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

Study Overview
=================
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.

Official 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

Conditions
-----------------
HIV, Contraception

Intervention / Treatment
-----------------
* Other: HEC Placebo Gel
* Other: Placebo Vaginal Insert
* Other: Placebo Vaginal Film
* Other: Placebo Intravaginal ring (IVR)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Month 1<br>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 Gel<br> <br> Other: Placebo Vaginal Insert<br> <br> Other: Placebo Vaginal Film<br> <br> Other: Placebo Intravaginal ring (IVR)<br> <br> |
| Other: Month 2<br>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 Gel<br> <br> Other: Placebo Vaginal Insert<br> <br> Other: Placebo Vaginal Film<br> <br> Other: Placebo Intravaginal ring (IVR)<br> <br> |
| Other: Month 3<br>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 Gel<br> <br> Other: Placebo Vaginal Insert<br> <br> Other: Placebo Vaginal Film<br> <br> Other: Placebo Intravaginal ring (IVR)<br> <br> |
| Other: Month 4<br>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 Gel<br> <br> Other: Placebo Vaginal Insert<br> <br> Other: Placebo Vaginal Film<br> <br> Other: Placebo Intravaginal ring (IVR)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, DCE, MPT, Microbicide