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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04325555
Enrollment
2647
Registered
2020-03-27
Start date
2020-01-20
Completion date
2020-03-15
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia, Gonorrhea, Sexually Transmitted Diseases, Syphilis

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.

Interventions

DRUGPrEP

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.

Sponsors

New York University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Selecting a potential date with occasional condom adherenceThrough study completion, approximately 2 monthsThe 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
Syphilis diagnosisAll 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/daySelf-reported diagnosis of syphilis
Chlamydia diagnosisAll 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/daySelf-reported diagnosis of chlamydia
Gonorrhea diagnosisAll 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/daySelf-reported diagnosis of gonorrhea
Sexually transmitted diseasesAll 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/daySelf-reported diagnosis of any STD
Percent of time that condoms were used in sexual intercourse12 monthsSelf-reported condom adherence
Number of ongoing sexual relationshipsThrough study completion, approximately 2 monthsSelf-reported number of concurrent sexual partners
Number of sexual partners over the past 12 months12 monthsSelf-reported number of sexual partners over the past 12 months
Selecting a potential date with many recent partnersThrough study completion, approximately 2 monthsThe 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 useThrough study completion, approximately 2 monthsThe 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

Other

MeasureTime frameDescription
The likelihood at which a respondent would engage a partner in casual sex with without using condomsThrough study completion, approximately 2 monthsThis is collected as a follow-up question for each profile in the conjoint experiment as detailed above

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026