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Completed

NCT Number: NCT04325555

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

New York University Abu Dhabi

Abu Dhabi, 00000, United Arab Emirates

About this study

See statistical analysis plan.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Syphilis diagnosis

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 12 months

    Self-reported condom adherence

  6. Number of ongoing sexual relationships

    Time frame: Through study completion, approximately 2 months

    Self-reported number of concurrent sexual partners

  7. Number of sexual partners over the past 12 months

    Time frame: 12 months

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

  8. Selecting a potential date with many recent partners

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

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

    Time frame: Through study completion, approximately 2 months

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

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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