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The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy

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ClinicalTrials.gov Identifier: NCT02602366
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
RTI International
UZ-UCSF Collaborative Research Programme
Match Research
Information provided by (Responsible Party):
CONRAD

Study Description
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Brief Summary:
The purpose of The Quatro Study is to assess the acceptability, preferences, user experience and effect on sexual behavior of four different vaginal microbicide or multi-purpose technology (MPT) delivery forms, using placebo products in 18-30 year old African women: rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. The study also examines adherence to the dosage forms through objective markers, developed for each dosage form prior to the commencement of the study.

Condition or disease Intervention/treatment Phase
HIV Contraception Other: HEC Placebo Gel Other: Placebo Vaginal Insert Other: Placebo Vaginal Film Other: Placebo Intravaginal ring (IVR) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy Among Young Women in Zimbabwe and South Africa
Actual Study Start Date : June 6, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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.
 Other: HEC Placebo Gel
Other: Placebo Vaginal Insert
Other: Placebo Vaginal Film
Other: 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.
 Other: HEC Placebo Gel
Other: Placebo Vaginal Insert
Other: Placebo Vaginal Film
Other: 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.
 Other: HEC Placebo Gel
Other: Placebo Vaginal Insert
Other: Placebo Vaginal Film
Other: 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.
 Other: HEC Placebo Gel
Other: Placebo Vaginal Insert
Other: Placebo Vaginal Film
Other: Placebo Intravaginal ring (IVR)


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in ratings and relative preference rankings of four vaginal delivery forms [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5 ]

Secondary Outcome Measures :
  1. Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment [ Time Frame: Month 5 ]
  2. Adherence assessed by self report via questionnaire [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5 ]
  3. Adherence assessed by objective biomarkers, utilizing antibodies, tagged recombinant proteins, biochemical assays and/or spectroscopy [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-30
  • 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:

  • HIV positive
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602366


Locations
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South Africa
MatCH Research
Durban, South Africa
Zimbabwe
The University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF)
Harare, Zimbabwe
Sponsors and Collaborators
CONRAD
RTI International
UZ-UCSF Collaborative Research Programme
Match Research
Investigators
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Principal Investigator: Jill Schwartz, MD, MPH CONRAD
More Information
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Responsible Party: CONRAD
ClinicalTrials.gov Identifier: NCT02602366    
Other Study ID Numbers: Quatro
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Keywords provided by CONRAD:
HIV
DCE
MPT
Microbicide