Contraception
Conditions
Keywords
AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, HB sAg Hepatitis B surface antigen, ICH International Conference of Harmonization, IND Investigational New Drug Application, IRB Institutional Review Board, IU International units, mg milligram(s), mm3 cubic millimeter(s), PCR polymerase chain reaction, SAE serious adverse event, µg microgram, ULN upper limit of the normal range, WB Western Blot
Brief summary
Evaluation of preference for three female condoms (FC).
Detailed description
The primary goal of this study was to identify the female condom most preferred by study participants. This provided USAID with data to make informed decisions regarding female condom purchases. The study was conducted in three parts. The objective of Part 1 was to familiarize each participant with the three FC types, to minimize learning curve effect in subsequent phases of study, and to gather information on participant demographics, FC acceptability, device function, safety, preference for each of the condom types, and use of male condoms during the same time period. The objective of Part 2 was to determine actual, unstated and unbiased preference for a particular type of FC. The objective of Part 3 was to identify reasons for preference of a particular FC type and to document details surrounding product use/non-use.
Interventions
DEVICEPath Women's Condom
comparison between 3 types of female condoms
DEVICEFC2 female condom
comparison between 3 types of female condoms
DEVICEReddy 6 female condom (V-Amour)
comparison between 3 types of female condoms
Sponsors
United States Agency for International Development (USAID)
University of Witwatersrand, South Africa
FHI 360
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All women enrolled in this research must meet the following selection criteria: 1. must be at least 18 years of age. 2. must be literate (able to read a newspaper or letter easily). 3. must be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrollment). 4. must be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study. 5. must have been in a sexual relationship with this partner for at least 6 months. 6. must be without evidence of STI as determined through syndromic diagnosis and vaginal examination. 7. must be on hormonal or other non-barrier contraception (e.g. OCs, injectables, IUD, or have had a tubal sterilization or be post-menopausal-defined as 12 months with no period). 8. must be willing to give informed consent. 9. must be able to complete condom use log. 10. must be willing to use the study condoms as directed. 11. must be willing to adhere to the follow-up schedule and all study procedures. 12. must have successfully completed a given phase of study before advancing into subsequent phases (e.g. successfully completing Part 1 before advancing to Part 2, etc.). 13. must be willing to provide research study staff with an address, phone number or other locator information while participating in the study. 14. must be willing to participate in the study for up to six months. *
Exclusion criteria
1. must not be a sex worker. 2. must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study. 3. must not be breastfeeding. 4. must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preference of female condom by type | 3 months | The objective of Part 1 is to familiarize each participant with the use characteristics of the three female condom types in order to minimize learning curve effect in subsequent phases of study. In Part 2, a 'simulated market' will be created in order to determine an unbiased, free choice preference for a particular FC type. Part 3 will detail the reasons for participants' selection/preference of specific FC types. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of each of the female condom types | 3 months | safety measured by number of particpants with adverse events |
| Function of each of the female condom types | 3 Months | FC function measured by number of female condoms that failed during use (e.g. breakage, slippage and invagination) as self-reported by subjects through coital logs |
Countries
South Africa
Outcome results
None listed