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Completed

NCT Number: NCT02602366

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

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.

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Key information

Conditions

HIV Contraception

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MatCH Research, Durban, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEC Placebo Gel

Other

Placebo Vaginal Insert

Other

Placebo Vaginal Film

Other

Placebo Intravaginal ring (IVR)

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CONRAD

Other

Collaborators

  • Match Research
  • RTI International
  • UZ-UCSF Collaborative Research Programme

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2015
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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