Clinical trial NCT04325555: Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard
Official title: Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syphilis
Chlamydia
Gonorrhea
Sexually Transmitted Diseases
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 2647
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Syphilis diagnosis
timeFrame: 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
measure: Chlamydia diagnosis
timeFrame: 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
measure: Gonorrhea diagnosis
timeFrame: 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
measure: Sexually transmitted diseases
timeFrame: 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
measure: Percent of time that condoms were used in sexual intercourse
timeFrame: 12 months
measure: Number of ongoing sexual relationships
timeFrame: Through study completion, approximately 2 months
measure: Number of sexual partners over the past 12 months
timeFrame: 12 months
measure: Selecting a potential date with many recent partners
timeFrame: Through study completion, approximately 2 months
measure: Selecting a potential date with frequent recreational drug use
timeFrame: Through study completion, approximately 2 months
measure: Selecting a potential date with occasional condom adherence
timeFrame: Through study completion, approximately 2 months
Secondary outcomes:
Other outcomes:
measure: The likelihood at which a respondent would engage a partner in casual sex with without using condoms
timeFrame: Through study completion, approximately 2 months
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: New York University Abu Dhabi
Study officials:
affiliation: New York University Abu Dhabi
name: Kinga R Makovi, PhD
role: PRINCIPAL_INVESTIGATOR
References: