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

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.

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