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

12 octobre 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

See statistical analysis plan.

Type d'étude

Observationnel

Inscription (Réel)

2647

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Homme

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Syphilis diagnosis
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 12 months
Self-reported condom adherence
12 months
Number of ongoing sexual relationships
Délai: 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
Délai: 12 months
Self-reported number of sexual partners over the past 12 months
12 months
Selecting a potential date with many recent partners
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
The likelihood at which a respondent would engage a partner in casual sex with without using condoms
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

New York University

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 janvier 2020

Achèvement primaire (Réel)

15 mars 2020

Achèvement de l'étude (Réel)

15 mars 2020

Dates d'inscription aux études

Première soumission

29 février 2020

Première soumission répondant aux critères de contrôle qualité

26 mars 2020

Première publication (Réel)

27 mars 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 octobre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 octobre 2020

Dernière vérification

1 octobre 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 097-2018

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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