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

Trial Summary

What is the purpose of this trial?

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 substance use disorder (SUD). Participants will be randomized (3:1) to the ASK-PrEP Stepped Care arm or Standard of Care (SOC). Participants in the ASK-PrEP Stepped Care arm will receive 5 PrEP navigation sessions, with weekly text-messaging support, delivered over 3 months, at which point they will be assessed for intervention response. Responders will be maintained for an additional 3 months in ASK-PrEP to receive an additional 5 PrEP navigation session with weekly text-messaging support, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone) for an additional 3 months.

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.

What data supports the effectiveness of the treatment PrEP Navigation + Contingency Management for HIV Prevention in Substance Use Disorders?

Research shows that while awareness and uptake of PrEP (a medication to prevent HIV) among people who use drugs is low, there is potential to increase its use by improving awareness and addressing cost concerns. Additionally, PrEP is clinically effective for HIV prevention, and its acceptability is high when cost and side effects are managed. ^{1 2 3 4 5}

Is PrEP safe for humans?

Research indicates that PrEP is generally safe for humans, with the most acceptable scenarios being those with no side effects. Concerns about long-term side effects exist, but PrEP is widely accepted when perceived as having no side effects. ^{1 2 3 4 6}

How is the PrEP Navigation + Contingency Management treatment different from other HIV prevention treatments?

This treatment is unique because it combines patient navigation (helping patients access and stay in care) with contingency management (providing rewards for meeting health goals) to improve engagement in HIV prevention for people with substance use disorders, addressing both healthcare access and behavioral challenges. ^{1 7 8 9 10}

Research Team

Cathy J Reback, PhD

Principal Investigator

Friends Research Institute, Inc.

Sean M Murphy, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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]

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 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]

References

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

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. [2023]

2. United States 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. [2020]

3. 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]

4. United States 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. [2020]

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

Perspectives on HIV pre-exposure prophylaxis (PrEP) utilization and related intervention needs among people who inject drugs. [2019]

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

Awareness about and willingness to use long-acting injectable pre-exposure prophylaxis (LAI-PrEP) among people who use drugs. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Self-efficacy as a mediator of patient navigation interventions to engage persons living with HIV and substance use. [2022]

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

Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders. [2022]

9. United States 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. [2022]

10. Canada 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. [2023]