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Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy

15 juni 2026 uppdaterad av: HIV Prevention Trials Network

Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men

Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study will test a suite of mHealth tools to increase HIV pre-exposure prophylaxis (PrEP) uptake and adherence among young men in communities most affected by the HIV epidemic and evaluate the uptake, adherence, and acceptability of doxycycline for sexually transmitted infection (STI) post-exposure prophylaxis (doxy-PEP).

Studietyp

Interventionell

Inskrivning (Beräknad)

400

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Kailazarid Gomez-Feliciano, MPM
  • Telefonnummer: 919-321-3486
  • E-post: kgomez@fhi360.org

Studieorter

  • Argentina
      • Buenos Aires, Argentina, C1427CEA
  • Brasilien
    • Rio de Janeiro
      • Manguinhos, Rio de Janeiro, Brasilien, 221045-900
        • Instituto de Pesquisa Clinicaq Evandro Chagas CRS
  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90095
    • New York
      • The Bronx, New York, Förenta staterna, 10451
        • Bronx Prevention Research Center CRS
        • Kontakt:
  • Peru
      • Lima, Peru, 32-15088

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria:

  1. Men ages 18 - 29 years
  2. Men who are in communities most affected by the HIV epidemic
  3. Willing and able to provide informed consent
  4. Reports having anal sex with men in the last 6 months

  5. Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:

    1. Any condomless anal sex with a man; not including within a monogamous relationship with an HIV-negative partner or an HIV-positive partner who is virally suppressed
    2. Reporting 2 or more male partners, regardless of condom use
    3. Reporting gonorrhea, chlamydia, or syphilis diagnosis
    4. Any stimulant use (e.g., cocaine, amphetamines)
  6. Not on PrEP within the past 3 months due to participant choice
  7. Interested in learning more about PrEP or starting PrEP
  8. No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm
  9. Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages
  10. Must not share the mobile phone used for their participation in the study
  11. Able to read and write

Exclusion Criteria:

  1. Participated in HPTN 113-01
  2. Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083
  3. Plans to move away from the study area within the next year
  4. Currently on doxycycline for STI PEP
  5. Has ever used CAB-LA or other long-acting PrEP agent
  6. Tetracycline allergy
  7. Prior diagnosis of HIV infection
  8. Reactive HIV rapid test at Screening or reactive HIV Ag/Ab rapid test at Enrollment, regardless of subsequent HIV test results
  9. Any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 3P mHealth package
HIV PrEP, doxy-PEP, 3P mHealth package (3P: MyPrEP + PrEPmate + PrEPsmart tools) to assist with PrEP uptake and adherence decision making, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site
Läkemedel: HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA
Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
Läkemedel: STI PEP - Doxycycline as Doxy-PEP
Doxycycline as doxy-PEP for STI prevention
Beteende: 3P mHealth package
Suite of mHealth tools (MyPrEP, PrEPmate, PrEPsmart) to assist with HIV PrEP uptake and adherence decision making
Beteende: Handout about HIV PrEP options available at the site
Handout about HIV PrEP options available at the site
Beteende: Standard-of-care HIV PrEP counseling from qualified study staff
Standard-of-care HIV PrEP counseling from qualified study staff
Aktiv komparator: Standard-of-care services
HIV PrEP, doxy-PEP, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site
Läkemedel: HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA
Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
Läkemedel: STI PEP - Doxycycline as Doxy-PEP
Doxycycline as doxy-PEP for STI prevention
Beteende: Handout about HIV PrEP options available at the site
Handout about HIV PrEP options available at the site
Beteende: Standard-of-care HIV PrEP counseling from qualified study staff
Standard-of-care HIV PrEP counseling from qualified study staff

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To determine the efficacy of the 3P mHealth package on PrEP uptake among participants
Tidsram: 52 weeks
PrEP uptake is defined as the proportion of enrolled participants who elect to initiate PrEP (with a documented PrEP dispensation by the site) at any time during the 52 weeks of follow-up. Participants who did not initiate PrEP before loss to follow-up will be classified as non-initiators. PrEP uptake will be assessed at Week 52 for each study arm with 95% confidence limits computed using the binomial distribution. A logistic regression model will be used to compare PrEP uptake between the study arms.
52 weeks
To determine the efficacy of the 3P mHealth package on PrEP adherence among participants
Tidsram: Weeks 20, 36, and 52

PrEP adherence is assessed at Weeks 20, 36 and 52 through biomedical testing for oral PrEP regimens and documentation of CAB-LA injection for CAB-LA.

Adherence measures are described in Section 8.7. Participants on oral PrEP missing an assessment visit and with no PrEP dispensed at their most recent visit will be considered non-adherent. Also, participants who have not yet initiated PrEP at a visit will be considered non-adherent at that visit. The average PrEP adherence at a visit will be computed as the proportion of participants who are determined to be adherent at that visit by study arm. The associated 95% confidence limits will be computed using the binomial distribution. Generalized estimating equations (GEE) with a logit link function will be used to examine differences in adherence proportions between the 3P and Control arms at Weeks 20, 36 and 52, while accounting for potential correlation between PrEP adherence measures over time for each participant.
Weeks 20, 36, and 52
To assess doxycycline PEP uptake and associated factors
Tidsram: Week 52
doxy-PEP uptake is defined as the proportion of participants dispensed doxy-PEP during the 52 weeks of study follow-up period. doxy-PEP uptake will be computed with 95% confidence limits at Week 52. Multivariable logistic regression models will be used to assess association between doxy-PEP uptake and factors including study group, demographic and behavioral characteristics.
Week 52
To assess doxycycline PEP use and associated factors
Tidsram: Weeks 20, 36, and 52
doxy-PEP use will be assessed at Weeks 20, 36 and 52. Doxy-PEP use at an assessment visit will be computed as the proportion of participants reporting use following sex acts, reported at that visit. The corresponding 95% confidence limits will be computed based on the binomial distribution. Multivariable GEE models will be used to investigate possible associations between doxy-PEP use and factors including study group, demographic and behavioral characteristics.
Weeks 20, 36, and 52
To assess doxycycline PEP acceptability and associated factors
Tidsram: Week 52
Descriptive statistics will be used to summarize doxy-PEP acceptability. Multivariable generalized linear models (with a link function that is appropriate to the scale of the measure for doxy-PEP acceptability) will be used to investigate associations between doxy-PEP acceptability and factors including study group, sociodemographic, and behavioral characteristics.
Week 52
To assess the incidence of HIV infections among participants choosing to use CAB-LA
Tidsram: Week 52

Uptake of CAB-LA is defined as the proportion of participants choosing to initiate CAB-LA with a documented receipt of a CAB-LA injection during the study follow-up period. CAB-LA uptake will be computed with 95% confidence interval.

Incidence of HIV infection between the date of CAB-LA initiation and the date of switch to oral PrEP (for participants switching from CAB-LA to oral PrEP) or end of follow-up (for participants staying on CAB-LA from initiation through the end of the follow-up period) will be computed with 95% confidence interval among participants choosing to use CAB-LA.
Week 52

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To determine the acceptability and use of the 3P mHealth package in the intervention arm by site
Tidsram: Week 52
Descriptive statistics will be used to summarize the acceptability and use of the 3P mHealth package in the intervention arm by site.
Week 52
To compare the frequency, directionality, and reasons for PrEP regimen choice and switching, between arms
Tidsram: Week 52
Descriptive statistics will be used to summarize the frequency, directionality, and reasons for PrEP regimen choice and switching by arm. Generalized linear models will be used to assess differences in these descriptive summaries between the study arms. Reasons for PrEP regimen choice and switching obtained from qualitative interview data will be listed by arm.
Week 52
To evaluate demographic, behavioral, and attitudinal factors associated with choice of PrEP regimen
Tidsram: Week 52
Multivariable logistic regression models will be used to separately assess associations between each PrEP regimen choice and demographic, behavioral, and attitudinal factors.
Week 52
To determine the efficacy of the 3P mHealth package on prevention-effective adherence
Tidsram: Weeks 20, 36, and 52
  • The proportion of enrolled participants with incident STI infection will be computed with 95% confidence limits at Weeks 20, 36 and 52 by study arm.
  • The proportion of enrolled participants with incident HIV infection will be computed at Weeks 20, 36 and 52 by study arm.
  • The proportion of enrolled participants reporting HIV risk based on self-reported sexual behavior and HIV status of sexual partner will be computed at Weeks 20, 36 and 52 by study arm.
  • The proportion of enrolled participants who are determined to be PrEP adherent and potentially at HIV risk (based on incident STI, self-reported sexual behavior and HIV status of partners) will be computed with 95% confidence limits at Weeks 20, 36 and 52 by study arm. GEE models with a logit link function will be used to compare the proportions between the study arms
Weeks 20, 36, and 52

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

HIV Prevention Trials Network

Samarbetspartners

National Institute of Allergy and Infectious Diseases (NIAID)
Gilead Sciences
ViiV Healthcare

Utredare

  • Studiestol: Susan Buchbinder, MD, San Francisco Department of Public Health and University of California San Francisco
  • Studiestol: Jorge Gallardo-Cartagena, MD, Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales
  • Studiestol: Thiago Torres, MD, Instituto Nacional de Infectologia Evandro Chagas

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2029

Avslutad studie (Beräknad)

1 september 2029

Studieregistreringsdatum

Först inskickad

7 oktober 2024

Först inskickad som uppfyllde QC-kriterierna

15 juni 2026

Första postat (Faktisk)

22 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HPTN 113
  • UM1AI068619 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

For studies within two years of primary objective(s) publication, de-identified individual participant data that underlie results in a publication, will be provided upon request. For studies more than two years from the primary objective(s) publication, de-identified datasets will be available upon request (Public Use Datasets).

Tidsram för IPD-delning

Investigators may request de-identified datasets in order to duplicate published results, as required by specific journals. Otherwise, de-identified datasets will be made available upon request, two years following publication of the primary results manuscript.

Kriterier för IPD Sharing Access

Researchers may submit a request for access to data that has informed published results, by sending an email to HPTN-Data-Access@scharp.org. To access available de-identified datasets, investigators must complete the request form on the Atlas website. Researchers of approved requests will need to sign an HIV Prevention Trials Network (HPTN) Data Use Agreement before receiving the data and agree to use the provided acknowledgement statement.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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