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

Sexually Transmitted Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325555
• Other study ID #: 097-2018
• Status: Completed
• Start date: January 20, 2020
• Est. completion date: March 15, 2020

Study information

• Verified date: October 2020
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

See statistical analysis plan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2647
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea
• Sexually Transmitted Diseases
• Syphilis

Intervention

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.

Locations

Country	Name	City	State
United Arab Emirates	New York University Abu Dhabi	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Percent of time that condoms were used in sexual intercourse	Self-reported condom adherence	12 months
Primary	Number of ongoing sexual relationships	Self-reported number of concurrent sexual partners	Through study completion, approximately 2 months
Primary	Number of sexual partners over the past 12 months	Self-reported number of sexual partners over the past 12 months	12 months
Primary	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
Primary	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
Primary	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