HIVNCT02602366
The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy
A study of HIV and Contraception, run by CONRAD at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Contraception
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jun 2016to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Zimbabwe1 site
The University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF)
Harare
About this 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
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.
- Conditions
- HIV, Contraception
- Being tested
- HEC Placebo Gel, Placebo Vaginal Insert, Placebo Vaginal Film, Placebo Intravaginal ring (IVR)
- Keywords
- HIV, DCE, MPT, Microbicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC Placebo GelOther
Placebo Vaginal InsertOther
Placebo Vaginal FilmOther
Placebo Intravaginal ring (IVR)Other
| Study group | Role | What they receive |
|---|---|---|
| Month 1 | Other | 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. Receives: Other: HEC Placebo Gel; Other: Placebo Vaginal Insert; Other: Placebo Vaginal Film; Other: Placebo Intravaginal ring (IVR) |
| Month 2 | Other | 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. Receives: Other: HEC Placebo Gel; Other: Placebo Vaginal Insert; Other: Placebo Vaginal Film; Other: Placebo Intravaginal ring (IVR) |
| Month 3 | Other | 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. Receives: Other: HEC Placebo Gel; Other: Placebo Vaginal Insert; Other: Placebo Vaginal Film; Other: Placebo Intravaginal ring (IVR) |
| Month 4 | Other | 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. Receives: Other: HEC Placebo Gel; Other: Placebo Vaginal Insert; Other: Placebo Vaginal Film; Other: Placebo Intravaginal ring (IVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ratings and relative preference rankings of four vaginal delivery forms
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5
Secondary outcomes (3)
Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment
Measured: Month 5
Adherence assessed by self report via questionnaire
Measured: 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
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start6 Jun 2016
- Primary completion30 Jun 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International, UZ-UCSF Collaborative Research Programme, Match Research
- Responsible party
- Sponsor
- Investigators
- Jill Schwartz, MD, MPH, Principal investigator, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602366
- Sponsor's protocol ID
- Quatro
- Status last verified
- May 2018
- First submitted
- 9 Nov 2015
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02602366
- Acronym / sponsor ID
- Quatro
- Conditions
- HIV, Contraception
- Keywords
- HIV, DCE, MPT, Microbicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Collaborators
- RTI International, UZ-UCSF Collaborative Research Programme, Match Research
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Month 1 | Other | Other: HEC Placebo Gel, Other: Placebo Vaginal Insert, Other: Placebo Vaginal Film, Other: Placebo Intravaginal ring (IVR)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. |
| Month 2 | Other | Other: HEC Placebo Gel, Other: Placebo Vaginal Insert, Other: Placebo Vaginal Film, Other: Placebo Intravaginal ring (IVR)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. |
| Month 3 | Other | Other: HEC Placebo Gel, Other: Placebo Vaginal Insert, Other: Placebo Vaginal Film, Other: Placebo Intravaginal ring (IVR)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. |
| Month 4 | Other | Other: HEC Placebo Gel, Other: Placebo Vaginal Insert, Other: Placebo Vaginal Film, Other: Placebo Intravaginal ring (IVR)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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC Placebo Gel | Other | Month 1, Month 2, Month 3, Month 4 |
| Placebo Vaginal Insert | Other | Month 1, Month 2, Month 3, Month 4 |
| Placebo Vaginal Film | Other | Month 1, Month 2, Month 3, Month 4 |
| Placebo Intravaginal ring (IVR) | Other | Month 1, Month 2, Month 3, Month 4 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Schwartz, MD, MPH principal investigator
CONRAD
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of HIV and Contraception, run by CONRAD at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.