Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 9, 2015
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date May 18, 2018
Actual Study Start Date  ICMJE June 6, 2016
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment [ Time Frame: Month 5 ]
  • Adherence assessed by self report via questionnaire [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy
Official Title  ICMJE The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy Among Young Women in Zimbabwe and South Africa
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • HIV
  • Contraception
Intervention  ICMJE
  • Other: HEC Placebo Gel
  • Other: Placebo Vaginal Insert
  • Other: Placebo Vaginal Film
  • Other: Placebo Intravaginal ring (IVR)
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Other: HEC Placebo Gel
    • Other: Placebo Vaginal Insert
    • Other: Placebo Vaginal Film
    • Other: Placebo Intravaginal ring (IVR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2018)
422
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
400
Actual Study Completion Date  ICMJE September 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   Zimbabwe
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02602366
Other Study ID Numbers  ICMJE Quatro
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CONRAD
Study Sponsor  ICMJE CONRAD
Collaborators  ICMJE
  • RTI International
  • UZ-UCSF Collaborative Research Programme
  • Match Research
Investigators  ICMJE
Principal Investigator: Jill Schwartz, MD, MPH CONRAD
PRS Account CONRAD
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP