PrEP Behavioral Intervention for HIV/AIDS Prevention

(PrEP Trial)

Recruiting at 1 trial location

Overseen By Angela Bazzi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Severe illness, Cognitive impairment, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized controlled trial will test the efficacy of "PrEP for Health," a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200 PWID to receive either (a) the "PrEP for Health" intervention condition involving theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation (n=100), or (b) the standard of care condition involving PrEP information and referrals (n=100). Successful PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) will be evaluated. The degree to which intervention efficacy occurs through specific conceptual mediators and differs according to hypothesized moderators will also be evaluated.

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 focuses on people who have never taken PrEP before, so it might not require changes to other medications.

What data supports the effectiveness of the drug PrEP for HIV/AIDS prevention?

Research shows that PrEP, specifically using emtricitabine and tenofovir disoproxil fumarate (Truvada), is highly effective in preventing HIV infection in high-risk adults. Another study found that tenofovir alafenamide, when combined with emtricitabine, offers similar protection with better safety for kidneys and bones compared to tenofovir disoproxil fumarate. ^{1 2 3 4 5}

Is PrEP safe for humans?

PrEP, which includes medications like Truvada and Descovy, has been shown to be generally safe for humans. Studies indicate that tenofovir alafenamide may have better kidney and bone safety compared to tenofovir disoproxil fumarate. ^{1 2 3 4 6}

How is the PrEP drug different from other HIV prevention drugs?

PrEP (pre-exposure prophylaxis) is unique because it is taken by people who are not yet infected with HIV to prevent infection, using drugs like Truvada, Descovy, or Apretude, which combine emtricitabine and tenofovir. This approach is different from other HIV treatments that are used after infection occurs. ^{1 2 4 7 8}

Research Team

Katie Biello, PhD, MPH

Principal Investigator

Brown University

Angela Bazzi, PhD, MPH

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for people who inject drugs, are at risk for HIV, have never taken PrEP (a medication to prevent HIV), and engage in behaviors like sharing needles or having unprotected sex. Participants must not be on PrEP currently, understand English or Spanish, and plan to stay in Massachusetts for at least a year.

Inclusion Criteria

I have never taken PrEP.

HIV-uninfected (verified by rapid/4th generation test)

One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)

Exclusion Criteria

Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment

Planning to move out of MA within a year

Living in Massachusetts (MA) for <3 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments conducted before randomization

1 week

1 visit (in-person)

Intervention

Participants receive either the 'PrEP for Health' intervention or standard of care

3 months

Multiple visits (in-person, phone, text)

Follow-up

Participants are monitored for PrEP adherence and receive follow-up assessments

12 months

4 visits (in-person)

Treatment Details

Interventions

• PrEP for Health

Trial Overview The study tests 'PrEP for Health,' which includes education about HIV/PrEP, motivational talks, planning help, and patient navigation versus just getting information and referrals. The goal is to see if the program helps participants start and stick with PrEP over time by checking drug levels in their hair.

Participant Groups

Group I: PrEP for health Experimental Treatment 5 Interventions

Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation.

Group II: Standard of care Active Control 2 Interventions

Participants in the standard of care arm will receive PrEP information and referrals.

PrEP for Health is already approved in United States, European Union for the following indications:

Approved in United States as Truvada for:

• Pre-exposure prophylaxis (PrEP) for HIV prevention in adults and adolescents

Approved in United States as Descovy for:

• Pre-exposure prophylaxis (PrEP) for HIV prevention in adults and adolescents, excluding cisgender women

Approved in United States as Apretude for:

• Pre-exposure prophylaxis (PrEP) for HIV prevention in adults and adolescents

Approved in European Union as Truvada for:

• Pre-exposure prophylaxis (PrEP) for HIV prevention in adults

Approved in European Union as Apretude for:

• Pre-exposure prophylaxis (PrEP) for HIV prevention in adults

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Greater Lawrence Family Health Center

Collaborator

Trials

1

Recruited

200+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

AIDS Action Committee of Massachusetts

Collaborator

Trials

2

Recruited

770+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

The Fenway Institute

Collaborator

Trials

15

Recruited

2,900+

Findings from Research

Emtricitabine/tenofovir disoproxil fumarate (Truvada) has been approved as an effective preexposure prophylaxis (PrEP) therapy for adults at high risk of acquiring HIV through sexual contact.

The article reviews data that supports the efficacy of PrEP, highlighting its role in preventing HIV infection in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. Blackwell, CW.[2015]

A case was reported of a 50-year-old man who contracted wild-type HIV-1 despite consistent use of PrEP (emtricitabine and tenofovir disoproxil fumarate) for 8 months, highlighting that infections can occur even with high adherence to the medication.

The patient exhibited an atypical seroconversion pattern, with no detectable HIV RNA in plasma initially, suggesting that healthcare providers should be vigilant for unusual seroconversion signs and conduct regular HIV testing, even in patients on PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acquisition of wild-type HIV-1 infection in a patient on pre-exposure prophylaxis with high intracellular concentrations of tenofovir diphosphate: a case report. Hoornenborg, E., Prins, M., Achterbergh, RCA., et al.[2022]

In a phase 3 study involving 5387 participants, daily emtricitabine and tenofovir alafenamide was found to be non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, with a lower incidence of HIV infections in the tenofovir alafenamide group (0.16 vs 0.34 infections per 100 person-years).

The tenofovir alafenamide regimen demonstrated better safety profiles, showing superior outcomes in bone mineral density and renal biomarkers compared to the tenofovir disoproxil fumarate regimen, with low rates of adverse events leading to discontinuation in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Mayer, KH., Molina, JM., Thompson, MA., et al.[2022]

A case study of a 21-year-old man showed that despite high adherence to PrEP (measured through various methods), he acquired an HIV strain that was resistant to emtricitabine but susceptible to tenofovir disoproxil fumarate, highlighting a potential limitation of PrEP.

This case emphasizes the importance of regular HIV screening for individuals on PrEP, as early detection and linkage to care can help prevent further transmission, even when adherence to the medication is high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acquisition of tenofovir-susceptible, emtricitabine-resistant HIV despite high adherence to daily pre-exposure prophylaxis: a case report. Cohen, SE., Sachdev, D., Lee, SA., et al.[2023]

In a study involving 121 individuals who seroconverted to HIV, those using the combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) had a higher rate of resistance mutations (57%) compared to those using tenofovir alone (5.3%), indicating that FTC may increase the risk of resistance during breakthrough infections.

Resistance mutations were more likely to occur when PrEP was initiated during an undetected acute HIV infection, highlighting the importance of screening for HIV before starting PrEP to minimize the risk of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of drug resistance among persons acquiring HIV within a randomized clinical trial of single- or dual-agent preexposure prophylaxis. Lehman, DA., Baeten, JM., McCoy, CO., et al.[2022]

In a study involving 540 pregnant women, the use of tenofovir disoproxil fumarate and emtricitabine as pre-exposure prophylaxis (PrEP) was found to be non-inferior to deferred PrEP in terms of preterm birth and small for gestational age outcomes, suggesting it is a safe option during pregnancy.

The immediate initiation of PrEP did not increase the risk of adverse pregnancy outcomes such as low birthweight or stillbirth, providing reassurance for its use among pregnant women not living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. Moodley, D., Lombard, C., Govender, V., et al.[2023]

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 study demonstrated that episodic PrEP (Epi-PrEP) is feasible and well-tolerated among 48 men who have sex with men (MSM) during high-risk vacation periods, with 93.7% showing adherence to the medication as indicated by plasma tenofovir levels.

Despite some participants experiencing common adverse events, none were serious, and over 70% expressed interest in transitioning to daily ongoing PrEP, suggesting that Epi-PrEP could serve as a bridge to long-term prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Short-Term PrEP Uptake for Men Who Have Sex With Men With Episodic Periods of Increased HIV Risk. Egan, JE., Ho, K., Stall, R., et al.[2022]

References

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

Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. [2015]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Acquisition of wild-type HIV-1 infection in a patient on pre-exposure prophylaxis with high intracellular concentrations of tenofovir diphosphate: a case report. [2022]

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

Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Acquisition of tenofovir-susceptible, emtricitabine-resistant HIV despite high adherence to daily pre-exposure prophylaxis: a case report. [2023]

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

Risk of drug resistance among persons acquiring HIV within a randomized clinical trial of single- or dual-agent preexposure prophylaxis. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. [2023]

7. 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]

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

Feasibility of Short-Term PrEP Uptake for Men Who Have Sex With Men With Episodic Periods of Increased HIV Risk. [2022]