HIV, HIV Prevention, STIs, STIs Prevention
Conditions
Keywords
HIV, STIs, sexually transmitted infection, PrEP, DoxyPEP, mobile health, mHealth
Brief summary
The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people. It is hypothesized that PrEP Choice will improve HIV PrEP uptake and adherence among young people and will be cost-effective to deliver to young people in the United States (U.S.). This study will also assess the uptake, adherence, and acceptability of DoxyPEP among young people.
Detailed description
This is an individual-level randomized trial with a wait-list control and provides PrEP and DoxyPEP for study participants at the Adolescent Medicine Trials Network for HIV Interventions (ATN) Site Consortiums (SCs). This study will be conducted to determine the efficacy and cost of the PrEP Choice package on initiation and long-term adherence (persistence) of PrEP use over 18 months among young people (n=200). All participants will receive brief, basic counseling about the different PrEP methods and a PrEP handout from the participating SC. They will also receive counseling and a handout about DoxyPEP. Participants in the intervention arm will receive the PrEP Choice package starting at enrollment. Participants in the control arm will receive the PrEP Choice package starting at 9 months after enrollment. Both intervention and control groups will be followed for a total of 18 months. All PrEP drugs will be dispensed by the participating SCs. Participants can select from the following PrEP agents and regimens: (1) daily oral tenofovir/emtricitabine (tenofovir disoproxil fumarate \[TDF\]/emtricitabine \[FTC\]; (2) daily oral tenofovir alafenamide (TAF)/FTC; (3) 2-1-1 event-driven oral TDF/FTC; (4) bimonthly long-acting injectable cabotegravir (CAB-LA); or (5) twice yearly long-acting injectable lenacapavir (LEN). Participants can opt to start PrEP or change regimens at any time in the 18 months of follow-up. At 9 months, participants originally randomized to the control condition will begin to receive the PrEP Choice package in a wait-list control design. This addresses ethical concerns about withholding a potentially effective intervention from the control arm for an extended period. This design also allows for comparison both between arms (intervention versus control), as well as within arms (before versus after the PrEP Choice package in control arm) and allows measurement of extended outcomes and switching patterns for those initially randomized to the PrEP Choice package over 18 months. In addition, DoxyPEP will be offered to both study arms throughout the study.
Interventions
OTHERStandard of care and PrEP Choice at Enrollment
Standard of care includes a handout describing the different PrEP regimens as well as a handout describing DoxyPEP. PrEP Choice is a package of three mHealth tools: 1. MyPrEP, a decision support website to help PrEP users choose their optimal PrEP method; 2. PrEPsmart, a mobile app to support PrEP adherence for persons using on-demand PrEP (2-1-1 oral PrEP) by providing dosing reminders and feedback on levels of protection; and PrEPmate, a bidirectional short message service (SMS) texting platform with automated daily reminders for oral PrEP users and a triage function to help those experiencing difficulties.
OTHERStandard of care followed by PrEP Choice at Month 9
Standard of care includes a handout describing the different PrEP regimens as well as a handout describing DoxyPEP. PrEP Choice is a package of three mHealth tools: 1. MyPrEP, a decision support website to help PrEP users choose their optimal PrEP method; 2. PrEPsmart, a mobile app to support PrEP adherence for persons using on-demand PrEP (2-1-1 oral PrEP) by providing dosing reminders and feedback on levels of protection; and PrEPmate, a bidirectional short message service (SMS) texting platform with automated daily reminders for oral PrEP users and a triage function to help those experiencing difficulties.
Sponsors
Westat
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
Florida State University
The Emmes Company, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants randomized to the intervention arm will be onboarded at enrollment to PrEP Choice and continue to use the tools through the end of the 18-month follow up. Participants randomized to the control arm will be onboarded at 9 months post-enrollment to PrEP Choice in a waitlist control design and continue to use the tools through the end of the 18-months follow-up.
Eligibility
Sex/Gender
MALE
Age
13 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 13-24 years, inclusive; * Self-reports being at increased likelihood for HIV acquisition, defined as having anal sex with a male in their lifetime; * Owns an iOS or Android Smartphone and able to access all elements of the PrEP Choice package; * Not currently on PrEP and interested in learning more about PrEP; * Is not living with HIV; * Weighs at least 35 kg; * Willing to receive PrEP care from a provider at a participating ATN SC; * Able to understand, read, and speak English; * Able to participate at the study site; and * Willing and able to provide written informed consent. * If of legal age or otherwise able to provide independent informed consent as determined by local law and consistent with IRB policies: Willing and able to provide written informed consent for study participation. * If not of legal age or otherwise not able to provide independent informed consent as determined by local law and consistent with IRB policies: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation.
Exclusion criteria
* Female; * In a mutually monogamous sexual relationship with a partner not living with HIV for the past 12 months; * Currently participating in an interventional trial of PrEP agents, or prior enrollment in HPTN 083, HPTN 083-01, or any other study of long-acting PrEP (including PURPOSE- 2 lenacapavir study); * Plan to move within 18 months to an area inaccessible to a participating ATN SC; * An employee of the participating SC; or * Any concurrent participation in other clinical trials or behavioral intervention studies without prior approval from the protocol team. * Any other medical, behavioral, or other conditions that in the opinion of the SC Project Lead could interfere with adherence to study procedures or the individual's ability to remain in the study for an 18-month period or compromise interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Uptake; proportion of participants receiving PrEP from the study site within 9 months of study follow-up | first 9 months of follow up | 1\. PrEP uptake; the proportion of participants receiving PrEP from the study site within 9 months of study follow-up. PrEP uptake is binary, indicating whether the study participant has received PrEP from the study site. This endpoint compares the proportion of participants who receive PrEP from the study site within the first 9 months of study follow-up between the treatment arms. |
| PrEP Adherence; rate at which participants who received PrEP on study adhere to selected PrEP regimen as measured by dried blood spot for oral regimen and by the on-time CAB-LA and LEN injections for injectable PrEP | first 9 months of follow-up | 1\. PrEP adherence, the rate at which participants who received PrEP on study adhere to the selected PrEP regimen as measured by dried blood spot for participants selecting an oral regimen and by the on-time CAB-LA and LEN injections for participants opting for injectable PrEP through the first 9 months of study follow-up. PrEP adherence, as measured by dried blood stop for participants selecting an oral regimen and by the on-time CAB-LA and LEN injections for participants option for injectable PrEP, will be assessed every 3 months, and the rate at 9 months of study follow-up will be compared between arms. |
| DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site | 18 months of follow up | 1\. DoxyPEP uptake, the rate at which participants receive DoxyPEP from the study site within 18 months of study follow-up. DoxyPEP uptake is binary, indicating whether the study participant has received DoxyPEP from the study site. This endpoint compares the rates of participants who receive DoxyPEP from the study site, assessed every 3 months through the 18 months of study follow-up, between treatment conditions. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months. |
| DoxyPEP Adherence; the rate at which participants are adherent to DoxyPEP coverage of condomless sexual exposures as measured by self-report | 18 months of follow up | 1\. DoxyPEP adherence, the rate at which participants are adherent to DoxyPEP coverage of condomless sexual exposures as measured by self-report. DoxyPEP adherence is binary, indicated whether the study participant used DoxyPEP to cover their last condomless sexual exposure. This endpoint will be assessed every 3 months through 18 months of study follow-up and compared between treatment conditions. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months. |
| DoxyPEP Acceptability; assessed by Likert scale every 3 months of study follow-up | 18 months of follow up | DoxyPEP acceptability, assessed by Likert scale every 3 months of study follow-up through 18 months of follow-up. DoxyPEP acceptability Likert scale results will be compared between the treatment conditions, assessed every 3 months through 18 months of study follow-up. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months. The Likert Scale is as follows: 1. Very acceptable 2. Somewhat acceptable 3. Neither acceptable nor unacceptable 4. Somewhat unacceptable 5. Very unacceptable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP modality choice and switching | 18 months of follow up | PrEP modality choice and switching, the proportion of participants who choose each PrEP regimen initially, the proportion of participants within each regimen who switch to another regimen, and the proportion of participants who choose each PrEP regimen with their second choice, among those who switch initial PrEP regimens through 18 months of study follow-up. |
| PrEP Adherence; rate at which participants who received PrEP on study adhere to selected PrEP regimen as measured by dried blood spot for oral regimen and by the on-time CAB-LA and LEN injections for injectable PrEP | 18 months of follow up | 7\. PrEP adherence, the rate at which participants who received PrEP on study adhere to the selected PrEP regimen as measured by dried blood spot for participants selecting an oral PrEP regimen and by the on-time CAB-LA and LEN injections for participants opting for injectable PrEP through the 18 months of study follow-up. PrEP adherence, as measured by dried blood spot for participants selecting an oral regimen and by the on-time CAB-LA and LEN injections for participants opting for injectable PrEP, will be assessed every 3 months, and the rate at 18 months of study follow-up will be compared between treatment conditions. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months. |
| STI Incidence; individual and combined rates of gonorrhea, chlamydia, and/or early syphilis infection compared between DoxyPEP users and non-users, assessed every 3 months | 18 months of follow-up | STI incidence, individual and combined rates of gonorrhea, chlamydia, and/or early syphilis infection compared between DoxyPEP users and non-users, assessed every 3 months through 18 months of study follow-up. STIs will be assessed by STI testing at the site every 3 months through 18 months of study follow-up. Combined STI incidence is defined as having at least 1 STI at a study visit. Rates of STI will be compared between users of DoxyPEP and non-users through 18 months of study follow-up. Participants will be classified as a user or non-user at each study assessment based on their self-reported use since the last assessment. |
| DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site | First 9 months of follow-up | 9\. DoxyPEP uptake, the rate at which participants receive DoxyPEP from the study site within 9 months of study follow-up. DoxyPEP uptake is binary, indicated whether the study participant has received DoxyPEP from the study site. This endpoint compares the rates of participants who receive DoxyPEP from the study site, assessed every 3 months, through the first 9 months of study follow-up, between treatment arms. |
Countries
United States
Contacts
CONTACTErin Healey
CONTACTNancy Liu
STUDY_CHAIRSusan Buchbinder
San Francisco Department of Public Health
STUDY_CHAIRAlbert Liu
San Francisco Department of Public Health
PRINCIPAL_INVESTIGATORLisa Hightow-Weidman, MD, MPH
Florida State University
PRINCIPAL_INVESTIGATORSybil Hosek, PhD
University of Illinois at Chicago
Outcome results
None listed