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

2020년 10월 12일 업데이트: New York University
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.

연구 개요

상태

완전한

개입 / 치료

상세 설명

See statistical analysis plan.

연구 유형

관찰

등록 (실제)

2647

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

남성

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Syphilis diagnosis
기간: 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
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
기간: 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
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
기간: 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
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
기간: 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
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
기간: 12 months
Self-reported condom adherence
12 months
Number of ongoing sexual relationships
기간: Through study completion, approximately 2 months
Self-reported number of concurrent sexual partners
Through study completion, approximately 2 months
Number of sexual partners over the past 12 months
기간: 12 months
Self-reported number of sexual partners over the past 12 months
12 months
Selecting a potential date with many recent partners
기간: 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

Through study completion, approximately 2 months
Selecting a potential date with frequent recreational drug use
기간: 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

Through study completion, approximately 2 months
Selecting a potential date with occasional condom adherence
기간: 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

Through study completion, approximately 2 months

기타 결과 측정

결과 측정
측정값 설명
기간
The likelihood at which a respondent would engage a partner in casual sex with without using condoms
기간: Through study completion, approximately 2 months
This is collected as a follow-up question for each profile in the conjoint experiment as detailed above
Through study completion, approximately 2 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Kinga R Makovi, PhD, New York University Abu Dhabi

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 1월 20일

기본 완료 (실제)

2020년 3월 15일

연구 완료 (실제)

2020년 3월 15일

연구 등록 날짜

최초 제출

2020년 2월 29일

QC 기준을 충족하는 최초 제출

2020년 3월 26일

처음 게시됨 (실제)

2020년 3월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 10월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 10월 12일

마지막으로 확인됨

2020년 10월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다