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Clinical Trials/NCT04325555
NCT04325555
Completed
Not Applicable

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

New York University1 site in 1 country2,647 target enrollmentJanuary 20, 2020

Overview

Phase
Not Applicable
Intervention
PrEP
Conditions
Syphilis
Sponsor
New York University
Enrollment
2647
Locations
1
Primary Endpoint
Chlamydia diagnosis
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

See statistical analysis plan.

Registry
clinicaltrials.gov
Start Date
January 20, 2020
End Date
March 15, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: PrEP

Outcomes

Primary Outcomes

Chlamydia diagnosis

Time Frame: 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

Gonorrhea diagnosis

Time Frame: 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

Syphilis diagnosis

Time Frame: 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

Sexually transmitted diseases

Time Frame: 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

Percent of time that condoms were used in sexual intercourse

Time Frame: 12 months

Self-reported condom adherence

Number of ongoing sexual relationships

Time Frame: Through study completion, approximately 2 months

Self-reported number of concurrent sexual partners

Number of sexual partners over the past 12 months

Time Frame: 12 months

Self-reported number of sexual partners over the past 12 months

Selecting a potential date with many recent partners

Time Frame: 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

Selecting a potential date with frequent recreational drug use

Time Frame: 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

Selecting a potential date with occasional condom adherence

Time Frame: 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

Study Sites (1)

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