Contraception, HIV
Conditions
Keywords
HIV, DCE, MPT, Microbicide
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.
Interventions
Sponsors
RTI International
UZ-UCSF Collaborative Research Programme
Match Research
CONRAD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
South Africa, Zimbabwe
Outcome results
None listed