- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04325555
Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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-
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Abu Dhabi, Förenade arabemiraten, 00000
- New York University Abu Dhabi
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Syphilis diagnosis
Tidsram: 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
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Self-reported diagnosis of syphilis
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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
Tidsram: 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
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Self-reported diagnosis of chlamydia
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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
Tidsram: 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
Tidsram: 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
Tidsram: 12 months
|
Self-reported condom adherence
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12 months
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Number of ongoing sexual relationships
Tidsram: Through study completion, approximately 2 months
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Self-reported number of concurrent sexual partners
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Through study completion, approximately 2 months
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Number of sexual partners over the past 12 months
Tidsram: 12 months
|
Self-reported number of sexual partners over the past 12 months
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12 months
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Selecting a potential date with many recent partners
Tidsram: 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
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Selecting a potential date with frequent recreational drug use
Tidsram: 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
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Selecting a potential date with occasional condom adherence
Tidsram: 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
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The likelihood at which a respondent would engage a partner in casual sex with without using condoms
Tidsram: Through study completion, approximately 2 months
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This is collected as a follow-up question for each profile in the conjoint experiment as detailed above
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Through study completion, approximately 2 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kinga R Makovi, PhD, New York University Abu Dhabi
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Infektioner
- Smittsamma sjukdomar
- Sjukdomsegenskaper
- Gram-negativa bakteriella infektioner
- Bakteriella infektioner
- Bakteriella infektioner och mykoser
- Neisseriaceae-infektioner
- Sexuellt överförbara sjukdomar, bakteriella
- Spirochaetales infektioner
- Treponemal infektioner
- Gonorré
- Sexuellt överförbara sjukdomar
- Syfilis
Andra studie-ID-nummer
- 097-2018
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