Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom
Condition: Pregnancy Prevention
Study type: Interventional

Summary: 
      This research study aims to assess the effectiveness of three female condoms [Cupid, Cupid 2
      and Female Condom 2(FC2)] for the prevention of pregnancy among women choosing the female
      condom (FC) as their method of fertility regulation. Participants will be followed-up monthly
      for up to seven months. A daily diary will be used to record menstrual pattern, acts of
      intercourse and details of condom usage.
    

Detailed description: 
      This research study aims to assess the effectiveness of three female condoms (Cupid, Cupid 2
      and FC2) for the prevention of pregnancy among women choosing the female condom (FC) as their
      method of fertility regulation.

      The study is a randomized comparative prospective follow-up study. Participants will be
      followed-up monthly for up to seven months. A daily diary will be used to record menstrual
      pattern, acts of intercourse and details of condom usage. The primary endpoint will be the
      occurrence of pregnancy or use of emergency contraception, and the diary information will
      allow pregnancy rates to be characterized by patterns of condom use and failures
      (contraceptive efficacy and effectiveness rates).

      The target population will be 780 urban and peri urban, sexually active women who are
      experienced users of FCs. Recruitment will be from a family planning clinic associated with
      the MatCH Research Unit (MRU), University of the Witwatersrand, Durban, South Africa and the
      surrounding community. The woman rather than the couple will be the unit of observation since
      the major outcome to be measured is pregnancy. There will be monthly follow-ups of
      participants from enrollment until after the 6th menstrual cycle (month 1,2,3,4,5 and 6). All
      visits will be conducted at the research site. The diary, to be completed on a daily basis by
      the participants, will indicate whether the coital frequency differs significantly between
      subgroups (students, urban, peri-urban).

      Female clients of the Commercial City Clinic and other women presenting at the site will be
      informed about the study. If a potential participant expresses interest in participating, she
      will be given the study information sheet to read, which will describe the study requirements
      and her potential role in the study. If she agrees to take part in the research, she will be
      asked to provide written informed consent. The participant will be administered the screening
      form to determine whether she meets study inclusion criteria.

      Eligible women who agree to participate will undergo a baseline interview. Information
      collected during the enrollment interview will include demographic data and information on
      the participant's general and reproductive health. The data collected on reproductive health
      variables will include the date of last menstrual period (LMP), history of pregnancies,
      births and miscarriages, a contraceptive history as well as a sexual history. After
      completion of the interview, the participant will be randomized to the use on one FC type.

      Male partners will not be asked to sign an Informed Consent as they will not be required to
      participate in the research, but female participants will be given an additional information
      sheet if they desire to give to the male partner to tell them about the study.

      If a potential participant does not wish to be enrolled, she will be provided with referral
      (should she wish) for any reproductive health services according to normal clinical practice
      at the study site. Her reasons will be recorded on the log of refusals. This information will
      be used to compile statistics on the participation rates and reasons for nonparticipation.

      Although all study participants are required to have ever used a FC, some may have not used
      the FC they have been randomized to and have experience with other FC types. All participants
      will be retrained regardless of previous FC use using a pelvic model. The study staff will
      demonstrate FC insertion and train the participants in the proper use of the randomized FC
      type. Further, they will provide instruction on how to complete the condom use log and the
      study diary. She will also receive instructions on use in her preferred language (English or
      Zulu).

      The participants will be given their first study packet which will contain either Cupid,
      Cupid 2 or FC2 with a diary for the first month of the study. Research staff will discuss
      with the participant how many condoms they require for the month. The participants will be
      instructed how to complete the diary card. The first follow-up visit should occur
      approximately one month after enrollment and should be pre-scheduled. The date of the first
      follow-up visit should be written in an appointment card and on the designated location on
      the Condom diary card. Participants who finish using their condoms prior to their scheduled
      follow-up visit, will be encouraged to contact MRU for a resupply.

      There will be six follow-up visits in person at 1, 2, 3, 4, 5, and 6 months. Telephonic
      follow-up will be conducted between 7-14 days post enrollment to confirm any queries or
      problems in use of condoms or diaries.

      Participants will be administered a follow-up survey about their experiences using their
      randomized FC, whether there has been a delay in expected onset of menses, the date of last
      menstrual period, and information on the use of other contraceptives since the last visit.
      The daily diary will also be reviewed at each visit for completeness and accuracy. A
      pregnancy test will be carried out at every on-site visit. Any reported or confirmed
      pregnancies will include counseling and referral to an antenatal or other healthcare
      facility. The final follow up visit will be scheduled after 6th menstrual cycle.

      Women will be discontinued from the study at any stage during follow-up for: pregnancy,
      unwillingness to continue use of FCs or change to a non-study contraceptive method as her
      main contraceptive method, or refusal to be followed up.

      Block randomization will be used. A statistician (not otherwise involved in this study) will
      develop the random allocation sequence using a validated statistical program in Stata
      (StataCorp LP, College Station, Texas, USA). Use-order assignments will be generated via the
      RedCap electronic program. The statistician will be blinded until all data have been captured
      and the primary analysis programs have been verified. Due to dissimilarities of the study
      products, it will not be possible to blind participants and clinic staff associated with the
      project.
    

Intervention name(s): FC2 Condom; Cupid Condom; Cupid 2 Condom
Intervention type(s): Device; Device; Device
Intervention description(s): FC2: FC2 is composed of a synthetic nitrile rubber latex and 170mm in length. It has a flexible inner ring as the internal retention mechanism and a circular ring as the outer retention mechanism at the open end of the condom. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is available in clear and other colors/scents. It is manufactured by Female Health Company, USA and has USFDA, World Health Organisation (WHO)/United Nations Populations Fund (UNFPA) and South African Bureau of Standards (SABS) approval; Cupid is composed of a Natural rubber latex and is 155mm in length. It has a Medical grade sponge as the internal retention mechanism and an octagonal outer frame as the outer retention mechanism. It is pre-lubricated with silicone oil. It has a shelf-life of 3 years and is available in clear and red color, vanilla scented variety. It is manufactured by Cupid Ltd, India and has WHO)/UNFPA, India Drug Control Authority, Conformitè Europëenne (CE) Mark of the European Union (EU) and SABS approval; Cupid2 is composed of a Natural rubber latex and is 125mm in length. It has a Medical grade sponge as the internal retention mechanism and an octagonal outer frame as the outer retention mechanism. It is pre-lubricated with silicone oil. It has a shelf-life of 3 years and is available in Clear and purple color, vanilla scented variety. It is manufactured by Cupid Ltd, India and has WHO)/UNFPA, India Drug Control Authority, CE Mark of the EU and SABS approval
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This research study will be a parallel randomized controlled trial to assess the effectiveness of three female condoms (Cupid, Cupid 2 and FC2) for the prevention of pregnancy among women choosing the female condom as their method of fertility regulation
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Female condom; Pregnancy Prevention; Sexually transmitted infection prevention; Condom acceptability; FC2; Cupid