HIV PreventionPrEP-3D RCTNCT05474313
A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW
A study testing PrEP-3D package in people with HIV Prevention and Pre-exposure Prophylaxis (PrEP), run by Public Health Foundation Enterprises, Inc. at 2 sites in United States.
Trial summary
The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Pre-exposure Prophylaxis (PrEP), Risk Reduction
- What is being tested?
- PrEP-3D package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Assigned male at birth who reports sex with persons assigned male at birth
- Willing and able to provide written informed consent
- HIV-uninfected by negative 4th generation HIV test during screening
- Owns a smartphone and has private access to the internet
- Able to understand, read, and speak English or Spanish
Show all 14Show fewer
- Lives in California
- Self-reported evidence of being at-risk for HIV acquisition, including at least one of the following in the past 6 months:
- ≥ 1 episode of anal/vaginal sex with a male or transgender female partner;
- Diagnosed with a bacterial sexually transmitted infection (STI).
- Interested in taking daily TDF/FTC or TAF/FTC PrEP
- Willing and able to receive PrEP prescriptions through Alto Pharmacy (e.g., no specific pharmacy required by health plan, such as Kaiser HMO)
- Creatinine clearance >30 mL/min
- No contraindications to TDF/FTC or TAF/FTC use
Who cannot join
- Repeatedly reactive HIV test at screening or enrollment
- Signs or symptoms of acute HIV infection at screening or enrollment
- Currently enrolled in another HIV intervention study.
- Unable to commit to study participation for the duration of the study
- Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94102
Kenneth Coleman, MA, 628-217-7443, kenneth.coleman@sfdph.org
Susan Buchbinder, MD
- Active, not recruiting
Alto Pharmacy
San Francisco, California, 94107
About this study
Official title: PrEP-3D RCT: A Randomized Controlled Trial Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among Persons Assigned Male at Birth Who Have Sex With Persons Assigned Male at Birth
The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.
Read the detailed description
The investigators will be testing a pharmacist-led model of PrEP delivery combined with mobile app-based PrEP support developed by the investigator's team to improve PrEP initiation and persistence. Alto Pharmacy is a full-service online pharmacy already using mobile and web apps to communicate with patients, providers, laboratories, and insurers to provide timely medication delivery. Alto can provide PrEP prescriptions, order laboratory tests, and perform clinical referrals through a collaborative practice agreement (CPA) with SFDPH that allows transfer of these responsibilities. The investigators have integrated online tools with Alto Pharmacy's technology platform to create PrEP-3D: Digital Diary and Delivery, combining a tailored online support tool with the personalized service of a community pharmacy and the convenience of medication delivery. By removing the requirement for initiation and quarterly visits with a primary care physician for PrEP, the PrEP-3D model will expand access to PrEP visits (including for persons who choose not to go to their primary care provider for PrEP) and reduce burden on the health care system.
- Being tested
- PrEP-3D package, Standard of Care
- Keywords
- PrEP, pre-exposure prophylaxis (PrEP), Adherence, HIV Risk Reduction, Mobile App, Pharmacy
- Medical subject headings
- Risk Reduction Behavior, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP-3D packageBehavioural
A package of support tools for accessing, adhering to, and monitoring PrEP use, including Alto Pharmacy delivery services, PrEP-3D mobile app, and home laboratory testing.
Standard of CareBehavioural
Participants are given local standard of care navigation for initiation of PrEP
| Study group | Role | What they receive |
|---|---|---|
| PrEP-3D | Experimental | Use of Alto Pharmacy, PrEP-3D mobile app and home laboratory testing. Receives: Behavioral: PrEP-3D package |
| Control Arm | Other | Participants in the control arm will receive standard of care PREP navigation. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of PREP-3D on PREP use
Measurement of PrEP adherence using dried blood spot measurements of tenofovir-diphosphate (TFV-DP) levels greater than or equal to 700 fmol/punch
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start8 Apr 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Department of Public Health, Alto Pharmacy
- Responsible party
- Principal investigator, Susan Buchbinder, Public Health Foundation Enterprises, Inc.
- Investigators
- Susan Buchbinder, MD, Principal investigator, Bridge HIV, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474313
- Sponsor's protocol ID
- 21-35533
- Acronym
- PrEP-3D RCT
- Status last verified
- Sep 2022
- First submitted
- 22 Jul 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP-3D RCT: A Randomized Controlled Trial Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among Persons Assigned Male at Birth Who Have Sex With Persons Assigned Male at Birth
- ClinicalTrials.gov ID
- NCT05474313
- Acronym / sponsor ID
- PrEP-3D RCT / 21-35533
- Keywords
- PrEP, pre-exposure prophylaxis (PrEP), Adherence, HIV Risk Reduction, Mobile App, Pharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- Collaborators
- San Francisco Department of Public Health, Alto Pharmacy
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.
Detailed description
The investigators will be testing a pharmacist-led model of PrEP delivery combined with mobile app-based PrEP support developed by the investigator's team to improve PrEP initiation and persistence. Alto Pharmacy is a full-service online pharmacy already using mobile and web apps to communicate with patients, providers, laboratories, and insurers to provide timely medication delivery. Alto can provide PrEP prescriptions, order laboratory tests, and perform clinical referrals through a collaborative practice agreement (CPA) with SFDPH that allows transfer of these responsibilities. The investigators have integrated online tools with Alto Pharmacy's technology platform to create PrEP-3D: Digital Diary and Delivery, combining a tailored online support tool with the personalized service of a community pharmacy and the convenience of medication delivery. By removing the requirement for initiation and quarterly visits with a primary care physician for PrEP, the PrEP-3D model will expand access to PrEP visits (including for persons who choose not to go to their primary care provider for PrEP) and reduce burden on the health care system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| PrEP-3D | Experimental | Behavioral: PrEP-3D packageUse of Alto Pharmacy, PrEP-3D mobile app and home laboratory testing. |
| Control Arm | Other | Behavioral: Standard of CareParticipants in the control arm will receive standard of care PREP navigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18 years or older
- Assigned male at birth who reports sex with persons assigned male at birth
- Willing and able to provide written informed consent
- HIV-uninfected by negative 4th generation HIV test during screening
- Owns a smartphone and has private access to the internet
Key exclusion criteria (5 listed)
- Repeatedly reactive HIV test at screening or enrollment
- Signs or symptoms of acute HIV infection at screening or enrollment
- Currently enrolled in another HIV intervention study.
- Unable to commit to study participation for the duration of the study
- Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP-3D packageA package of support tools for accessing, adhering to, and monitoring PrEP use, including Alto Pharmacy delivery services, PrEP-3D mobile app, and home laboratory testing. | Behavioural | PrEP-3D |
| Standard of CareParticipants are given local standard of care navigation for initiation of PrEP | Behavioural | Control Arm |
Primary outcome
Effectiveness of PREP-3D on PREP use
Time frame: 12 months
Measurement of PrEP adherence using dried blood spot measurements of tenofovir-diphosphate (TFV-DP) levels greater than or equal to 700 fmol/punch
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Buchbinder, MD principal investigator
Bridge HIV, San Francisco Department of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP-3D package in people with HIV Prevention and Pre-exposure Prophylaxis (PrEP), run by Public Health Foundation Enterprises, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Coleman, MA (628-217-7443, kenneth.coleman@sfdph.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of PREP-3D on PREP use (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.