NCT02602366

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
OTHER	HEC Placebo Gel
OTHER	Placebo Vaginal Insert
OTHER	Placebo Vaginal Film
OTHER	Placebo Intravaginal ring (IVR)

Timeline

• Start date: 2016-06-06
• Primary completion: 2017-06-30
• Completion: 2017-09-30
• First posted: 2015-11-11
• Last updated: 2018-05-18

Locations

2 sites across 2 countries: South Africa, Zimbabwe