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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602366
• Other study ID #: Quatro
• Status: Completed
• Phase: N/A
• Start date: June 6, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: May 2018
• Source: CONRAD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: September 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• HIV

Intervention

Other:
• HEC Placebo Gel

• Placebo Vaginal Insert

• Placebo Vaginal Film

• Placebo Intravaginal ring (IVR)

Locations

Country	Name	City	State
South Africa	MatCH Research	Durban
Zimbabwe	The University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF)	Harare

Sponsors (4)

Lead Sponsor	Collaborator
CONRAD	Match Research, RTI International, UZ-UCSF Collaborative Research Programme

Countries where clinical trial is conducted

South Africa,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment		Month 5
Secondary	Adherence assessed by self report via questionnaire		Baseline, Month 1, Month 2, Month 3, Month 4, Month 5
Secondary	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