A Functional Performance Study of The Wondaleaf Female Condom
Following a pilot function study in 2017, this main function study is a two-period, cross-over randomized trial to determine the functional performance, safety and acceptability of the Wondaleaf female condom in comparison to the FC2 female condom.
The study is enrolling 220 women couples who will use five condoms of each (control and test). Fieldwork commenced in April 2019.
|Funder/Sponsors:||Twin Catalyst, Malaysia|
|Principal Investigator||Dr M Beksinska (MRU)
Dr Ivana Beesham (MRU)
|Site:||Commercial City Site|
ECHO Ancillary Studies
Contraceptive Method Discontinuation
What is reimbursement used for? Participant knowledge and perceptions of appropriate study reimbursement
Pubic hair grooming practices: safety issues, association with STIs and vaginal cleansing.
The Quatro Study: Acceptability study of (placebo) vaginal delivery forms for preventing HIV and unintended pregnancy among young women in Zimbabwe and South Africa
Despite the crucial need, available products to prevent HIV infection and pregnancy, such as male condoms, female condoms, and microbicides, are not under women’s control and are inconsistently used, especially in low resource settings. 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 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.
In addition, data collection activities will be designed to inform development of product educational messages tailored for young women in these Sub-Saharan African settings. The study was conducted in Durban, South Africa and Harare, Zimbabwe and is currently in a dissemination phase.
|Funder/Sponsor:||United States Agency for International Development and The Bill & Melinda Gates Foundation via
CONRAD, Arlington, VA, United States and Women’s Global Health Imperative, RTI International, San Francisco, CA, United States
|Investigators:||WGHI, RTI International
Ariane van der Straten, Elizabeth Montgomery
MatCH Research Unit
Jenni Smit, Mags Beksinska
Z Mike Chirenje, Nyaradzo Mgodi
|Site:||MRU Commercial City Clinic Site|