HIV/AIDSNCT05111119
Making PrEP Smart: An HIV Testing and PrEP Electronic Support Tool ("SmartPrEP" App) for Women on PrEP
A study testing Making PrEP Smart in people with HIV/AIDS, run by Columbia University at 1 site in United States.
Trial summary
Primary Objective: To assess PrEP adherence among sexually-active and/or injection-drug using, HIV-negative cis- and transgender women who use the "SmartPrEP" phone app to support PrEP adherence during a 12-month period of observation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Making PrEP Smart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2022to 22 Aug 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older (confirmed by ID)
- self-identify as either a cisgender or transgender woman
- eligible for and willing to initiate PrEP or already on PrEP [having initiated PrEP within the last three months per participant self-report]
- documented negative HIV test result at Screening Visit
- Has a mobile phone with a minimum of 3G network with an active cellular plan
- no signs/symptoms of acute HIV infection
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- normal renal function (eCrCl of >/= 60 ml/min)
- not taking contraindicated medications
- documented negative hepatitis B virus (HBVAg) status or documented evidence of seroimmunity
- if HCV Ab positive, documented evidence of previous completed treatment, resolution of active HCV infection (i.e. documented negative HCV RNA), or documented evidence of PCP/HCV care provider management/treatment progress
- meets CDC criteria for HIV risk
- willing to complete all required study procedures including the use of Truvada.
Who cannot join
- age under 18 years;
- HIV-positive status based on documented test results at at Screening or Enrollment Visits;
- any sign or symptom of acute HIV infection at screening or enrollment visit, until HIV status is confirmed negative via HIV RNA PCR testing;
- renal function, eCrCl< 60 mL/min at Screening or Enrollment visit;
- inability to provide informed consent;
- pregnancy or breast-feeding;
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- plans to move away from NYC area in the next 12-month period;
- Current use of HIV post-exposure prophylaxis (PEP), though participants who wish to transition from PEP to PrEP will be eligible at the completion of PEP
- Continued need for/use of medications with potential for adverse interactions with Truvada (FTC/TDF) or Descovy (TAF/FTC) on a case-by-case basis, i.e., hepatitis C antiviral agents, such as EPCLUSA (sofosbuvir/velpatasvir) or VOSEVI (sofosbuvir/velpatasvir/voxilaprevir); NRTIs, such as didanosine; medications that may decrease renal function (i.e., high-dose or multiple NSAIDS, aminoglycosides; and other medications that may result in compromising a participant's overall health if combined with Truvada, per the discretion of the IOR;
- History of self-reported low adherence to PrEP, based on study team's judgement
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Primary Objective: To assess PrEP adherence among sexually-active and/or injection-drug using, HIV-negative cis- and transgender women who use the "SmartPrEP" phone app to support PrEP adherence during a 12-month period of observation.
Secondary Objective: To assess the acceptability of using the SmartPrEP app to support HIV self-testing and partner testing among sexually active and/or injection-drug using, HIV-negative cisgender and transgender women on PrEP.
Exploratory Objectives: To describe patterns of PrEP adherence and user feedback on acceptability, utility, and features of the app; To assess correlations between self-reported sexual behavior and PrEP adherence; To assess patterns of HIV testing (self and partner testing), self-reported reasons for HIV testing, and correlations with test results.
Read the detailed description
The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self-testing and PrEP adherence among cisgender and transgender women over a twelve-month period. As part of this, participants will be required to download the SmartPrEP app and participate in six study visits starting at enrollment, Month 1, Month 3, Month 6, Month 9, and Month 12. Most visits will take place at the Bronx Prevention Center and include adherence counseling, app acceptability assessments, behavioral risk assessments, and STI/HIV testing. App data will be collected which evaluates PrEP adherence, HIV self-testing, and HIV partner testing. Additionally, all participants will be invited to take part in either a focus group discussion (FGD) or an open-ended, in-depth interview (IDI) to elicit their thoughts and preferences regarding the SmartPrEP app acceptability. Interventions consist of (1) smartphone app "SmartPrEP"; (2) PrEP medication.
- Conditions
- HIV/AIDS
- Being tested
- Making PrEP Smart
- Keywords
- Pre-Exposure Prophylaxis (PrEP), HIV Prevention, Mobile App
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making PrEP SmartBehavioural
The Making PrEP Smart intervention is a mobile-based application with the following components:
- Notification-based PrEP Reminders and Adherence Self-Monitoring
- HIV self-testing facilitation, interpretation of results, and testing support
- HIV partner testing facilitation, interpretation of results, and testing support
- Nearby HIV clinic contact information
| Study group | Role | What they receive |
|---|---|---|
| Making PrEP Smart | Experimental | The Making PrEP Smart intervention is a mobile-based application which provides PrEP adherence reminders and supports HIV-self and partner testing for cis- and transgender women. Receives: Behavioral: Making PrEP Smart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with optimal PrEP adherence
This is to measure PrEP Adherence, defined as taking >/= 6 doses per week, as recorded in the SmartPrEP app.
Measured: 12-month period of observation
Secondary outcomes (2)
Proportion of participants who perform HIV self-testing
This is to measure HIV Self-Testing, as recorded in the SmartPrEP App during the study. Participant-reported reasons for performing HIV self-testing will be included in the analyses.
Measured: 12-month period of observation
Proportion of participants who rated app to be acceptable
This is to measure acceptability of the SmartPrEP App, per participant report, as collected in the focus group discussions and in-depth interviews.
Measured: 12-month period of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start3 Feb 2022
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Jessica Justman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111119
- Sponsor's protocol ID
- AAAT7092
- Status last verified
- May 2025
- First submitted
- 27 Oct 2021
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wright CG, Chern TL, Abularrage TF, Franks J, Kahn A, Edwards S, Chellani HH, Redd R, Ying AW, Arumugam S, Stanciu R, Sia SK, Morrison EA, Justman JE. Pre-Exposure Prophylaxis Adherence and HIV Self-Testing App Among Women in the South Bronx: 12-Month Usability, Acceptability, and Feasibility Study. JMIR Form Res. 2026 Jun 2;10:e86407. doi: 10.2196/86407.
PubMed 42228898
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making PrEP Smart: An HIV Testing and PrEP Electronic Support Tool ("SmartPrEP" App) for Women on PrEP
- ClinicalTrials.gov ID
- NCT05111119
- Acronym / sponsor ID
- AAAT7092
- Conditions
- HIV/AIDS
- Keywords
- Pre-Exposure Prophylaxis (PrEP), HIV Prevention, Mobile App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 8 Nov 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.
Primary Objective: To assess PrEP adherence among sexually-active and/or injection-drug using, HIV-negative cis- and transgender women who use the "SmartPrEP" phone app to support PrEP adherence during a 12-month period of observation.
Secondary Objective: To assess the acceptability of using the SmartPrEP app to support HIV self-testing and partner testing among sexually active and/or injection-drug using, HIV-negative cisgender and transgender women on PrEP.
Exploratory Objectives: To describe patterns of PrEP adherence and user feedback on acceptability, utility, and features of the app; To assess correlations between self-reported sexual behavior and PrEP adherence; To assess patterns of HIV testing (self and partner testing), self-reported reasons for HIV testing, and correlations with test results.
Detailed description
The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self-testing and PrEP adherence among cisgender and transgender women over a twelve-month period. As part of this, participants will be required to download the SmartPrEP app and participate in six study visits starting at enrollment, Month 1, Month 3, Month 6, Month 9, and Month 12. Most visits will take place at the Bronx Prevention Center and include adherence counseling, app acceptability assessments, behavioral risk assessments, and STI/HIV testing. App data will be collected which evaluates PrEP adherence, HIV self-testing, and HIV partner testing. Additionally, all participants will be invited to take part in either a focus group discussion (FGD) or an open-ended, in-depth interview (IDI) to elicit their thoughts and preferences regarding the SmartPrEP app acceptability. Interventions consist of (1) smartphone app "SmartPrEP"; (2) PrEP medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Making PrEP Smart | Experimental | Behavioral: Making PrEP SmartThe Making PrEP Smart intervention is a mobile-based application which provides PrEP adherence reminders and supports HIV-self and partner testing for cis- and transgender women. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age 18 years or older (confirmed by ID)
- self-identify as either a cisgender or transgender woman
- eligible for and willing to initiate PrEP or already on PrEP [having initiated PrEP within the last three months per participant self-report]
- documented negative HIV test result at Screening Visit
- Has a mobile phone with a minimum of 3G network with an active cellular plan
Key exclusion criteria (10 listed)
- age under 18 years;
- HIV-positive status based on documented test results at at Screening or Enrollment Visits;
- any sign or symptom of acute HIV infection at screening or enrollment visit, until HIV status is confirmed negative via HIV RNA PCR testing;
- renal function, eCrCl< 60 mL/min at Screening or Enrollment visit;
- inability to provide informed consent;
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 |
|---|---|---|
| Making PrEP SmartThe Making PrEP Smart intervention is a mobile-based application with the following components: * Notification-based PrEP Reminders and Adherence Self-Monitoring * HIV self-testing facilitation, interpretation of results, and testing support * HIV partner testing facilitation, interpretation of results, and testing support * Nearby HIV clinic contact information | Behavioural | Making PrEP Smart |
Primary outcome
Proportion of participants with optimal PrEP adherence
Time frame: 12-month period of observation
This is to measure PrEP Adherence, defined as taking >/= 6 doses per week, as recorded in the SmartPrEP app.
2 secondary outcomes
Proportion of participants who perform HIV self-testing
Time frame: 12-month period of observation
Proportion of participants who rated app to be acceptable
Time frame: 12-month period of observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Derived from this study: PubMed 42228898Wright CG, Chern TL, Abularrage TF, Franks J, Kahn A, Edwards S, Chellani HH, Redd R, Ying AW, Arumugam S, Stanciu R, Sia SK, Morrison EA, Justman JE. Pre-Exposure Prophylaxis Adherence and HIV Self-Testing App Among Women in the South Bronx: 12-Month Usability, Acceptability, and Feasibility Study. JMIR Form Res. 2026 Jun 2;10:e86407. doi: 10.2196/86407.
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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.
Jessica Justman, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Making PrEP Smart in people with HIV/AIDS, run by Columbia University 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 12 inclusion and 10 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: finished, as of the sponsor's last update on 9 May 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants with optimal PrEP adherence (time frame: 12-month period of observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05111119, which also lists 1 linked publication.
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 9 May 2025.