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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02602366
• Date of registration: 09/11/2015
• Prospective Registration: Yes
• Primary sponsor: CONRAD
• Public title: The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy
• Scientific 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
• Date of first enrolment: June 6, 2016
• Target sample size: 422
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02602366
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

South Africa, Zimbabwe

Contacts

• Name: Jill Schwartz, MD, MPH
• Affiliation: CONRAD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 30 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Contraception

HIV

Intervention(s)

Other: Placebo Vaginal Insert

Other: Placebo Vaginal Film

Other: HEC Placebo Gel

Other: Placebo Intravaginal ring (IVR)

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

Quatro

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

RTI International

UZ-UCSF Collaborative Research Programme

Match Research