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

CONRAD

Status: Completed

Conditions: Contraception; HIV

Treatments: Other: Placebo Vaginal Insert; Other: Placebo Vaginal Film; Other: HEC Placebo Gel; Other: Placebo Intravaginal ring (IVR)

Study type: Interventional

Funder types: Other

Identifiers

NCT02602366

Quatro

Details and patient eligibility

About

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.

Enrollment: 422 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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422 participants in 4 patient groups

Month 1

Other group

Description:

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.

Treatment:

Other: Placebo Vaginal Film

Other: Placebo Intravaginal ring (IVR)

Other: HEC Placebo Gel

Other: Placebo Vaginal Insert

Month 2

Other group

Description:

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.

Treatment:

Other: Placebo Vaginal Film

Other: Placebo Intravaginal ring (IVR)

Other: HEC Placebo Gel

Other: Placebo Vaginal Insert

Month 3

Other group

Description:

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.

Treatment:

Other: Placebo Vaginal Film

Other: Placebo Intravaginal ring (IVR)

Other: HEC Placebo Gel

Other: Placebo Vaginal Insert

Month 4

Other group

Description:

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.

Treatment:

Other: Placebo Vaginal Film

Other: Placebo Intravaginal ring (IVR)

Other: HEC Placebo Gel

Other: Placebo Vaginal Insert