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

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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; Chlamydia; Gonorrhea; Syphilis
• Intervention / Treatment: Drug: PrEP

Detailed Description

See statistical analysis plan.

• Study Type: Observational
• Enrollment (Actual): 2647

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 00000
    • New York University Abu Dhabi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.; Respondents "on PrEP" are respondents who reported that they are currently on PrEP; Respondents "on PrEP" are respondents who reported to have ever been on PrEP; 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.

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Syphilis diagnosis	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	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	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	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	Self-reported condom adherence	12 months
Number of ongoing sexual relationships	Self-reported number of concurrent sexual partners	Through study completion, approximately 2 months
Number of sexual partners over the past 12 months	Self-reported number of sexual partners over the past 12 months	12 months
Selecting a potential date with many recent partners	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	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The likelihood at which a respondent would engage a partner in casual sex with without using condoms	This is collected as a follow-up question for each profile in the conjoint experiment as detailed above	Through study completion, approximately 2 months

Collaborators and Investigators

• Sponsor: New York University
• Investigators: Principal Investigator: Kinga R Makovi, PhD, New York University Abu Dhabi

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: February 29, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Treponemal Infections; Gonorrhea; Sexually Transmitted Diseases; Syphilis
• Other Study ID Numbers: 097-2018