ... The CHRP intervention produced improvements in drug risk reduction knowledge as well as demonstrated sex- and drug-risk reduction skills.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0312165

Comparing the brief Holistic Health for HIV (3H+) to the ... In this study, we compared 3H+ to the gold standard, Holistic Health Recovery Program (HHRP+) using a non-inferiority trial.

9. journals.sagepub.com journals.sagepub.com/doi/10.1177/10775587211051182

Coordinating Systems of Care for HIV and Opioid Use ... Pre-/post-test follow-up study to assess efficacy of the Bio-Behavioral Community-friendly Health Recovery Program (CHRP-BB) intervention, a ...