The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy
NCT ID: NCT02602366
Last Updated: 2018-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
422 participants
INTERVENTIONAL
2016-06-06
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Month 1
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
HEC Placebo Gel
Placebo Vaginal Insert
Placebo Vaginal Film
Placebo Intravaginal ring (IVR)
Month 2
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
HEC Placebo Gel
Placebo Vaginal Insert
Placebo Vaginal Film
Placebo Intravaginal ring (IVR)
Month 3
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
HEC Placebo Gel
Placebo Vaginal Insert
Placebo Vaginal Film
Placebo Intravaginal ring (IVR)
Month 4
In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design.
HEC Placebo Gel
Placebo Vaginal Insert
Placebo Vaginal Film
Placebo Intravaginal ring (IVR)
Interventions
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HEC Placebo Gel
Placebo Vaginal Insert
Placebo Vaginal Film
Placebo Intravaginal ring (IVR)
Eligibility Criteria
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Inclusion Criteria
* In good health, as determined by the site Investigator or designee based on clinical history
* Willing and able to comply with study procedures and attend monthly follow-up visits
* Willing and able to provide informed consent
* Fluent in one of the languages being used in the study (English, Shona or Zulu)
* Not intending to travel or move out of the research catchment area for the next 6 months
* Sexually active defined by vaginal intercourse with a male at least 4 times per month in the past 3 months and plan to be sexually active during the study duration
Exclusion Criteria
* Pregnant, or intention to become pregnant during the clinical study
* Prior participation in any HIV-prevention or MPT product demonstration study or clinical trial
* Any current or historical health (including vaginal or genitourinary conditions) or psychological issues that the site Investigator or his/her designee determines should exclude the potential participant
18 Years
30 Years
FEMALE
Yes
Sponsors
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RTI International
OTHER
UZ-UCSF Collaborative Research Programme
OTHER
Match Research
OTHER
CONRAD
OTHER
Responsible Party
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Principal Investigators
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Jill Schwartz, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
CONRAD
Locations
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MatCH Research
Durban, , South Africa
The University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF)
Harare, , Zimbabwe
Countries
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Other Identifiers
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Quatro
Identifier Type: -
Identifier Source: org_study_id
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