Condom Performance in a Longitudinal Enhanced Assessment of User Experiences
Condition: HIV
Study type: Interventional

Summary: 
      This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with
      women (MSW) in a double-blind, three-way randomized crossover trial with conditions of
      fitted, thin, and standard condoms. The study will provide fitted condoms in 56 sizes based
      on combinations of length (approximately 10 mm increments) and circumference (approximately 2
      mm increments), with user-determined size based on a paper template measurement instrument.

      Participants will be randomly assigned to the sequence in which the crossover intervention
      conditions (fitted, thin, and standard condoms) occur, with five study condoms provided for
      each condition. Participants will attend at least four, and up to seven, biweekly study
      visits.
    

Detailed description: 
      Study objectives are to establish label indications for pleasure and patient preference for
      fitted condoms, establish label indication for anal sex for fitted, thin, and standard
      condoms, and establish a label indication for decreased clinical failure of fitted condoms
      for anal sex.

      The study will enroll 252 MSM and 252 men who sex with women (MSW) into a double-blind,
      three-way randomized crossover trial with conditions of fitted, thin, and standard condoms.
      For MSM enrolled in the trial we will assess outcomes based on anal sex, and for MSW we will
      assess outcomes based on vaginal sex. The study will provide fitted condoms in 56 sizes based
      on combinations of length (approximately 10 mm increments) and circumference (approximately 2
      mm increments), with user-determined size based on a paper template measurement instrument.

      For purposes of this study, a "standard" condom is defined by dimensions commonly sourced by
      the United Nations Population Fund (UNFPA) and United States Agency for International
      Development (USAID), which procures the majority of the world's condoms. These dimensions are
      185mm ± 10mm length, 53mm ± 2mm width, and 70 microns ± 10 microns thick. "Thin" condoms for
      this study will be of identical width and length to "standard", but 50 microns ± 5 microns
      thick. Fitted condoms will be produced in a range of sizes with thickness of 70 microns ± 10
      microns, with a participant's fitted size as determined by their use of a fitting system
      consisting of a paper template graduated with non-sequential numbering and lettering. Condoms
      will be manufactured using the same latex formulation and silicone lubricants (approximately
      400mg per condom), and with similar parallel wall designs.

      Every participant in the trial will receive a set of five fitted condoms (fitted condition),
      a set of five thin condoms (thin condition), and a set of five standard condoms (standard
      condition) over a series of study visits. Event-level data based on a home coital log will be
      collected regarding pleasure and total clinical failure, and data regarding overall condom
      preference will be collected at the final study visit. Participants will be randomly assigned
      to the sequence in which the crossover intervention conditions (fitted, thin, and standard)
      occur. Each participant will attend at least four, and up to seven, biweekly study visits.
      Participants will be given up to four weeks to use each study condom set; after 4 weeks with
      a set of condoms, participants will be automatically crossed over into the next study
      condition. If all condoms are used within the first two weeks, participants will crossover to
      the next randomized condition.

      Participants will be blinded, with all condoms produced in plain foils with two-digit
      identifying codes, and role-based blinding will be conducted for study staff with the
      statistician and PI blinded. Participants will be trained in appropriate condom use, fitted
      condom sizing, study instructions such as only using study lubricant, and daily coital log
      completion. Participants will complete mobile-optimized, web-based home coital logs as soon
      as possible following any vaginal or anal sex acts. To assist participants in timely
      completion, there will be a daily check-in through Short Message Service (SMS) (via text
      message) with a reminder initiated if no sexual event has been recently reported. The coital
      log will include outcome measures for pleasure and for condom failure. The final visit survey
      will measure overall condom preference.
    

Intervention name(s): 5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms
Intervention type(s): Device
Intervention description(s): Fitted condoms are available in 56 sizes based on combinations of length (approximately 10mm increments) and circumference (approximately 2 mm increments). Fitted condom thickness is 70 microns ± 10 microns. Appropriate condom size is user-determined with a paper template fitting tool graduated with non-sequential numbering and lettering for maximum privacy. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
Thin condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 50 microns ± 5 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
Standard condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 70 microns ± 10 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: We recruited 504 participants into the crossover trial. Participants were randomized into one of six sequences, each representing the order in which a participant would receive batches of five study condoms of a particular type.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sexually Transmitted Infections; Condoms; Contraceptive Devices; HIV