The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy
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ClinicalTrials.gov Identifier: NCT02602366 |
Recruitment Status :
Completed
First Posted : November 11, 2015
Last Update Posted : May 18, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Contraception | Other: HEC Placebo Gel Other: Placebo Vaginal Insert Other: Placebo Vaginal Film Other: Placebo Intravaginal ring (IVR) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 422 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | June 6, 2016 |
Actual Primary Completion Date : | June 30, 2017 |
Actual Study Completion Date : | September 30, 2017 |

Arm | Intervention/treatment |
---|---|
Month 1
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.
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Other: HEC Placebo Gel Other: Placebo Vaginal Insert Other: Placebo Vaginal Film Other: Placebo Intravaginal ring (IVR) |
Month 2
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 Other: Placebo Vaginal Insert Other: Placebo Vaginal Film Other: Placebo Intravaginal ring (IVR) |
Month 3
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 Other: Placebo Vaginal Insert Other: Placebo Vaginal Film Other: Placebo Intravaginal ring (IVR) |
Month 4
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 Other: Placebo Vaginal Insert Other: Placebo Vaginal Film Other: Placebo Intravaginal ring (IVR) |
- Change from baseline in ratings and relative preference rankings of four vaginal delivery forms [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5 ]
- Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment [ Time Frame: Month 5 ]
- Adherence assessed by self report via questionnaire [ Time Frame: 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 [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5 ]

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Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602366
South Africa | |
MatCH Research | |
Durban, South Africa | |
Zimbabwe | |
The University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF) | |
Harare, Zimbabwe |
Principal Investigator: | Jill Schwartz, MD, MPH | CONRAD |
Responsible Party: | CONRAD |
ClinicalTrials.gov Identifier: | NCT02602366 |
Other Study ID Numbers: |
Quatro |
First Posted: | November 11, 2015 Key Record Dates |
Last Update Posted: | May 18, 2018 |
Last Verified: | May 2018 |
HIV DCE MPT Microbicide |