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

NCT02602366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2018-05-18

No results posted yet for this study

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.

Conditions

  • HIV
  • Contraception

Interventions

OTHER

HEC Placebo Gel

OTHER

Placebo Vaginal Insert

OTHER

Placebo Vaginal Film

OTHER

Placebo Intravaginal ring (IVR)

Sponsors & Collaborators

  • RTI International

    collaborator OTHER

  • UZ-UCSF Collaborative Research Programme

    collaborator OTHER

  • Match Research

    collaborator OTHER

  • CONRAD

    lead OTHER

Principal Investigators

  • Jill Schwartz, MD, MPH · CONRAD

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-06
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • South Africa
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02602366 on ClinicalTrials.gov