NCT02602366

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable hiv

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

June 6, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

November 9, 2015

Last Update Submit

May 15, 2018

Conditions

HIVContraception

Keywords

HIVDCEMPTMicrobicide

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in ratings and relative preference rankings of four vaginal delivery forms

    Baseline, Month 1, Month 2, Month 3, Month 4, Month 5

Secondary Outcomes (3)

  • Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment

    Month 5

  • Adherence assessed by self report via questionnaire

    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

    Baseline, Month 1, Month 2, Month 3, Month 4, Month 5

Study Arms (4)

Month 1

OTHER

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 GelOther: Placebo Vaginal InsertOther: Placebo Vaginal FilmOther: Placebo Intravaginal ring (IVR)

Month 2

OTHER

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 GelOther: Placebo Vaginal InsertOther: Placebo Vaginal FilmOther: Placebo Intravaginal ring (IVR)

Month 3

OTHER

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 GelOther: Placebo Vaginal InsertOther: Placebo Vaginal FilmOther: Placebo Intravaginal ring (IVR)

Month 4

OTHER

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 GelOther: Placebo Vaginal InsertOther: Placebo Vaginal FilmOther: Placebo Intravaginal ring (IVR)

Interventions

HEC Placebo GelOTHER
Month 1Month 2Month 3Month 4
Placebo Vaginal InsertOTHER
Month 1Month 2Month 3Month 4
Placebo Vaginal FilmOTHER
Month 1Month 2Month 3Month 4
Placebo Intravaginal ring (IVR)OTHER
Month 1Month 2Month 3Month 4

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MatCH Research

Durban, South Africa

Location

The University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF)

Harare, Zimbabwe

Location

Study Officials

  • Jill Schwartz, MD, MPH

    CONRAD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 11, 2015

Study Start

June 6, 2016

Primary Completion

June 30, 2017

Study Completion

September 30, 2017

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

ZA(1)ZI(1)