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Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard

maanantai 12. lokakuuta 2020 päivittänyt: New York University
The investigators study the behavioral consequences of Pre-exposure Prophylaxis or PrEP on sexual health behaviors, sexual health outcomes, and partner selection preferences. The study collects observational, self-reported data on PrEP status, PrEP taking-history, PrEP adherence over the last 30 days, STD diagnosis history dating back to January 2015 up to December 2019, sexual health behaviors (e.g., positioning, number of lifetime/recent partners, condom adherence etc.), and various demographic characteristics. The survey finishes with a conjoint experiment which asks respondents to select between two potential partners, and follow-up question about each profiles. Potential partners' characteristics include recreational drug use and condom adherence. Recruitment is conducted via running an ad on Facebook in New York, London, Toronto and Sydney for comparative purposes, as these metro areas have varying levels of PrEP use and accessibility.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

See statistical analysis plan.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

2647

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Uros

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

The survey is being distributed via Facebook ads, which are geographically targeted in the above-mentioned metro areas, with filters set up to target specifically males who are likely to be men who have sex with men (MSM). This latter is achieved by setting up a long list of sites that have been liked or followed, which map onto sexual orientation. The survey is incentivized with an Amazon gift card to be given to a randomly selected participant in each of the geographic areas after completion. Those who click on the ad are directed to the survey. They first receive questions that gauges their eligibility, and in case they are not eligible, they are screened out of the survey, and are not eligible to enroll in the raffle for the gift card, which is only available for those who finished the sutdy.

Kuvaus

Inclusion Criteria:

  • 18 years or above
  • living in the London, New York, Toronto or Sydney metro area
  • self-reported sex at birth is male
  • reported ever having sex with a male

Exclusion Criteria:

  • not meeting the inclusion criteria

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
Respondents on PrEP

On PrEP status will be operationalized in multiple ways, and sensitivity analyses will be conducted using multiple definitions as a result of the self-reported nature of the study.

  1. Respondents "on PrEP" are respondents who reported that they are currently on PrEP
  2. Respondents "on PrEP" are respondents who reported to have ever been on PrEP
  3. When respondents are used as their own controls, years on PrEP will be those in which they reported to have been on PrEP for at lest 6 months, and PrEP initiation will be the first such year

A comparison group will be constructed by matching on a variety of characteristics, when this method is applied. Most importantly, age, and STD testing frequency among others, which influence the likelihood of being on PrEP and via that avenue sexual practices, as well as the likelihood of detecting STDs (i.e., ascertainment bias). In other models adjustments will be made for these factors.
Lääke: PrEP
The investigators measure self-reported PrEP status as exposure, i.e., PrEP status is not confirmed via matched medical records or any other type of information directly collected form subjects.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Syphilis diagnosis
Aikaikkuna: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
Self-reported diagnosis of syphilis
All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
Chlamydia diagnosis
Aikaikkuna: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
Self-reported diagnosis of chlamydia
All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
Gonorrhea diagnosis
Aikaikkuna: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
Self-reported diagnosis of gonorrhea
All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
Sexually transmitted diseases
Aikaikkuna: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
Self-reported diagnosis of any STD
All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
Percent of time that condoms were used in sexual intercourse
Aikaikkuna: 12 months
Self-reported condom adherence
12 months
Number of ongoing sexual relationships
Aikaikkuna: Through study completion, approximately 2 months
Self-reported number of concurrent sexual partners
Through study completion, approximately 2 months
Number of sexual partners over the past 12 months
Aikaikkuna: 12 months
Self-reported number of sexual partners over the past 12 months
12 months
Selecting a potential date with many recent partners
Aikaikkuna: Through study completion, approximately 2 months

The likelihood of selecting a potential date with 6 or more recent sexual partners in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan.

As part of a conjoint experiment the investigators expose participants to a partner selection task.

The attributes in the experiment and possible attribute values can be seen below:

Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent
Through study completion, approximately 2 months
Selecting a potential date with frequent recreational drug use
Aikaikkuna: Through study completion, approximately 2 months

The likelihood of selecting a potential date with frequent recreational drug use in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan.

As part of a conjoint experiment the investigators expose participants to a partner selection task.

The attributes in the experiment and possible attribute values can be seen below:

Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent
Through study completion, approximately 2 months
Selecting a potential date with occasional condom adherence
Aikaikkuna: Through study completion, approximately 2 months

The likelihood of selecting a potential date with occasional condom use in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan.

As part of a conjoint experiment the investigators expose participants to a partner selection task.

The attributes in the experiment and possible attribute values can be seen below:

Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent
Through study completion, approximately 2 months

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
The likelihood at which a respondent would engage a partner in casual sex with without using condoms
Aikaikkuna: Through study completion, approximately 2 months
This is collected as a follow-up question for each profile in the conjoint experiment as detailed above
Through study completion, approximately 2 months

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

New York University

Tutkijat

  • Päätutkija: Kinga R Makovi, PhD, New York University Abu Dhabi

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 20. tammikuuta 2020

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 15. maaliskuuta 2020

Opintojen valmistuminen (Todellinen)

Sunnuntai 15. maaliskuuta 2020

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Lauantai 29. helmikuuta 2020

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 26. maaliskuuta 2020

Ensimmäinen Lähetetty (Todellinen)

Perjantai 27. maaliskuuta 2020

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 14. lokakuuta 2020

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 12. lokakuuta 2020

Viimeksi vahvistettu

Torstai 1. lokakuuta 2020

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 097-2018

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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