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

NCT04325555 | Completed

• 1 other identifier: 097-2018
• Study Type: observational
• Target: 2,647
• Locations: 1 country
• Sites: 1

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.

Conditions

Syphilis; Chlamydia; Gonorrhea; Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• The likelihood at which a respondent would engage a partner in casual sex with without using condoms

  Through study completion, approximately 2 months

Study Arms (1)

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.

Drug: PrEP

Interventions

PrEP DRUG

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.

Respondents on PrEP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

New York University Abu Dhabi

Abu Dhabi, 00000, United Arab Emirates

Location

MeSH Terms

Conditions

Syphilis; Chlamydia Infections; Gonorrhea; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections; Neisseriaceae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kinga R Makovi, PhD

  New York University Abu Dhabi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 27, 2020
• Study Start: January 20, 2020
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

AE (1)