Apply to Trial

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

40 Participants Needed

SmartSteps Intervention for HIV Prevention
(SmartSteps Trial)

Overseen ByGeorgia Goodman, BS

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Fenway Community Health

Must be taking: PrEP

Disqualifiers: Crohn's, Ulcerative colitis, others

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

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a daily digital pill for HIV prevention among HIV-negative men who have sex with men. Participants will use a smart pill system and a smartphone app to track their medication and gather information about their habits and adherence to the treatment. The study aims to evaluate the effectiveness and user-friendliness of this combination for individuals at risk of HIV who also have a substance use disorder. Those who are HIV-negative, already on PrEP (pre-exposure prophylaxis, such as Descovy or Truvada) or starting it, and own a smartphone are suitable candidates. Participants should also be comfortable with technology and willing to provide feedback. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking HIV prevention method.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on PrEP or starting PrEP to participate.

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

Research shows that the digital pill system (ID-Cap System) is safe, effectively tracking 92% of expected doses. It operates well without causing problems for users. The FDA has cleared the system, confirming it meets safety standards.

Regarding the Beiwe app, studies indicate user acceptance. The app collects data from smartphones to understand behavior and medication habits. It is designed to help, not harm, and no evidence suggests it causes harm.

The treatments in this trial, Descovy and Truvada, are both FDA-approved for preventing HIV, indicating they have been tested for safety and are generally well-tolerated. Some people might experience mild side effects, but serious issues are rare.

Overall, based on previous research and approvals, the components of this trial appear safe.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about the SmartSteps intervention for HIV prevention because it combines existing HIV prevention drugs, Descovy or Truvada, with cutting-edge digital technology. Unlike traditional methods where adherence is tracked manually, this approach uses the ID-Cap digital pill system and the Beiwe digital phenotyping app to monitor medication intake in real-time. This innovative delivery method allows for precise tracking of daily pill consumption, offering potential improvements in adherence and personalized feedback, which could significantly enhance the effectiveness of HIV prevention strategies.

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

Research has shown that taking Descovy or Truvada as PrEP (pre-exposure prophylaxis) can almost completely prevent HIV if taken regularly. In this trial, participants will use the ID-Cap System, which tracks pill intake and is well-liked for aiding adherence to medication schedules. A tiny sensor confirms when a pill is swallowed, simplifying medication tracking. Additionally, participants will use the Beiwe app, which collects data on smartphone use to understand habits affecting medication adherence. Together, these tools aim to improve adherence to PrEP plans, enhancing the treatment's effectiveness in preventing HIV.¹ ³ ⁴ ⁶ ⁷

Who Is on the Research Team?

Peter R Chai, MD MMS

Principal Investigator

Brigham and Women's Hopsital

Are You a Good Fit for This Trial?

This trial is for HIV-negative cisgender men who have sex with men and struggle with substance use, scoring moderate to high on a substance use screener. They must be 18 or older, own a smartphone, and either be on PrEP (HIV prevention medication) or starting it. Excluded are those with certain gastrointestinal conditions, allergies to digital pill components or PrEP, unwillingness to use the study's digital tools, non-English speakers, or those with specific medical histories.

Inclusion Criteria

HIV negative

Qualifying laboratory testing for PrEP: Cr clearance in past 3 months, HBV vaccination, liver function tests

I am a cisgender male.

See 4 more

Exclusion Criteria

You are allergic to gelatin, silver, or zinc, which are used to make the digital pill.

You are allergic to the medication used for pre-exposure prophylaxis (PrEP).

I am not willing to use the DPS or Beiwe app.

See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Enrollment

Participants complete baseline assessments, receive training on the digital pill system and Beiwe app, and ingest their first digital pill dose under observation

1 visit

1 visit (in-person)

Treatment

Participants take one PrEP digital pill per day for 60 days, using the digital pill system and Beiwe app. Nonadherence is monitored with surveys and timeline followback discussions

8 weeks

2 visits (in-person)

Follow-up

Participants undergo qualitative exit interviews and dried blood spot testing to assess PrEP adherence and user experience

1 visit

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

Beiwe
Descovy or Truvada
ID-Cap System

Trial Overview The SmartSteps study observes how well individuals adhere to their daily PrEP regimen using a digital pill system and an app called Beiwe over two months. It aims to understand adherence patterns by sending surveys on days when doses are missed and collecting data about substance use and sexual activity.

How Is the Trial Designed?

1Treatment groups

Experimental Treatment

Group I: Digital Pills and BeiweExperimental Treatment3 Interventions

Participants will take one PrEP digital pill per day, for 60 days total, while using the ID-Cap digital pill system and Beiwe digital phenotyping app.

Descovy or Truvada is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Descovy for:

Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg

Approved in United States as Truvada for:

Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg
Treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg

Approved in European Union as Descovy for:

Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg

Approved in European Union as Truvada for:

Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg
Treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg

Approved in Canada as Descovy for:

Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg

Approved in Canada as Truvada for:

Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg
Treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fenway Community Health

Lead Sponsor

Trials

Recruited

5,833,000+

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

The Fenway Institute

Collaborator

Trials

Recruited

2,900+

Published Research Related to This Trial

Daily oral PrEP with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for men who have sex with men, but its effectiveness in cisgender women has been inconsistent, highlighting the need for diverse HIV prevention options.

Newer strategies like injectable long-acting cabotegravir have shown superior effectiveness compared to daily oral TDF/FTC, and ongoing studies are exploring other formulations like islatravir and lenacapavir, which may offer more flexible and effective prevention methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities for Preexposure Prophylaxis.Cambou, MC., Landovitz, RJ.[2021]

In the FEM-PrEP trial involving seroconverting women, there was no significant difference in HIV-1 RNA levels or CD4+ T-cell counts between those on PrEP and those on placebo, indicating that PrEP did not lead to better outcomes in these measures.

While no tenofovir resistance was found, FTC resistance was detected in some participants, suggesting that infections may have occurred before starting PrEP, rather than as a result of low adherence to the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women.Grant, RM., Liegler, T., Defechereux, P., et al.[2022]

In a study of women aged 18-35 in Durban, South Africa, daily oral PrEP (tenofovir disoproxil fumarate/emtricitabine) showed an overall mean adherence of 63%, highlighting the importance of adherence for effective HIV prevention during periconception.

Four distinct adherence patterns were identified: high steady adherence (22%), moderate steady adherence (31%), initially high but declining adherence (21%), and initially moderate with a rebound (26%), suggesting that targeted strategies are needed to maintain high adherence levels over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to daily, oral TDF/FTC PrEP during periconception among HIV-exposed South African women.Hurwitz, KE., Isehunwa, OO., Hendrickson, KR., et al.[2023]

Citations

1.reporter.nih.govreporter.nih.gov/search/3IUGDsMY9kOKHYPzjarW9g/project-details/10468388

Smart Steps - NIH RePORTERWe will utilize a digital phenotyping app, Beiwe, which securely and anonymously collects raw smartphone use data. We will recruit N=40 MSM with substance ...

2.hsph.harvard.eduhsph.harvard.edu/research/onnela-lab/digital-phenotyping-and-beiwe-research-platform/

Digital Phenotyping and Beiwe Research PlatformWe define digital phenotyping as the “moment-by-moment quantification of the individual-level human phenotype in situ using data from personal digital devices,” ...

3.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC10883553/

Acceptance of digital phenotyping linked to a digital pill ...Acceptance of digital phenotyping linked to a digital pill system to measure PrEP adherence among men who have sex with men with substance use.

4.medrxiv.orgmedrxiv.org/content/10.1101/2022.05.17.22275182v1.full-text

Increasing the Value of Digital Phenotyping Through ...Digital phenotyping data quality is a moving target that requires ongoing technical and protocol efforts to minimize missingness.

5.researchgate.netresearchgate.net/publication/378712717_Smartphone_and_Wearable_Device-Based_Digital_Phenotyping_to_Understand_Substance_use_and_its_Syndemics

Smartphone and Wearable Device-Based Digital ...Daily oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, though efficacy depends on adherence. Digital pill ...

6.hsph.harvard.eduhsph.harvard.edu/research-resource/beiwe/

Beiwe Service CenterThe Beiwe Service Center enables researchers to access the open‑source Beiwe platform for smartphone‑based digital phenotyping—complete with Android/iOS apps ...

7.journals.sagepub.comjournals.sagepub.com/doi/10.1177/14614448231158653

mHealth and social mediation: Mobile support among ...In this study, we examined the use and utility of one such app designed to support people living with HIV (PLWH) and SUD.

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