PROJECT SUMMARY
Young persons, aged 13-24 years, accounted for 21% of new infections in the United States in 2018, and 81%
of these occurred in young gay, bisexual, and other men who have sex with men (YGBMSM). Currently, there
are 4 different regimens of pre-exposure prophylaxis (PrEP) available for YGBMSM: 1) daily tenofovir
disoproxil fumarate co-formulated with emtricitabine (TDF/FTC), 2) daily tenofovir alafenamide co-formulated
with emtricitabine (TAF/FTC), 3) peri-coital TDF/FTC (“2-1-1 PrEP”), and 4) injectable long-acting cabotegravir.
PrEP Choice is a package of three mobile health tools designed to increase the uptake and adherence to PrEP
for YGBMSM, aged 13-24 years, to be tested in multiple sites in the United States. PrEP Choice consists of 1)
MyPrEP, a website to help YGBMSM choose the type of PrEP that works best for them; 2) PrEPmate, a two-
way SMS texting tool to check in with YGBMSM on a weekly basis and troubleshoot any problems with PrEP
that arise; and 3) PrEPsmart, an app that reminds PrEP users taking PrEP pills when their next pill should be
taken. These tools have been developed and tested individually; this is the first study to test the package of
these tools to see if they increase the proportion of YGBMSM who take PrEP, and their adherence to PrEP
once they start. The study begins by ensuring that PrEP Choice is relevant for both Spanish- and English-
speaking YGBMSM across the country, through the use of focus groups, followed by a technical pilot in 20
YGBMSM, to work out any bugs in the system and to help determine how best to apply PrEP Choice in this
population. Then, 200 YGBMSM not currently on PrEP will be recruited into a trial in which 100 are randomly
chosen to get PrEP Choice, and the other 100 are randomly chosen to get a brochure describing the different
types of PrEP available. After 9 months of follow-up, PrEP starts and use over time will be compared between
the two groups. Then, the 100 participants initially given the brochure only will get access to the PrEP Choice
package, and both groups will be followed for another 9 months to study their use of PrEP over time. PrEP use
will be measured by testing for tenofovir diphosphate (TFV-DP) levels in dried blood spots (for the 3 types of
PrEP that use pills) or the number of PrEP injections they get (for injectable long acting cabotegravir.) The
primary outcome is PrEP use at 9 months into the study, and this study will enroll enough participants to be
able to tell whether there is at least a 20% increase in the proportion of YGBMSM who use any PrEP in the
PrEP Choice group compared with the brochure group, and a 22.5% increase in PrEP adherence (as
measured by TFV-DP levels or administration of long-acting cabotegravir) in the PrEP Choice group compared
with the brochure group. The cost and cost-effectiveness of the PrEP Choice package will also be assessed for
YGBMSM. The trial will be conducted through the Adolescent Trials Network for HIV/AIDS Interventions (ATN),
making use of their biostatistical and modeling resources, geographic and site diversity, and multidisciplinary
expertise, including young advisors from the target population.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AIDS preventionAccountingAddressAdherenceAdolescentAdolescent Medicine Trials NetworkAdoptionAgeBiometryBisexualBloodCaliforniaCaringCellular PhoneCollectionCommunicationConflict (Psychology)Cost MeasuresCountryCrossover DesignDiphosphatesDoseDrynessEffectiveness of InterventionsEnrollmentEnsureEthnic OriginEventEvidence based interventionFDA approvedFeedbackFocus GroupsFumaratesGaysGeographyHIVHIV InfectionsHIV diagnosisHIV/AIDSIndividualInfectionInjectableInjectionsInterventionLeadershipLinkMeasuresMediatorModalityModelingModificationOralPamphletsParticipantPatientsPerformancePersonsPharmaceutical PreparationsPilot ProjectsPopulationPopulation HeterogeneityRaceRandomizedRandomized, Controlled TrialsRegimenResourcesSelf EfficacySiteSouthern AfricaSpanishSpanish/EnglishSpottingsSystemTarget PopulationsTenofovirTestingText MessagingTimeUnited StatesWaiting ListsWorkYouthagedarmcostcost effectivecost effectivenesscost estimatecost-effectiveness ratiodesigneffectiveness evaluationefficacy evaluationempowermentemtricitabineevidence basefollow-upimprovedincremental cost-effectivenessinnovationintervention costmHealthmen who have sex with menmobile applicationmobile computingmultidisciplinarypillpre-exposure prophylaxispreferenceprimary outcomeprovider communicationrecruitsupport toolstooltwo way textinguptakeusabilityweb siteyoung adultyoung woman
Eunice Kennedy Shriver National Institute of Child Health and Human Development
CFDA Code
DUNS Number
790877419
UEI
JF2BLNN4PJC3
EXTRKMMCVKS7
WEUJG9RND395
Project Start Date
25-January-2023
Project End Date
21-March-2025
Budget Start Date
01-December-2024
Budget End Date
30-November-2025
Project Funding Information for 2025
Total Funding
$429,460
Direct Costs
$429,460
Indirect Costs
Year
Funding IC
FY Total Cost by IC
2025
Eunice Kennedy Shriver National Institute of Child Health and Human Development
$429,460
Year
Funding IC
FY Total Cost by IC
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