PrEP Navigation + Contingency Management for HIV Prevention in Substance Use Disorders

Overseen By Sean M Murphy, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Friends Research Institute, Inc.

Must be taking: PrEP

Disqualifiers: HIV positive, Under 18, others

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

Compensation: Varies

Number of Visits: 8

Duration: 3 months

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to prevent HIV in transgender women and men who have sex with men and have a substance use disorder. It compares two methods: a specialized program offering personalized support and text reminders to take PrEP (a pill that helps prevent HIV) and a standard educational approach. The trial aims to determine which method more effectively encourages consistent use of PrEP and addresses substance use challenges. Individuals who are HIV-negative, have a substance use disorder, and are at high risk for HIV may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to more effective HIV prevention strategies.

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 healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pre-exposure prophylaxis (PrEP) is a safe and effective way to prevent HIV. It is commonly used, and most people tolerate it well. Serious side effects rarely occur, but some individuals might experience mild issues like nausea or headaches, which usually improve over time.

Studies have found contingency management (CM) to be a safe and effective method for treating substance use disorders (SUDs). It involves using rewards to help individuals adhere to their treatment plans. CM has been used successfully for many years without major safety concerns.

Overall, both PrEP and CM have strong safety records, making them reliable options for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ASK-PrEP approach because it offers a personalized and supportive way to improve PrEP adherence for HIV prevention, especially in people with substance use disorders. Unlike standard care, which involves basic education sessions, ASK-PrEP includes five sessions with personalized PrEP navigation and ongoing text-message support to tackle individual barriers like substance use and behavioral health needs. This method is particularly promising because it dynamically adjusts to participants' progress and needs, potentially increasing adherence and reducing HIV risk more effectively than existing options.

What evidence suggests that this trial's treatments could be effective for HIV prevention in individuals with substance use disorders?

Research has shown that Pre-Exposure Prophylaxis (PrEP) effectively prevents HIV. However, starting and continuing the treatment can be challenging for some individuals. In this trial, the ASK-PrEP Stepped Care program serves as one of the treatment arms, offering personalized support through guidance sessions and text messages. This support helps users identify and overcome obstacles to using PrEP, such as issues with drug use and mental health. Early studies indicate that a support system can greatly improve adherence to PrEP, making it a promising option for those at risk. ^{1 2 3 6 7}

Who Is on the Research Team?

Cathy J Reback, PhD

Principal Investigator

Friends Research Institute, Inc.

Sean M Murphy, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

The ASK-PrEP trial is for HIV-negative trans women and men who have sex with men, over 18 years old, at high risk for HIV, and with a substance use disorder (excluding cannabis only). Participants must have missed multiple PrEP doses or not had PrEP care visits in the past 3 months. They should be willing to consent and comply with study requirements.

Inclusion Criteria

I missed taking my PrEP medication 4 or more times a week in the last month.

I identify as a transgender woman or a man who has sex with men.

Verified HIV negative

Exclusion Criteria

I have been consistently taking PrEP and attended all PrEP care visits in the last 3 months.

Unwilling to provide informed consent

I am HIV positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 PrEP navigation sessions with weekly text-messaging support over 3 months, followed by assessment for intervention response

3 months

5 sessions (in-person), weekly text messages

Follow-up

Participants are monitored for PrEP persistence, substance use, and intervention response at 3-month intervals

12 months

Assessments at 3, 6, 9, and 12 months

Contingency Management

Non-responders receive additional attention to their SUD via contingency management, with re-randomization to either ASK-PrEP+CM or CM alone

3 months

Thrice weekly visits for urine samples

What Are the Treatments Tested in This Trial?

Interventions

• ASK-PrEP Stepped Care
• Contingency Management
• Standard of Care

Trial Overview This trial tests a Stepped Care approach versus Standard of Care in preventing HIV. The Stepped Care includes PrEP navigation sessions and weekly text support. Non-responders after three months receive additional focus on their SUD through contingency management.

How Is the Trial Designed?

Group I: Education and Information Experimental Treatment 1 Intervention

The Standard of Care (SOC) intervention includes a 20-30-minute session of PrEP information and where to access PrEP in Los Angeles. The same session is repeated at the 3-month assessment. Participants randomized to the SOC arm receive 2 educational/informational sessions on PrEP misconceptions, uptake, and adherence. The sessions occur at baseline and the 3-month assessment.

Group II: ASK-PrEP Experimental Treatment 2 Interventions

ASK-PrEP is a 5-session PrEP navigation intervention, with text-messaging support, to advance through the PrEP Care Continuum by identifying the individual needs and barriers to PrEP care, including substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Intervention/treatment: PrEP navigation + text messaging Participants receive 5 PrEP navigation sessions within 3 months plus a weekly culturally specific, scripted text message. Participants that do not respond to the ASK-PrEP intervention at the 3-month assessment are re-randomized (1:1) and stepped up to receive ASK-PrEP plus CM or CM alone.

ASK-PrEP Stepped Care is already approved in United States, European Union for the following indications:

Approved in United States as Truvada for:

• HIV prevention

Approved in United States as Descovy for:

• HIV prevention

Approved in United States as Cabotegravir for:

• HIV prevention

Approved in European Union as Truvada for:

• HIV prevention

Approved in European Union as Descovy for:

• HIV prevention

Approved in European Union as Cabotegravir for:

• HIV prevention

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials

60

Recruited

22,500+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

A study involving 801 hospitalized patients with HIV and substance use found that patient navigation, with or without financial incentives, did not improve HIV viral suppression rates compared to standard treatment after 12 months.

Despite the structured interventions aimed at enhancing care coordination and motivation, there were no significant differences in treatment success rates among the three groups, indicating that these approaches may not be effective in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial. Metsch, LR., Feaster, DJ., Gooden, L., et al.[2022]

The PRISM trial tested motivational interviewing (MI) and contingency management (CM) interventions to improve PrEP engagement among 70 cisgender sexual minority men who use stimulants, highlighting the need for tailored approaches to support this population in HIV prevention.

Despite challenges in recruitment, with only about 1 in 10 eligible participants enrolling, the study demonstrated the feasibility of using telehealth to deliver these interventions, suggesting a potential for broader public health impact in promoting PrEP use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial. Davis-Ewart, L., Grov, C., Verhagen, R., et al.[2023]

A qualitative study involving 33 HIV-uninfected people who inject drugs (PWID) revealed high interest in PrEP for HIV prevention, but significant barriers to its use were identified at individual, interpersonal, clinical, and structural levels.

Barriers included low knowledge about PrEP, stigma, negative healthcare experiences, and logistical issues like homelessness and lack of access to prescriptions, highlighting the need for targeted interventions to improve PrEP delivery and uptake among PWID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on HIV pre-exposure prophylaxis (PrEP) utilization and related intervention needs among people who inject drugs. Biello, KB., Bazzi, AR., Mimiaga, MJ., et al.[2019]

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]

The combined Patient Navigation (PN) and Contingency Management (CM) intervention significantly improved self-efficacy for HIV treatment adherence among 801 hospitalized individuals living with HIV and substance use, leading to better engagement in HIV care at 6 months.

This intervention also resulted in increased rates of viral suppression at both 6 and 12 months, highlighting the importance of enhancing self-efficacy as a key mechanism for improving health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-efficacy as a mediator of patient navigation interventions to engage persons living with HIV and substance use. Traynor, SM., Metsch, LR., Gooden, L., et al.[2022]

Only 20.6% of women who use drugs (WWUD) in the U.S. are aware of HIV pre-exposure prophylaxis (PrEP), indicating a significant gap in knowledge about this preventive measure.

Among those who are aware of PrEP, 60.2% expressed willingness to use it, suggesting that increasing awareness could lead to higher uptake of this important HIV prevention strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suboptimal HIV Pre-exposure Prophylaxis Awareness and Willingness to Use Among Women Who Use Drugs in the United States: A Systematic Review and Meta-analysis. Zhang, C., McMahon, J., Simmons, J., et al.[2020]

In a study of 234 HIV-negative individuals with opioid use disorder, only 25.6% were initially aware of long-acting injectable pre-exposure prophylaxis (LAI-PrEP), but after learning about it, 73.5% expressed willingness to use it, indicating a strong interest in this alternative to daily oral PrEP.

Concerns about long-term side effects were prevalent (76.9%), but factors such as being female, recent healthcare visits, high perceived HIV risk, and previous use of oral PrEP were positively associated with the willingness to use LAI-PrEP, suggesting that targeted education and outreach could enhance uptake in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness about and willingness to use long-acting injectable pre-exposure prophylaxis (LAI-PrEP) among people who use drugs. Shrestha, R., DiDomizio, EE., Kim, RS., et al.[2021]

Nearly half of the participants (47%) who started pre-exposure prophylaxis (PrEP) for HIV prevention discontinued its use, primarily due to systemic issues such as financial problems and logistical barriers related to clinics and pharmacies.

Behavioral factors and concerns about medication side effects also contributed to discontinuation, highlighting the need for addressing both systemic and personal factors to improve PrEP retention and engagement in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. Unger, ZD., Golub, SA., Borges, C., et al.[2023]

The patient-centered decision aid (DA) for PrEP significantly increased interest in PrEP among women in addiction treatment, with interest rising from 25% to 89% for those who chose to use the DA.

Women using the DA were more likely to see a healthcare provider for PrEP compared to those receiving enhanced standard of care, indicating that the DA effectively engaged participants in the HIV prevention process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders. Meyer, J., Price, C., Tracey, D., et al.[2022]

A study involving 400 HIV-negative people who use drugs (PWUD) found that the acceptability of pre-exposure prophylaxis (PrEP) varied widely, with an average acceptability of 56.2% across different program scenarios.

The most preferred PrEP scenario included attributes such as insurance coverage, daily dosing, 95% efficacy, no side effects, treatment at an HIV clinic, and biannual HIV testing, highlighting that cost, efficacy, and side effects are critical factors influencing acceptance among this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Acceptability and Preferences for Implementation of Pre-Exposure Prophylaxis (PrEP) Using Conjoint Analysis: An Application to Primary HIV Prevention Among High Risk Drug Users. Shrestha, R., Karki, P., Altice, FL., et al.[2020]

Citations

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Protocol for a randomized controlled trial with a stepped ... Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, ...

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Study Details | NCT05934877 | ASK-PrEP (Assistance ... ASK-PrEP is a two-arm randomized controlled trial (RCT), with a Stepped Care approach, to determine the optimal (considering effectiveness and cost- ...

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Advancing pre-exposure prophylaxis (PrEP) ... Pre-exposure prophylaxis (PrEP) is a safe, highly effective biomedical HIV prevention tool that is tremendously underutilized among people who ...

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Protocol for a randomized controlled trial with a stepped ... Protocol for a randomized controlled trial with a stepped care approach, utilizing PrEP navigation with and without contingency management, for transgender ...

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PrEP Navigation + Contingency Management for HIV ... ASK-PrEP is a two-arm randomized controlled trial (RCT), with a Stepped Care approach, among HIV-negative trans women and men who have sex with men with a ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0749379721003585

Pre-exposure Prophylaxis Uptake, Adherence, and ... This narrative review examines the latest interventions and programs to improve all 3 stages of PrEP adherence and reviews ongoing studies to promote effective ...

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PrEP Care Continuum Engagement Among Persons Who ... Pre-exposure prophylaxis (PrEP) is a medication that prevents HIV acquisition, yet PrEP uptake has been low among people who inject drugs.