Evidence map›Paper›PMID 39804696›Full record

Trial reportJournal of medical Internet research2025

Studying the Digital Intervention Engagement-Mediated Relationship Between Intrapersonal Measures and Pre-Exposure Prophylaxis Adherence in Sexual and Gender Minority Youth: Secondary Analysis of a Randomized Controlled Trial.

Michael P Williams, Justin Manjourides, Louisa H Smith, Crissi B Rainer, Lisa B Hightow-Weidman, Danielle F Haley

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03320512 (P3), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03320512 nacompletednot on this map

P3 (Prepared, Protected, emPowered): Promoting Pre-exposure Prophylaxis (PrEP) Adherence Through a Social Networking, Gamification, and Adherence Support App

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2019 to 2021Enrolled246ConditionsSexually Transmitted Diseases, Safe Sex, Adherence, MedicationArmsP3, P3+, Control
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Michael P WilliamsBouve College of Health Sciences, Northeastern University, Boston, MA, United States.ORCID 0000-0002-3121-2204
Justin ManjouridesBouve College of Health Sciences, Northeastern University, Boston, MA, United States.ORCID 0000-0002-2454-4489
Louisa H SmithRoux Institute, Northeastern University, Portland, ME, United States.ORCID 0000-0001-9029-4644
Crissi B RainerCollege of Nursing, Florida State University, Tallahassee, FL, United States.ORCID 0009-0007-1312-7325
Lisa B Hightow-WeidmanCollege of Nursing, Florida State University, Tallahassee, FL, United States.ORCID 0000-0002-2421-923X
Danielle F HaleyDepartment of Community Health Sciences, Boston University, Boston, MA, United States.ORCID 0000-0002-4281-2731

Funding

Bridging the Science-to-Service Gap in Aging Care: Prevention, Optimization and Living Well with Persistent or Serious IllnessesT32AG081327 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI Christine S Ritchie, Ana-Maria Vranceanu · 2023 to 2026
$1.6M
Quantifying health policy impacts on substance use and treatment among women with and at risk for HIV: a longitudinal multilevel analysis using the Women's Interagency HIV StudyK01DA046307 · NIDA · NORTHEASTERN UNIVERSITY · PI HALEY, DANIELLE FRANCES · 2018 to 2022
$865k
Neighborhood and digital immersion effects on PrEP adherence through a digital intervention in young sexual and gender minorities who have sex with menF31HD108046 · NICHD · NORTHEASTERN UNIVERSITY · PI WILLIAMS, MICHAEL PATRICK · 2022 to 2024
$103k
NIA NIH HHS T32 AG081327NICHD NIH HHS F31 HD108046NIDA NIH HHS K01 DA046307
6 · The paper itself

Abstract

backgroundImproving adherence to pre-exposure prophylaxis (PrEP) via digital health interventions (DHIs) for young sexual and gender minority men who have sex with men (YSGMMSM) is promising for reducing the HIV burden. Measuring and achieving effective engagement (sufficient to solicit PrEP adherence) in YSGMMSM is challenging.

objectiveThis study is a secondary analysis of the primary efficacy randomized controlled trial (RCT) of Prepared, Protected, Empowered (P3), a digital PrEP adherence intervention that used causal mediation to quantify whether and to what extent intrapersonal behavioral, mental health, and sociodemographic measures were related to effective engagement for PrEP adherence in YSGMMSM.

methodsIn May 2019, 264 YSGMMSM were recruited for the primary RCT via social media, community sites, and clinics from 9 study sites across the United States. For this secondary analysis, 140 participants were eligible (retained at follow-up, received DHI condition in primary RCT, and completed trial data). Participants earned US currency for daily use of P3 and lost US currency for nonuse. Dollars accrued at the 3-month follow-up were used to measure engagement. PrEP nonadherence was defined as blood serum concentrations of tenofovir-diphosphate and emtricitabine-triphosphate that correlated with ≤4 doses weekly at the 3-month follow-up. Logistic regression was used to estimate the total effect of baseline intrapersonal measures on PrEP nonadherence, represented as odds ratios (ORs) with a null value of 1. The total OR for each intrapersonal measure was decomposed into direct and indirect effects.

resultsFor every US $1 earned above the mean (US $96, SD US $35.1), participants had 2% (OR 0.98, 95% CI 0.97-0.99) lower odds of PrEP nonadherence. Frequently using phone apps to track health information was associated with a 71% (OR 0.29, 95% CI 0.06-0.96) lower odds of PrEP nonadherence. This was overwhelmingly a direct effect, not mediated by engagement, with a percentage mediated (PM) of 1%. Non-Hispanic White participants had 83% lower odds of PrEP nonadherence (OR 0.17, 95% CI 0.05-0.48) and had a direct effect (PM=4%). Participants with depressive symptoms and anxiety symptoms had 3.4 (OR 3.42, 95% CI 0.95-12) and 3.5 (OR 3.51, 95% CI 1.06-11.55) times higher odds of PrEP nonadherence, respectively. Anxious symptoms largely operated through P3 engagement (PM=51%).

conclusionsP3 engagement (dollars accrued) was strongly related to lower odds of PrEP nonadherence. Intrapersonal measures operating through P3 engagement (indirect effect, eg, anxious symptoms) suggest possible pathways to improve PrEP adherence DHI efficacy in YSGMMSM via effective engagement. Conversely, the direct effects observed in this study may reflect existing structural disparity (eg, race and ethnicity) or behavioral dispositions toward technology (eg, tracking health via phone apps). Evaluating effective engagement in DHIs with causal mediation approaches provides a clarifying and mechanistic view of how DHIs impact health behavior.

trial registrationClinicalTrials.gov; NCT03320512; https://clinicaltrials.gov/study/NCT03320512.

Indexed as

HIV InfectionsMedication AdherencePre-Exposure ProphylaxisSexual and Gender MinoritiesAdolescentAdultAnti-HIV AgentsFemaleHomosexuality, MaleHumansMaleUnited StatesYoung AdultAnti-HIV Agentsadherenceadolescentdigital health interventionengagementgender minorityhealth behaviorhealth informationHIVlogistic regressionmental healthmen who have sex with menpre-exposure prophylaxisPrEPrandomized controlled trialsexual healthsexual orientationsociodemographicteenageryouth

Identifiers

PMID39804696
PMCPMC11773288

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.