Pre-Exposure ProphylaxisSMART PrEPNCT04990583
mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence
A study testing Face-to-Face PrEP Adherence Intervention Based on LifeSteps and Adherence Coaching Facilitated by Carium Adherence App in people with Pre-Exposure Prophylaxis and Telemedicine, run by Rhode Island Hospital at 1 site in United States.
Trial summary
If taken every day, PrEP is an effective method for preventing HIV. However, many prescribed PrEP in the U.S. do not take it every day, as prescribed. The goal of this study is to develop and test an intervention, facilitated by a mobile app, meant to improve adherence to PrEP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-Exposure Prophylaxis, Telemedicine, Medication Adherence
- What is being tested?
- Face-to-Face PrEP Adherence Intervention Based on LifeSteps and Adherence Coaching Facilitated by Carium Adherence App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Jul 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age,
- has a prescription for PrEP
- received first prescription for PrEP at least one month ago
- reports taking an average of fewer than 6 PrEP doses per week of over the past month
- has phone that is compatible with the Carium app.
Who cannot join
- cognitive impairment that would jeopardize informed consent and/or intervention comprehension
- active psychosis
- not fluent in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
If taken every day, PrEP is an effective method for preventing HIV. However, many prescribed PrEP in the U.S. do not take it every day, as prescribed. The goal of this study is to develop and test an intervention, facilitated by a mobile app, meant to improve adherence to PrEP. To that end, 60 individuals prescribed PrEP who do not take their PrEP every day as prescribed will be recruited. Participants will complete an initial research interview, receive a one-on-one PrEP adherence session with an adherence coach, and complete follow-up interviews at 1, 3, 6, and 12 months. In addition, some participants will be randomized to receive access to a mobile app and adherence coaching via the app for 12-months. The primary outcome is self-reported adherence to PrEP. This study will examine whether this intervention is effective at improving adherence to PrEP, is feasible to use, and found acceptable by those who use it.
Read the detailed description
HIV pre-exposure prophylaxis (PrEP), involves the use of antiretroviral (ART) medications (Truvada or Descovy) by persons uninfected with HIV to prevent HIV acquisition. The efficacy of PrEP for preventing HIV acquisition is highly impacted by one's medication adherence. Within the U.S., adherence to PrEP is suboptimal. Commonly cited barriers to PrEP adherence include forgetfulness, low HIV risk perception, stigma, and cost. There is a need for interventions that improve adherence to PrEP, are readily disseminable, and that make efficient use of resources. To that end the current project will examine the feasibility, acceptability, and preliminary efficacy of an intervention tailored for PrEP adherence, facilitated by mHealth. Individuals prescribed PrEP (n = 60) who report taking, on average, fewer than 6 doses per week in the past month will be recruited. Participants will be randomly assigned to the intervention (Carium) or control condition. Data collection will consist of a baseline interview and follow-ups at 1, 3, 6, and 12 months. The primary outcome is PrEP adherence. PrEP adherence will be measured via self-report, pill counts, and use of a urine test developed by UrSure. The urine test is for research use only and will only be used to detect the presence of PrEP in urine if participants self-report taking PrEP in the last 48 hours. It is expected that participants in the Carium condition, relative to control, will report better adherence to PrEP.
- Conditions
- Pre-Exposure Prophylaxis, Telemedicine, Medication Adherence
- Being tested
- Face-to-Face PrEP Adherence Intervention Based on LifeSteps, Adherence Coaching Facilitated by Carium Adherence App
- Keywords
- PrEP, Adherence, mHealth
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-Face PrEP Adherence Intervention Based on LifeStepsBehavioural
This single session intervention, based on LifeSteps, will occur with a study adherence coach either in-person or remotely via HIPAA compliant videoconferencing software. The topics covered during the session will include: experience taking PrEP, risk behavior education, mental health and substance use as barriers to adherence, other barriers to adherence, formulating a dosing schedule, storing and transporting medications, and response to slips in adherence. Participants assigned to the Carium condition will also receive an introduction to the Carium app.
Adherence Coaching Facilitated by Carium Adherence AppBehavioural
The Carium app will be used to deliver medication reminders to participants, track medication adherence, engage in two-way secure messaging with participants, and connect with participants through a secure video feature. The adherence coach will use the secure messaging feature to support the participant with their adherence
| Study group | Role | What they receive |
|---|---|---|
| Carium Condition | Experimental | Participants assigned to the Carium condition will receive a single session intervention and receive 12 months of access to the Carium adherence application. Receives: Behavioral: Face-to-Face PrEP Adherence Intervention Based on LifeSteps; Behavioral: Adherence Coaching Facilitated by Carium Adherence App |
| Control Condition | Active comparator | Participants assigned to the Control condition will receive a single session intervention only. Receives: Behavioral: Face-to-Face PrEP Adherence Intervention Based on LifeSteps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PrEP Adherence
PrEP adherence will be measured via self-report and confirmed by examining concentration of PrEP in participants' urine.
Measured: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Secondary outcomes (9)
Pill counts
Pill counts of PrEP medication will occur in-person or remotely. Date of prescription will be compared to the number of pills remaining.
Measured: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
PrEP Care Retention
Medical records will be examined to confirm retention in PrEP care. PrEP care retention will be defined as attending 3-month clinical appointments (+/- 1 month). This information will be extracted from participants' medical records at the 12-month follow-up.
Measured: 12-month follow-up.
HIV/STI Status
Results of HIV and STI tests will be extracted from participants' medical records.
Measured: Baseline and 12-month follow-up.
Alcohol and Drug Use
Daily alcohol and drug use will be assessed with the Timeline Followback (TLFB). The TLFB will provide data on the number of standard drinks consumed per day and types of drug classes used each day.
Measured: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
HIV Risk Behavior
The Timeline Followback interview will be used to assess daily drug and sex risk behavior. In addition, the HIV Risk Assessment Battery (RAB) will serve as a measure of overall sex and drug risk.
Measured: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Center for Epidemiologic Studies Depression Scale (CES-D)
The CESD will be used to measure level of depressive symptoms. This measure is widely used and has good sensitivity and specificity and high internal consistency.
Measured: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
PrEP Care Dropout and Non-Adherence
Participants who have dropped out of PrEP care or report a period of non-adherence, will be asked open-ended questions at the 12-month follow-up to assess the reasons for treatment dropout and/or non-adherence.
Measured: 12-month follow-up.
Treatment Received
Receipt of case management, psychiatric, substance use, and other treatment services will be assessed with the Treatment Services Review.
Measured: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Medications
Participants will also be asked about their use of medications for medical, psychiatric, or substance use indications.
Measured: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Mar 2021
- Primary completion31 Mar 2022
- Study completion31 Jul 2022
Why it stopped: Unable to enroll participants during COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure ProphylaxisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990583
- Sponsor's protocol ID
- 012820
- Acronym
- SMART PrEP
- Status last verified
- Nov 2020
- First submitted
- 8 Mar 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence
- ClinicalTrials.gov ID
- NCT04990583
- Acronym / sponsor ID
- SMART PrEP / 012820
- Conditions
- Pre-Exposure Prophylaxis, Telemedicine, Medication Adherence
- Keywords
- PrEP, Adherence, mHealth
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll participants during COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 4 Aug 2021 (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.
If taken every day, PrEP is an effective method for preventing HIV. However, many prescribed PrEP in the U.S. do not take it every day, as prescribed. The goal of this study is to develop and test an intervention, facilitated by a mobile app, meant to improve adherence to PrEP. To that end, 60 individuals prescribed PrEP who do not take their PrEP every day as prescribed will be recruited. Participants will complete an initial research interview, receive a one-on-one PrEP adherence session with an adherence coach, and complete follow-up interviews at 1, 3, 6, and 12 months. In addition, some participants will be randomized to receive access to a mobile app and adherence coaching via the app for 12-months. The primary outcome is self-reported adherence to PrEP. This study will examine whether this intervention is effective at improving adherence to PrEP, is feasible to use, and found acceptable by those who use it.
Detailed description
HIV pre-exposure prophylaxis (PrEP), involves the use of antiretroviral (ART) medications (Truvada or Descovy) by persons uninfected with HIV to prevent HIV acquisition. The efficacy of PrEP for preventing HIV acquisition is highly impacted by one's medication adherence. Within the U.S., adherence to PrEP is suboptimal. Commonly cited barriers to PrEP adherence include forgetfulness, low HIV risk perception, stigma, and cost. There is a need for interventions that improve adherence to PrEP, are readily disseminable, and that make efficient use of resources. To that end the current project will examine the feasibility, acceptability, and preliminary efficacy of an intervention tailored for PrEP adherence, facilitated by mHealth. Individuals prescribed PrEP (n = 60) who report taking, on average, fewer than 6 doses per week in the past month will be recruited. Participants will be randomly assigned to the intervention (Carium) or control condition. Data collection will consist of a baseline interview and follow-ups at 1, 3, 6, and 12 months. The primary outcome is PrEP adherence. PrEP adherence will be measured via self-report, pill counts, and use of a urine test developed by UrSure. The urine test is for research use only and will only be used to detect the presence of PrEP in urine if participants self-report taking PrEP in the last 48 hours. It is expected that participants in the Carium condition, relative to control, will report better adherence to PrEP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carium Condition | Experimental | Behavioral: Face-to-Face PrEP Adherence Intervention Based on LifeSteps, Behavioral: Adherence Coaching Facilitated by Carium Adherence AppParticipants assigned to the Carium condition will receive a single session intervention and receive 12 months of access to the Carium adherence application. |
| Control Condition | Active comparator | Behavioral: Face-to-Face PrEP Adherence Intervention Based on LifeStepsParticipants assigned to the Control condition will receive a single session intervention only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 18 years of age,
- has a prescription for PrEP
- received first prescription for PrEP at least one month ago
- reports taking an average of fewer than 6 PrEP doses per week of over the past month
- has phone that is compatible with the Carium app.
Key exclusion criteria (3 listed)
- cognitive impairment that would jeopardize informed consent and/or intervention comprehension
- active psychosis
- not fluent in English.
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 |
|---|---|---|
| Face-to-Face PrEP Adherence Intervention Based on LifeStepsThis single session intervention, based on LifeSteps, will occur with a study adherence coach either in-person or remotely via HIPAA compliant videoconferencing software. The topics covered during the session will include: experience taking PrEP, risk behavior education, mental health and substance use as barriers to adherence, other barriers to adherence, formulating a dosing schedule, storing and transporting medications, and response to slips in adherence. Participants assigned to the Carium condition will also receive an introduction to the Carium app. | Behavioural | Carium Condition, Control Condition |
| Adherence Coaching Facilitated by Carium Adherence AppThe Carium app will be used to deliver medication reminders to participants, track medication adherence, engage in two-way secure messaging with participants, and connect with participants through a secure video feature. The adherence coach will use the secure messaging feature to support the participant with their adherence | Behavioural | Carium Condition |
Primary outcome
Change in PrEP Adherence
Time frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
PrEP adherence will be measured via self-report and confirmed by examining concentration of PrEP in participants' urine.
9 secondary outcomes
Pill counts
Time frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
PrEP Care Retention
Time frame: 12-month follow-up.
HIV/STI Status
Time frame: Baseline and 12-month follow-up.
Alcohol and Drug Use
Time frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
HIV Risk Behavior
Time frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
PrEP Care Dropout and Non-Adherence
Time frame: 12-month follow-up.
Treatment Received
Time frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Medications
Time frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Related trials for Pre-Exposure Prophylaxis
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face PrEP Adherence Intervention Based on LifeSteps and Adherence Coaching Facilitated by Carium Adherence App in people with Pre-Exposure Prophylaxis and Telemedicine, run by Rhode Island Hospital at 1 site 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PrEP Adherence (time frame: Baseline, 1-, 3-, 6-, and 12-month follow-ups.). 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 5 Apr 2023.