eSTEP for Pre-Exposure Prophylaxis

(eSTEP Trial)

Overseen By Donovan W Ackley III, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: San Diego State University

Must be taking: PrEP

Disqualifiers: HIV, Under 18, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The long-term goal of this research is to develop a theoretically grounded, effective, accessible and sustainable mHealth PrEP care continuum intervention for racially/ethnically diverse transgender women (TW) and gay, bisexual, and other men who have sex with men (GBMSM) disproportionately impacted by the HIV epidemic. To reach this goal, the investigators will compare study outcomes among persons randomized to use a mobile app (eSTEP) intervention tailored to the unique needs of TW and GBMSM with interactive components delivered before in-person HIV testing and PrEP initiation visit and interactive components delivered after PrEP is initiated. The eSTEP group will be compared to usual HIV testing and PrEP care.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does require that you have not used PrEP in the past 3 months.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not be currently taking PrEP to participate.

What data supports the idea that eSTEP for Pre-Exposure Prophylaxis is an effective treatment?

The available research does not provide any data or studies specifically about eSTEP for Pre-Exposure Prophylaxis. The articles focus on other topics such as hazardous substance exposure prevention, leprosy control, and organophosphate exposure, but none of them discuss eSTEP or its effectiveness. ^{1 2 3 4 5}

What safety data exists for eSTEP PrEP treatment?

The safety data for eSTEP PrEP treatment, which involves the use of tenofovir disoproxil fumarate/emtricitabine (Truvada), indicates a good safety profile based on clinical trials. The main adverse effects are mild to moderate gastrointestinal issues like nausea, vomiting, and diarrhea. Monitoring of liver enzymes, renal function, and bone mineral density is recommended to prevent long-term toxic effects. Regular adherence monitoring and real-world safety surveillance are critical to ensure the benefits observed in clinical trials are maintained in real-world use. ^{6 7 8 9 10}

Is the eSTEP intervention for PrEP generally safe for humans?

The eSTEP intervention, which involves the use of mobile apps to support PrEP (pre-exposure prophylaxis) for HIV prevention, is generally considered safe. PrEP itself, using medications like tenofovir disoproxil fumarate/emtricitabine, has a good safety profile with mild to moderate side effects such as nausea, vomiting, and diarrhea. Regular monitoring is recommended to prevent long-term effects on liver, kidneys, and bones. ^{6 7 8 9 10}

Is the eSTEP mobile app a promising treatment for preventing HIV?

The eSTEP mobile app is a promising treatment because it helps people connect to and continue using PrEP, a method that prevents HIV. This can make it easier for people to stay protected and reduce the spread of HIV. ^{10 11 12 13 14}

How is the eSTEP treatment for PrEP different from other treatments?

The eSTEP treatment is unique because it involves a mobile app intervention, which is different from traditional PrEP treatments that typically involve taking a combination of antiretroviral drugs. This app-based approach may offer a novel way to support adherence and engagement with PrEP, potentially improving its effectiveness. ^{10 11 12 13 14}

Research Team

Keith J Horvath, PhD

Principal Investigator

San Diego State University

Susan J Little, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for English-speaking transgender women and gay/bisexual men over 18 who are HIV-negative, own a smartphone, and have not used PrEP in the past 3 months. They must be eligible for PrEP per CDC guidelines, which includes having an HIV-positive partner or a recent STI.

Inclusion Criteria

I agree to let the study team see my health information.

I have never used PrEP or haven't used it in the last 3 months.

I identify as a man, a gay or bisexual man, or I am transfeminine.

Exclusion Criteria

Living with HIV

I was assigned female or intersex at birth.

Does not own a mobile phone

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Assessment

Participants complete an online baseline survey and schedule an in-person clinical appointment for routine HIV testing and PrEP eligibility screening

1 week

1 visit (in-person)

Treatment

Participants receive the eSTEP intervention or usual care, with follow-up assessments at 12 and 24 weeks

24 weeks

2 visits (in-person), 2 visits (virtual)

Follow-up

Participants are monitored for PrEP adherence and persistence, with exit interviews for selected participants in the eSTEP intervention arm

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• eSTEP

Trial Overview The eSTEP study tests a mobile app designed to help at-risk individuals start and stick with Pre-Exposure Prophylaxis (PrEP) to prevent HIV. Participants will either use this new app along with their usual care or just receive the usual care without the app.

Participant Groups

Group I: eSTEP Treatment Group Active Control 1 Intervention

Treatment group participants will be given access to eSTEP (Electronic Support to Engage with PrEP), an mHealth intervention to promote engagement on the full PrEP care continuum tailored to the unique needs of transgender women (TW) and gay, bisexual, and other men who have sex with men (GBMSM), in addition to the usual HIV testing and PrEP clinical care.

Group II: Control Arm Placebo Group 1 Intervention

Usual HIV testing and PrEP clinical care

eSTEP is already approved in United States for the following indications:

Approved in United States as eSTEP for:

• HIV prevention in high-risk individuals

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Findings from Research

A review of 36,183 chlorpyrifos (CP) exposure inquiries over a 10-year period revealed that 95.8% of cases assessed as causally related to CP resulted in no significant health effects, indicating a high safety profile for most exposures.

Only a small fraction of cases required specific antidotes, with atropine used in 1.0% and 2-PAM in 0.5% of cases, suggesting that severe outcomes from CP exposure are rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorpyrifos: a ten-year US poison center exposure experience. Kingston, RL., Chen, WL., Borron, SW., et al.[2013]

Post-exposure chemoprophylaxis (PEP) for leprosy contacts could be beneficial, but the exact number of contacts needed to prevent one case is difficult to generalize from existing studies.

Implementing PEP in Brazil should begin on a small scale, particularly in areas covered by the family health program, with careful monitoring for feasibility and effectiveness before wider application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CHEMOPROPHYLAXIS TO CONTROL LEPROSY AND THE PERSPECTIVE OF ITS IMPLEMENTATION IN BRAZIL: A PRIMER FOR NON-EPIDEMIOLOGISTS. Cunha, SS., Bierrenbach, AL., Barreto, VH.[2018]

The ATNAA auto-injector significantly reduces the time required to administer organophosphate antidotes compared to traditional needle/syringe methods, taking less than half the time for a single injection.

There was no significant difference in administration time between the Mark I auto-injector and traditional needle/syringe, indicating that while auto-injectors are faster, the Mark I is comparable to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organophosphate antidote auto-injectors vs. traditional administration: a time motion study. Rebmann, T., Clements, BW., Bailey, JA., et al.[2012]

A 16-month management-focused intervention in 15 large manufacturing worksites showed patterns of improvement in exposure prevention (EP) ratings, indicating that systematic assessments can effectively evaluate hazardous substance exposures.

While the intervention led to greater improvements in EP ratings compared to control sites, the difference was moderate and not statistically significant, suggesting that more intense or sustained interventions may be needed for significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the prevention and control of hazardous substance exposures: a randomized controlled trial in manufacturing worksites. Lamontagne, AD., Stoddard, AM., Youngstrom, RA., et al.[2007]

The study evaluated toxicity data for 30 organophosphate pesticides to suggest inhalation occupational exposure limits (OELs), which range from 0.002 to 2 mg/m³, often lower than current permissible exposure levels.

It was found that acute toxicity measures and repeated oral exposure NOELs do not reliably predict inhalation OELs, indicating the need for a comprehensive risk assessment approach that considers various exposure durations and routes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational exposure limits for 30 organophosphate pesticides based on inhibition of red blood cell acetylcholinesterase. Storm, JE., Rozman, KK., Doull, J.[2022]

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]

In a study of 46,706 high-risk adult men, PrEP (pre-exposure prophylaxis) demonstrated an overall effectiveness of 60% in preventing HIV infection, with effectiveness increasing to 93% for those with high PrEP consumption.

The effectiveness of PrEP was notably lower in younger individuals (26%) and those from socioeconomically deprived backgrounds (-64%), highlighting the need for improved adherence and monitoring strategies in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of pre-exposure prophylaxis in men at high risk of HIV infection in France: a nested case-control study. Jourdain, H., de Gage, SB., Desplas, D., et al.[2022]

The SwissPrEPared national pre-exposure prophylaxis (PrEP) program demonstrated high feasibility with a participation rate of 98.2% and a median enrolment rate of 86 individuals per month, indicating strong interest in PrEP among eligible individuals.

Retention at first follow-up and uptake were both 80.7%, suggesting that once enrolled, participants were committed to the program, particularly those at higher risk of HIV infection, although younger and less educated individuals were less represented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation, retention and uptake in a multicentre pre-exposure prophylaxis cohort using online, smartphone-compatible data collection. Hovaguimian, F., Martin, E., Reinacher, M., et al.[2022]

A systematic search identified only 11 out of 621 mobile apps that effectively support the uptake and adherence of PrEP, indicating a significant gap in available resources for at-risk individuals.

The evaluated apps showed moderate effectiveness in facilitating PrEP use by providing essential information and resources, and they received an acceptable quality rating, suggesting they could help increase PrEP uptake among those at risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. Sharpe, JD., Kamara, MT.[2019]

A review of 808 cases of pre-exposure prophylaxis (PrEP) using TDF/FTC revealed that the most common adverse effects (AEs) were gastrointestinal issues, such as nausea, vomiting, and diarrhea, which aligns with known side effects in HIV-infected populations.

Despite identifying 24% of unexpected adverse effects, including serious ones primarily among chemsex users, the overall data supports the safety of PrEP, indicating it is a viable option for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?] Jacomet, C., Lebeller, C., Schiestel, T., et al.[2022]

Pre-exposure prophylaxis (PrEP) is being evaluated as a risk reduction tool for preventing HIV transmission in France, despite not having market authorization yet.

The article discusses ongoing studies that aim to assess the efficacy and safety of PrEP, highlighting its potential as an important intervention in public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Focus on pre-exposure prophylaxis]. Torres, E., Meynard, JL.[2013]

In 2019, an estimated 142,379 HIV-negative men who have sex with men (MSM) in France were eligible for pre-exposure prophylaxis (PrEP) based on official criteria, highlighting a significant population that could benefit from this preventive measure.

The estimated cost of rolling out PrEP for eligible MSM in France ranges from approximately €317 million to €546 million, indicating a substantial financial investment needed for effective implementation and suggesting the importance of policy decisions to facilitate access and awareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis in France: How many MSM are eligible and how much will it cost? Ousseine, YM., Lydié, N., Velter, A.[2023]

Health facility-based integrated models of PrEP delivery, especially when combined with family planning and maternal health services, led to a high initiation rate of PrEP among adolescent girls and young women, ranging from 16% to 90%.

Community-based drop-in centers were the preferred option for PrEP access among adolescent girls and young women, with 66% favoring this model over public and private clinics, highlighting the importance of tailoring PrEP service delivery models to meet the specific needs and preferences of different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Service delivery models that promote linkages to PrEP for adolescent girls and young women and men in sub-Saharan Africa: a scoping review. Ramraj, T., Chirinda, W., Jonas, K., et al.[2023]

In a study involving 544 participants, 76% completed acceptability questionnaires, revealing that most found the open-label wait-listed trial design acceptable, particularly regarding their satisfaction and intention to remain in the study.

While the majority understood the rationale for the deferred access to PrEP, about 75% expressed concern that being in the deferred group might deter others from joining, indicating a need for careful communication about study design to potential participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study. Gafos, M., Brodnicki, E., Desai, M., et al.[2023]

References

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

Chlorpyrifos: a ten-year US poison center exposure experience. [2013]

2. Brazil pubmed.ncbi.nlm.nih.gov

CHEMOPROPHYLAXIS TO CONTROL LEPROSY AND THE PERSPECTIVE OF ITS IMPLEMENTATION IN BRAZIL: A PRIMER FOR NON-EPIDEMIOLOGISTS. [2018]

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

Organophosphate antidote auto-injectors vs. traditional administration: a time motion study. [2012]

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

Improving the prevention and control of hazardous substance exposures: a randomized controlled trial in manufacturing worksites. [2007]

5. Ireland pubmed.ncbi.nlm.nih.gov

Occupational exposure limits for 30 organophosphate pesticides based on inhibition of red blood cell acetylcholinesterase. [2022]

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

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of pre-exposure prophylaxis in men at high risk of HIV infection in France: a nested case-control study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Participation, retention and uptake in a multicentre pre-exposure prophylaxis cohort using online, smartphone-compatible data collection. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. [2019]

10. France pubmed.ncbi.nlm.nih.gov

[HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?] [2022]

11. France pubmed.ncbi.nlm.nih.gov

[Focus on pre-exposure prophylaxis]. [2013]

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

Pre-exposure prophylaxis in France: How many MSM are eligible and how much will it cost? [2023]

13. England pubmed.ncbi.nlm.nih.gov

Service delivery models that promote linkages to PrEP for adolescent girls and young women and men in sub-Saharan Africa: a scoping review. [2023]

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

Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study. [2023]