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

May 15, 2018 updated by: CONRAD

The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy Among Young Women in Zimbabwe and South Africa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

422

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Durban, South Africa
        • MatCH Research
  • Zimbabwe
      • Harare, Zimbabwe
        • The University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Film
Other: Placebo Vaginal Insert
Other: Placebo Intravaginal ring (IVR)
Other: 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 Film
Other: Placebo Vaginal Insert
Other: Placebo Intravaginal ring (IVR)
Other: 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 Film
Other: Placebo Vaginal Insert
Other: Placebo Intravaginal ring (IVR)
Other: 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 Film
Other: Placebo Vaginal Insert
Other: Placebo Intravaginal ring (IVR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Month 1, Month 2, Month 3, Month 4, Month 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment
Time Frame: Month 5
Month 5
Adherence assessed by self report via questionnaire
Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5
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
Baseline, Month 1, Month 2, Month 3, Month 4, Month 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CONRAD

Collaborators

RTI International
Match Research
UZ-UCSF Collaborative Research Programme

Investigators

  • Principal Investigator: Jill Schwartz, MD, MPH, CONRAD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Quatro

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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