HIV InfectionsP2PNCT05281393
PrEP2Prevent An Online PrEP Navigation and Activation Intervention
A study testing PrEPresent in people with HIV Infections, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this clinical trial entitled, PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, is to develop and test a method for supporting access to an HIV prevention medication called Pre-Exposure Prophylaxis (PrEP) in young men who have sex with men and young transgender and non-binary… Read more about this study
- Who is it for?
- Ages 16 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- PrEPresent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 3 Jan 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 16 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- PrEP providers serving YMSM from healthcare and community-based organizations located in Los Angeles County or PrEP Navigators similarly employed by healthcare and community-based organizations that deliver PrEP services to YMSM.
- >18 years of age
- 16-26 years old
- cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
- identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with anyone with a penis during the previous 12 months
- identify as White/Caucasian, Black/African American, Latinx, Asian-Pacific Islander, Indigenous, Native American or mixed-race
Show all 18Show fewer
- living in the Los Angeles metro area
- have daily access to an iOS/Android smartphone and/or tablet with internet access
- know their HIV status and are HIV negative at time of enrollment.
- 16-26 years old
- cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
- identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with anyone with a penis during the previous 12 months
- identify as White/Caucasian, Black/African American, Hispanic/Latino/Latinx, or mixed-race
- living in the Los Angeles metro area
- have daily access to an iOS/Android smartphone and/or tablet with internet access
- report having insertive and/or receptive anal sex in the previous 6 months or report a positive STI result in the previous 6 months
- not currently on PrEP and no plan to start/restart PrEP in the following 7 days
- not currently enrolled in another HIV prevention study
Who cannot join
- Not a PrEP provider or navigator serving YMSM from healthcare and community-based organizations located in Los Angeles County
- under 18 years of age
- Phase 1B and Phase 2:
- is younger than or older than 16- to 26-years
- not cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
- does not identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with anyone with a penis during the previous 12 months
Show all 23Show fewer
- does not identify as White/Caucasian, Black/African American, Latinx, Asian-Pacific Islander, Indigenous, Native American or mixed-race
- does not report living in the Los Angeles metro area
- is non-English speaking
- does not have daily access to an iOS/Android smartphone and/or tablet with internet access
- is a person living with HIV
- for Phase 2 only, participants will be excluded if they participated in the Phase 1B focus groups
- Phase 3:
- is younger than or older than 16- to 26-years
- not cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
- does not identify as gay, bisexual, or some other same-sex identity, and/or does not report having had sex with anyone with a penis during the previous 12 months
- does not identify as White/Caucasian, Black/African American, Hispanic/Latino/Latinx, or mixed-race
- does not report living in the Los Angeles metro area
- is non-English speaking
- is a person living with HIV (self-reported)
- does not report insertive and/or receptive anal sex in the previous 6 months or does not report a positive STI result in the previous 6 months
- does not have daily access to an iOS/Android smartphone and/or tablet with internet access
- is currently on PrEP or has plans to start/restart PrEP in the following 7 days; and 11) is currently enrolled in another HIV prevention study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, Trans and Non-Binary Youth (PrEP2Prevent HIV)
- The goal of this clinical trial entitled, PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, is to develop and test a method for supporting access to an HIV prevention medication called Pre-Exposure Prophylaxis (PrEP) in young men who have sex with men and young transgender and non-binary individuals. The main questions it aims to answer are:
- What are some of the experiences and barriers providers have seen regarding this population accessing PrEP
- Using information gathered from PrEP providers and navigators, develop a mobile health platform and PrEP related content that will be tested by members of the population to see if the features are usable and the content is understandable.
- Enroll 150 study participants to see if utilizing the mobile health platform and receiving supportive sessions related to motivation and barriers to accessing PrEP is achievable.
- Participants will
- Be given access to the mobile health Platform called PrEPresent, which provides them with access to prevention related content, the ability to schedule with a patient navigator and create customizable goals
- Complete a baseline, 3 month and 6 month assessment about personal health, health history and technology, along with a PrEP adherence rapid urine test
- Complete up to 4 sessions to assist participants in the intervention group with discussing any barriers to accessing PrEP
Read the detailed description
The U.S. Department of Health and Human Services (HHS) has set a goal to end the HIV epidemic by the year 2030, which is well within reach given the availability of antiretrovirals that effectively prevent and treat HIV. But success can only be achieved if targeted approaches are implemented with at-risk populations to address known barriers of engagement along the pre-exposure prophylaxis (PrEP) and HIV care continua. In response, obtained funding from NIH, using the R34 mechanism, with the goal of the research being to develop and pilot test a PrEP activation, navigation and support intervention for YMSM, including young Black and Latino YMSM (B-YMSM, L-YMSM), who not only have the highest annual incidence of HIV but who are also the least likely to have ever used PrEP. There is very clear evidence demonstrating that while YMSM have high levels of knowledge about and intentions to use PrEP, few have ever used PrEP. Our own research demonstrate the urgent need for interventions that specifically target PrEP uptake while also addressing a complex array of individual (e.g., side effect concerns, substance use, depression), sociocultural (e.g., internalized homophobia, PrEP-related stigma), and structural (e.g., access to care, medication costs) barriers to PrEP uptake. Our research also demonstrates that such an intervention should include four components: 1) inclusion of PrEP and other service navigation; 2) provision of skills to address patient activation, reduce PrEP-related stigma, and increase PrEP self-efficacy; 3) peer/social support; and 4) utilize a mobile health (mHealth) platform or similar technology that supports both in-person and virtual intervention delivery (text and live video chat). Based on these findings, the investigators propose to conduct research with the following specific aims
Specific Aim 1: Conduct formative research to inform the development of a PrEP activation, navigation and support intervention, which the investigators call PrEP2Prevent. Qualitative data will be collected using structured guides from working/focus groups with YMSM, Trans, and gender non-conforming youth and during Key Informant Interviews (KII) with existing PrEP care providers/navigators. These data will inform intervention content and activation/navigation services.
Specific Aim 2: Develop and then conduct usability testing of PrEP2Prevent, including both the intervention content and mHealth delivery platform. Data from Aim 1 will inform the content and structure of intervention components to be included. During intervention development, two rounds of usability testing will be conducted with 8-10 YMSM, Trans, and gender non-conforming youth to ensure features are usable and the content is understood. Internal beta testing will be performed to assess for full technical functionality.
Specific Aim 3: Evaluate the feasibility, acceptability and preliminary efficacy of PrEP2Prevent with a racially/ethnically diverse sample of 150 (50 Non-Hispanic Whites, 50 Blacks/African American, 50 Latino/Hispanic) YMSM, Trans, gender non-conforming youth, ages 16-26 years. Participants will be randomly assigned in a 1:1 ratio to the intervention app (PrEP2Prevent) or control app (standard of care). Primary outcomes are feasibility, acceptability and preliminary efficacy. Feasibility data will include sources and rates of recruitment/retention, barriers and facilitators to recruitment/retention, engagement with PrEP navigator both in-person and via mHealth platform, as well as paradata on the mHealth platform use (e.g., number of log-ins, time spent, chatroom/text-based discussions). Acceptability will be assessed using a survey with validated measures at intervention completion. Preliminary efficacy will include linkage to PrEP services and PrEP uptake, these data will be collected at baseline and at 3- and 6-months following completion of the intervention. Mediators/moderators will include PrEP self-efficacy, PrEP stigma, and patient activation. The findings from this research will inform further refinements to the intervention and provide estimates of possible intervention effect sizes (group means, SDs) for a future randomized controlled trial (RCT). The funded research is highly significant, timely and innovative. Its innovation lies in the fact that it: a) targets an intervention for YMSM where it is most needed - e.g., on PrEP uptake; b) recognizes that YMSM require tools and support to successfully navigate PrEP services; and c) uses mHealth to deliver the intervention. Moreover, the intervention can be used for both engagement and re-engagement in PrEP uptake for YMSM who cycle in and out of PrEP care. Further, the intervention is potentially easily adaptable and transferable to address other critical PrEP and HIV needs (e.g., uptake of long-acting PrEP and antiretroviral therapy [ART]).
- Conditions
- HIV Infections
- Being tested
- PrEPresent
- Keywords
- PrEP, Mobile Health, LGBTQ, Transgender, Adolescent
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPresentBehavioural
Also called PrEP2Prevent
PrEP2Prevent is being done in several phases (parts) to develop and pilot test a PrEP activation, navigation and support intervention for young men who have sex with men (YMSM), trans youth and non-binary youth in Los Angeles. It targets an intervention for these young people where they need it most - on PrEP uptake. PrEP stands for pre-exposure prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Access to mobile health platform for resources and information about PrEP |
| Experimental | Experimental | Access to mobile health platform for resources and information about PrEP plus sessions with peer health support navigator, social app interactions, goal setting capabilities Receives: Behavioral: PrEPresent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formative Research - PrEP Provider and Navigator Interviews
16 qualitative interviews with PrEP Providers and Navigators will be recorded and transcribed. Using existing theory or prior research, researchers will begin by identifying key concepts or variables as initial coding categories. MAXQDA will provide support in the coding and the ability to better understand and identify emergent themes and conceptual frameworks through network maps. These maps may include: 1) components most relevant for an intervention; 2) effective strategies for activation, motivation and engagement; 3) attitudes and challenges related to PrEP; 4) differences in needs, challenges and expectations across ethnic groups; and/or 5) most relevant/important mHealth features. The maps will then be analyzed to identify the relationships between constructs related to the PrEP cascade and relevant components of an online PrEP navigation model.
Measured: 90 minute one time interview
Formative Research - Youth Working Groups
Two working groups, each with 6-10 racial/ethnically diverse YMSM, Trans, and gender non-conforming youth will be conducted. Working groups will meet weekly (or bi-weekly) for up to four sessions. Participants will be guided in discussions on a variety of topics, including 1) experiences with perceptions of PrEP; 2) understanding how YMSM, Trans, and gender non-conforming youth access care; 3) factors that impact uptake of and use to PrEP; 4) risk perceptions and health as a priority; 5) preferred modality (mobile app, web-based, online chat/video) and frequency of navigation activities; and 6) strategies to increase patient activation self-efficacy, advocacy, motivations). A baseline survey about personal health, health history and technology will be given to participants before their first session. At the end of each session, a satisfaction survey will be given to participants to fill out.
Measured: 4 week duration
Pre-Pilot Mobile App Usability Testing
Recruitment of 8-10 racial/ethnically diverse YMSM, Trans, and gender non-conforming youth. Study participants will participate in one online focus group session to download and review the app, one virtual session with the live PrEP Navigator in either chat or video conference format, and a one-on-one exit interview with a research staff member about their app feedback. Participants will also be asked to fill out Pre-Test and Post-Test survey measures to assess app feedback and general usability. Members of the working groups will be invited to use PreP2Prevent over a 2-week period acting in the role of participants. Beta testing will allow for a full assessment of both the technical functionality of the mHealth platform, and will help finalize pilot test procedures. This will include engaging with the peer navigator in two "mock" navigation sessions (one text-based and one video-based).
Measured: 4 week duration
Patient Navigation Feasibility
Source: Study logs, Post-navigation satisfaction survey Description: # navigation sessions attended/missed, delivery modality (in-person, text, video); # contacts navigator made to schedule each session, # referrals made/attended. Feasibility defined as at least 50% of individuals attending on average >2 sessions over the 3-month intervention period and a mean post-navigation satisfaction survey score of 4 or higher.
Measured: 6 Months
Patient Navigation Acceptability
Source: In-app survey Description: A brief satisfaction assessment (5 questions) will be administered at the end of each navigation session to identify challenges experienced by the participant, the most and least helpful aspects of the session, challenges using the system, satisfaction with information provided, and any additional needs the participant had that the navigator was not able to address.
Measured: 6 Months
PrEP Uptake
Source: Self report Description: PrEP usage quantitative measures at 3 and 6 months
Source: Ursure Description: Point-of-care rapid urine test of tenofovir as a biological marker of recent (within 48 hours) PrEP use
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start28 Jan 2021
- Primary completion20 Jun 2023
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 Control Trial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Florida State University
- Responsible party
- Principal investigator, Michele D. Kipke, Children's Hospital Los Angeles
- Investigators
- Michele D Kipke, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281393
- Sponsor's protocol ID
- CHLA-20-00596
- Acronym
- P2P
- Status last verified
- Feb 2024
- First submitted
- 6 Jan 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers interested in the PrEP2Prevent data can request access to baseline and follow up survey data, specimen collection data and qualitative data from the phase 1 provider interviews in the form of written transcriptions. A publication plan and data use agreement would be reviewed and approved by the PI's prior to sharing any data.
Publications
Calvetti S, Lei B, Stocks JB, Rosso MT, Puentes M, Durazo-Arvizu R, Slay L, Kipke MD, Hightow-Weidman LB. Feasibility and Acceptability of a mHealth Patient Navigation Intervention to Increase Pre-Exposure Prophylaxis Uptake in Racially and Ethnically Diverse Sexual and Gender Minority Youth in Los Angeles (PrEPresent): Pilot Randomized Controlled Trial. JMIR Form Res. 2025 Oct 31;9:e69255. doi: 10.2196/69255.
PubMed 41171997Stocks JB, Calvetti S, Rosso MT, Slay L, Kipke M, Puentes M, Hightow-Weidman LB. Evaluating the Feasibility and Acceptability of a Digital Pre-Exposure Prophylaxis Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth (PrEPresent): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 29;12:e50866. doi: 10.2196/50866.
PubMed 37773616
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, Trans and Non-Binary Youth (PrEP2Prevent HIV)
- ClinicalTrials.gov ID
- NCT05281393
- Acronym / sponsor ID
- P2P / CHLA-20-00596
- Conditions
- HIV Infections
- Keywords
- PrEP, Mobile Health, LGBTQ, Transgender, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Florida State University
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 16 Mar 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 goal of this clinical trial entitled, PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, is to develop and test a method for supporting access to an HIV prevention medication called Pre-Exposure Prophylaxis (PrEP) in young men who have sex with men and young transgender and non-binary individuals. The main questions it aims to answer are:
- What are some of the experiences and barriers providers have seen regarding this population accessing PrEP
- Using information gathered from PrEP providers and navigators, develop a mobile health platform and PrEP related content that will be tested by members of the population to see if the features are usable and the content is understandable.
- Enroll 150 study participants to see if utilizing the mobile health platform and receiving supportive sessions related to motivation and barriers to accessing PrEP is achievable.
- Participants will
- Be given access to the mobile health Platform called PrEPresent, which provides them with access to prevention related content, the ability to schedule with a patient navigator and create customizable goals
- Complete a baseline, 3 month and 6 month assessment about personal health, health history and technology, along with a PrEP adherence rapid urine test
- Complete up to 4 sessions to assist participants in the intervention group with discussing any barriers to accessing PrEP
Detailed description
The U.S. Department of Health and Human Services (HHS) has set a goal to end the HIV epidemic by the year 2030, which is well within reach given the availability of antiretrovirals that effectively prevent and treat HIV. But success can only be achieved if targeted approaches are implemented with at-risk populations to address known barriers of engagement along the pre-exposure prophylaxis (PrEP) and HIV care continua. In response, obtained funding from NIH, using the R34 mechanism, with the goal of the research being to develop and pilot test a PrEP activation, navigation and support intervention for YMSM, including young Black and Latino YMSM (B-YMSM, L-YMSM), who not only have the highest annual incidence of HIV but who are also the least likely to have ever used PrEP. There is very clear evidence demonstrating that while YMSM have high levels of knowledge about and intentions to use PrEP, few have ever used PrEP. Our own research demonstrate the urgent need for interventions that specifically target PrEP uptake while also addressing a complex array of individual (e.g., side effect concerns, substance use, depression), sociocultural (e.g., internalized homophobia, PrEP-related stigma), and structural (e.g., access to care, medication costs) barriers to PrEP uptake. Our research also demonstrates that such an intervention should include four components: 1) inclusion of PrEP and other service navigation; 2) provision of skills to address patient activation, reduce PrEP-related stigma, and increase PrEP self-efficacy; 3) peer/social support; and 4) utilize a mobile health (mHealth) platform or similar technology that supports both in-person and virtual intervention delivery (text and live video chat). Based on these findings, the investigators propose to conduct research with the following specific aims
Specific Aim 1: Conduct formative research to inform the development of a PrEP activation, navigation and support intervention, which the investigators call PrEP2Prevent. Qualitative data will be collected using structured guides from working/focus groups with YMSM, Trans, and gender non-conforming youth and during Key Informant Interviews (KII) with existing PrEP care providers/navigators. These data will inform intervention content and activation/navigation services.
Specific Aim 2: Develop and then conduct usability testing of PrEP2Prevent, including both the intervention content and mHealth delivery platform. Data from Aim 1 will inform the content and structure of intervention components to be included. During intervention development, two rounds of usability testing will be conducted with 8-10 YMSM, Trans, and gender non-conforming youth to ensure features are usable and the content is understood. Internal beta testing will be performed to assess for full technical functionality.
Specific Aim 3: Evaluate the feasibility, acceptability and preliminary efficacy of PrEP2Prevent with a racially/ethnically diverse sample of 150 (50 Non-Hispanic Whites, 50 Blacks/African American, 50 Latino/Hispanic) YMSM, Trans, gender non-conforming youth, ages 16-26 years. Participants will be randomly assigned in a 1:1 ratio to the intervention app (PrEP2Prevent) or control app (standard of care). Primary outcomes are feasibility, acceptability and preliminary efficacy. Feasibility data will include sources and rates of recruitment/retention, barriers and facilitators to recruitment/retention, engagement with PrEP navigator both in-person and via mHealth platform, as well as paradata on the mHealth platform use (e.g., number of log-ins, time spent, chatroom/text-based discussions). Acceptability will be assessed using a survey with validated measures at intervention completion. Preliminary efficacy will include linkage to PrEP services and PrEP uptake, these data will be collected at baseline and at 3- and 6-months following completion of the intervention. Mediators/moderators will include PrEP self-efficacy, PrEP stigma, and patient activation. The findings from this research will inform further refinements to the intervention and provide estimates of possible intervention effect sizes (group means, SDs) for a future randomized controlled trial (RCT). The funded research is highly significant, timely and innovative. Its innovation lies in the fact that it: a) targets an intervention for YMSM where it is most needed - e.g., on PrEP uptake; b) recognizes that YMSM require tools and support to successfully navigate PrEP services; and c) uses mHealth to deliver the intervention. Moreover, the intervention can be used for both engagement and re-engagement in PrEP uptake for YMSM who cycle in and out of PrEP care. Further, the intervention is potentially easily adaptable and transferable to address other critical PrEP and HIV needs (e.g., uptake of long-acting PrEP and antiretroviral therapy [ART]).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Access to mobile health platform for resources and information about PrEP |
| Experimental | Experimental | Behavioral: PrEPresentAccess to mobile health platform for resources and information about PrEP plus sessions with peer health support navigator, social app interactions, goal setting capabilities |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- PrEP providers serving YMSM from healthcare and community-based organizations located in Los Angeles County or PrEP Navigators similarly employed by healthcare and community-based organizations that deliver PrEP services to YMSM.
- >18 years of age
- 16-26 years old
- cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
- identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with anyone with a penis during the previous 12 months
Key exclusion criteria (23 listed)
- Not a PrEP provider or navigator serving YMSM from healthcare and community-based organizations located in Los Angeles County
- under 18 years of age
- is younger than or older than 16- to 26-years
- not cisgender male, Trans, gender non-conforming, or identify differently from the gender picked for you at birth
- does not identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with anyone with a penis during the previous 12 months
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 |
|---|---|---|
| PrEPresentAlso: PrEP2PreventPrEP2Prevent is being done in several phases (parts) to develop and pilot test a PrEP activation, navigation and support intervention for young men who have sex with men (YMSM), trans youth and non-binary youth in Los Angeles. It targets an intervention for these young people where they need it most - on PrEP uptake. PrEP stands for pre-exposure prophylaxis. | Behavioural | Experimental |
Primary outcome
Formative Research - PrEP Provider and Navigator Interviews
Time frame: 90 minute one time interview
16 qualitative interviews with PrEP Providers and Navigators will be recorded and transcribed. Using existing theory or prior research, researchers will begin by identifying key concepts or variables as initial coding categories. MAXQDA will provide support in the coding and the ability to better understand and identify emergent themes and conceptual frameworks through network maps. These maps may include: 1) components most relevant for an intervention; 2) effective strategies for activation, motivation and engagement; 3) attitudes and challenges related to PrEP; 4) differences in needs, challenges and expectations across ethnic groups; and/or 5) most relevant/important mHealth features. The maps will then be analyzed to identify the relationships between constructs related to the PrEP cascade and relevant components of an online PrEP navigation model.
Formative Research - Youth Working Groups
Time frame: 4 week duration
Two working groups, each with 6-10 racial/ethnically diverse YMSM, Trans, and gender non-conforming youth will be conducted. Working groups will meet weekly (or bi-weekly) for up to four sessions. Participants will be guided in discussions on a variety of topics, including 1) experiences with perceptions of PrEP; 2) understanding how YMSM, Trans, and gender non-conforming youth access care; 3) factors that impact uptake of and use to PrEP; 4) risk perceptions and health as a priority; 5) preferred modality (mobile app, web-based, online chat/video) and frequency of navigation activities; and 6) strategies to increase patient activation self-efficacy, advocacy, motivations). A baseline survey about personal health, health history and technology will be given to participants before their first session. At the end of each session, a satisfaction survey will be given to participants to fill out.
Pre-Pilot Mobile App Usability Testing
Time frame: 4 week duration
Recruitment of 8-10 racial/ethnically diverse YMSM, Trans, and gender non-conforming youth. Study participants will participate in one online focus group session to download and review the app, one virtual session with the live PrEP Navigator in either chat or video conference format, and a one-on-one exit interview with a research staff member about their app feedback. Participants will also be asked to fill out Pre-Test and Post-Test survey measures to assess app feedback and general usability. Members of the working groups will be invited to use PreP2Prevent over a 2-week period acting in the role of participants. Beta testing will allow for a full assessment of both the technical functionality of the mHealth platform, and will help finalize pilot test procedures. This will include engaging with the peer navigator in two "mock" navigation sessions (one text-based and one video-based).
Patient Navigation Feasibility
Time frame: 6 Months
Source: Study logs, Post-navigation satisfaction survey Description: # navigation sessions attended/missed, delivery modality (in-person, text, video); # contacts navigator made to schedule each session, # referrals made/attended. Feasibility defined as at least 50% of individuals attending on average >2 sessions over the 3-month intervention period and a mean post-navigation satisfaction survey score of 4 or higher.
Patient Navigation Acceptability
Time frame: 6 Months
Source: In-app survey Description: A brief satisfaction assessment (5 questions) will be administered at the end of each navigation session to identify challenges experienced by the participant, the most and least helpful aspects of the session, challenges using the system, satisfaction with information provided, and any additional needs the participant had that the navigator was not able to address.
PrEP Uptake
Time frame: 6 Months
Source: Self report Description: PrEP usage quantitative measures at 3 and 6 months Source: Ursure Description: Point-of-care rapid urine test of tenofovir as a biological marker of recent (within 48 hours) PrEP use
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 Feb 2024.
- Derived from this study: PubMed 41171997Calvetti S, Lei B, Stocks JB, Rosso MT, Puentes M, Durazo-Arvizu R, Slay L, Kipke MD, Hightow-Weidman LB. Feasibility and Acceptability of a mHealth Patient Navigation Intervention to Increase Pre-Exposure Prophylaxis Uptake in Racially and Ethnically Diverse Sexual and Gender Minority Youth in Los Angeles (PrEPresent): Pilot Randomized Controlled Trial. JMIR Form Res. 2025 Oct 31;9:e69255. doi: 10.2196/69255.
- Derived from this study: PubMed 37773616Stocks JB, Calvetti S, Rosso MT, Slay L, Kipke M, Puentes M, Hightow-Weidman LB. Evaluating the Feasibility and Acceptability of a Digital Pre-Exposure Prophylaxis Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth (PrEPresent): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 29;12:e50866. doi: 10.2196/50866.
- Individual participant dataSharing planned: Yes. Researchers interested in the PrEP2Prevent data can request access to baseline and follow up survey data, specimen collection data and qualitative data from the phase 1 provider interviews in the form of written transcriptions. A publication plan and data use agreement would be reviewed and approved by the PI's prior to sharing any data.
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Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingEarly Phase 1
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
Not yet recruiting
Bwelela Easy Study
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
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.
Michele D Kipke, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEPresent in people with HIV Infections, run by Children's Hospital Los Angeles 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 18 inclusion and 23 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 Feb 2024. 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?
Formative Research - PrEP Provider and Navigator Interviews (time frame: 90 minute one time interview). The study lists 6 primary outcomes in all. 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 NCT05281393, which also lists 2 linked publications.
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 Feb 2024.