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

Sponsor
New York University (Other)
Overall Status
Completed
CT.gov ID
NCT04325555
Collaborator
(none)
2,647
1
1.8
1464.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

See statistical analysis plan.

Study Design

Study Type:
Observational
Actual Enrollment :
2647 participants
Observational Model:
Case-Crossover
Time Perspective:
Retrospective
Official Title:
Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Mar 15, 2020
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Syphilis diagnosis [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]

    Self-reported diagnosis of syphilis

  2. Chlamydia diagnosis [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]

    Self-reported diagnosis of chlamydia

  3. Gonorrhea diagnosis [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]

    Self-reported diagnosis of gonorrhea

  4. Sexually transmitted diseases [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]

    Self-reported diagnosis of any STD

  5. Percent of time that condoms were used in sexual intercourse [12 months]

    Self-reported condom adherence

  6. Number of ongoing sexual relationships [Through study completion, approximately 2 months]

    Self-reported number of concurrent sexual partners

  7. Number of sexual partners over the past 12 months [12 months]

    Self-reported number of sexual partners over the past 12 months

  8. Selecting a potential date with many recent partners [Through study completion, approximately 2 months]

    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

  9. Selecting a potential date with frequent recreational drug use [Through study completion, approximately 2 months]

    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

  10. Selecting a potential date with occasional condom adherence [Through study completion, approximately 2 months]

    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

Other Outcome Measures

  1. The likelihood at which a respondent would engage a partner in casual sex with without using condoms [Through study completion, approximately 2 months]

    This is collected as a follow-up question for each profile in the conjoint experiment as detailed above

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York University Abu Dhabi Abu Dhabi United Arab Emirates 00000

Sponsors and Collaborators

  • New York University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
New York University
ClinicalTrials.gov Identifier:
NCT04325555
Other Study ID Numbers:
  • 097-2018
First Posted:
Mar 27, 2020
Last Update Posted:
Oct 14, 2020
Last Verified:
Oct 1, 2020
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2020