Functional Performance and Acceptability Study of Synthetic Nitrile, and Latex Graphene, Compared to Standard Latex Male Condom
Condition: Functional Performance
Study type: Interventional

Summary: 
      Two new male condoms have been developed - one made of synthetic nitrile and the other made
      of latex graphene. Both new condoms are of the same design as a standard latex male condom.
      The aim of this study is to evaluate the functional performance of two new male condoms
      compared to a control latex male condom. Couples enrolled in the study will be asked to use
      five latex graphene, five synthetic nitrile and five latex male condoms in a randomized type
      order. Function, safety, and acceptability will be assessed at three follow-up visits
      approximately one month apart after enrolment.
    

Detailed description: 
      Two new male condoms have been developed - one made of synthetic nitrile and the other made
      of latex graphene. Both new condoms are of the same design as a standard latex male condom.

      Purpose: The aim of the study is to evaluate the functional performance of two new male
      condoms compared to a control latex male condom.

      Study design: The study is a randomized three-period cross-over trial of two new male condoms
      and a control latex male condom. The study will enrol 240 couples, anticipating that at least
      200 couples will complete the study. Each couple will be asked to use five latex graphene,
      five synthetic nitrile and five latex male condoms in a randomized type order. Function,
      safety, and acceptability will be assessed at three follow-up visits approximately one month
      apart after enrolment. Couples will complete a Condom Log at their homes which gathers data
      on experience after use of each condom.

      Primary Objective: To ascertain the functional performance of a latex graphene and a
      synthetic nitrile compared to a control latex male condom. Primary endpoints will be total
      clinical failure and total condom failure.

      Secondary Objectives: Acceptability and safety data (as determined by the number of adverse
      events) occurring with each male condom type.

      Population: The target population will be 240 urban, sexually-active couples who are
      experienced users of male condoms. Recruitment will be from the Commercial City MatCH
      Research Unit (MRU) site and other workplace sites in the eThekwini District.

      Men and women will be told about the study. If a man/woman expresses interest in
      participating, they will be given the study information sheet to read, which will describe
      the study requirements and their potential role/partners potential in the study. If they
      agree to take part in the research, they will be asked to give the information sheet to their
      partner. If both partners in the couple are willing to participate, they will be invited to
      visit the enrolment site or the MRU Commercial City site and asked to provide written
      informed consent. Both partners will be screened to ensure they meet the requirements for
      study participation.

      A physical examination will be undertaken to exclude visible symptoms of sexually transmitted
      infections. If symptoms are observed the participant will be referred to a Department of
      Health clinic or their doctor for treatment. A urine pregnancy test will be conducted at
      screening to exclude pregnancy. Both partners in the couple will need to provide the study
      with a copy of HIV results which are not older than 2 months. If HIV testing results are not
      available, voluntary HIV counselling and testing will be offered and conducted by study
      staff.

      The consent process and all checklists, condom use logs and surveys used in the research will
      be written and conducted in a language that is understandable to the participant, and all
      relevant documents will be translated into isiZulu. Enrolled participants will be asked to
      use five latex graphene, five synthetic nitrile and five latex male condoms. They will be
      asked to return for follow-up after using five of each type of device.

      At enrolment, baseline data will be gathered on participant demographics and past male condom
      use via the baseline questionnaire using a dildo model, the study staff will demonstrate male
      condom fitting and train the participants in the proper use of their first assigned male
      condom. Further, they will re-emphasize the instructions on how to complete the condom use
      log. Couples will be given one condom log to complete together. Couples will be told that
      they do not have to use the study male condoms during consecutive acts of intercourse. They
      will also be counselled on Pre Exposure Prophylaxis (PrEP) and referred to a local facility
      that provides PrEP should they wish to initiate PrEP. The study staff will discuss with the
      couple an approximate timeframe for use of all five condoms and a suitable follow-up date
      will be scheduled. This date will be noted on an appointment slip. Couples will be encouraged
      to come back if their condoms are finished before the due date and will be given the research
      study contact details to call for any appointment changes.

      During the first follow-up visit, couples will be interviewed about their first assigned
      condom type and they will receive their next condom packet within their second assigned
      (randomized) use sequence. In the second follow-up visit, couples will be interviewed about
      their second assigned condom type and they will receive their next condom packet within their
      third assigned (randomized) use sequence.

      In the third follow-up visit, couples will be interviewed about their third assigned condom
      type and will be discontinued from study participation. Data on device function, safety and
      acceptability for each condom type will be collected during follow-up visits.
    

Intervention name(s): Synthetic nitrite Condom; Latex and graphene Condom; Standard latex condom
Intervention type(s): Device; Device; Device
Intervention description(s): The condoms is composed of a synthetic nitrile rubber latex and 170 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and clear and colourless. It is manufactured by Karex Industries. It is currently experimental.; The condom is composed of a natural rubber latex with graphene. It is 170 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is greyish in colour. It is manufactured by Karex Industries. It is currently experimental.; The condoms is composed of a natural rubber latex. It is 180 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is natural in colour. It is manufactured by Karex Industries. It has World Health Organisation (WHO)/UNFPA, India Drug Control Authority, Conformitè Europëenne (CE) Mark of the European Union, South African Bureau of Standards and US FDA approval
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a randomized cross-over trial to evaluate the functional performance of two new male condoms compared to a control latex male condom.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: synthetic nitrile male condom; latex graphene male condom; latex male condom