Clinical trial NCT02602366: The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Contraception
Keywords: HIV
DCE
MPT
Microbicide
Lead sponsor: CONRAD
Sponsor class: OTHER
Collaborators: name: RTI International
name: UZ-UCSF Collaborative Research Programme
name: Match Research
First posted: 2015-11-11
Enrollment: 422
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change from baseline in ratings and relative preference rankings of four vaginal delivery forms
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5
Secondary outcomes:
measure: Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment
timeFrame: Month 5
measure: Adherence assessed by self report via questionnaire
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5
measure: Adherence assessed by objective biomarkers, utilizing antibodies, tagged recombinant proteins, biochemical assays and/or spectroscopy
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: MatCH Research
city: Harare
country: Zimbabwe
facility: The University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF)
Study officials:
affiliation: CONRAD
name: Jill Schwartz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: