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

12. oktober 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

See statistical analysis plan.

Studietype

Observasjonsmessig

Registrering (Faktiske)

2647

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Syphilis diagnosis
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 months
Self-reported condom adherence
12 months
Number of ongoing sexual relationships
Tidsramme: 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
Tidsramme: 12 months
Self-reported number of sexual partners over the past 12 months
12 months
Selecting a potential date with many recent partners
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The likelihood at which a respondent would engage a partner in casual sex with without using condoms
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

New York University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. januar 2020

Primær fullføring (Faktiske)

15. mars 2020

Studiet fullført (Faktiske)

15. mars 2020

Datoer for studieregistrering

Først innsendt

29. februar 2020

Først innsendt som oppfylte QC-kriteriene

26. mars 2020

Først lagt ut (Faktiske)

27. mars 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 097-2018

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