Promoting CSD500 Use Among Women in Established Relationships
Condition: PSA; Unprotected Sex
Study type: Interventional

Summary: 
      Globally, women in established relationships remain at risk for unintended pregnancy and
      sexually transmitted infections (STIs), including HIV. In Vietnam, the location of the
      proposed research, unmet need for contraception is substantial as reflected in the nation's
      high abortion ratio. Married women account for about one-third of HIV cases in Vietnam, and
      among this group, most were exposed to the virus through sexual activity with their husband.
      Condoms will remain crucial for prevention for some time to come. Sustained condom use,
      however, is notoriously difficult to achieve. A key barrier to the consistent use of condoms
      is their effect on sexual pleasure. Although sexual pleasure is a primary motivation for
      engaging in sex and is an integral part of overall sexual health, most programs to improve
      sexual health operate within a pregnancy and disease-prevention paradigm. A new condom,
      CSD500, containing an erectogenic drug was developed for use among healthy couples to improve
      sexual pleasure by increasing penile firmness, size and erection duration. The overall
      objective of the proposed two-arm randomized trial is to test whether promoting the novel
      condom CSD500 for improved sexual pleasure results in couples having less unprotected vaginal
      sex. Investigators will measure the occurrence of unprotected vaginal sex by testing women's
      vaginal fluid for the presence of prostate-specific antigen (PSA), an objective, biological
      marker of recent semen exposure. Investigators will randomize 500 adult, heterosexual,
      monogamous couples in Thanh Hoa province, Vietnam to receive either CSD500 for sexual
      pleasure or the standard condom currently provided only for pregnancy and disease prevention
      to patients during routine care. Study staff will interview female participants at enrollment
      and after 2, 4, and 6 months and their male partners at the 6-month visit. Study clinicians
      will sample vaginal fluid from female participants at all visits to test for the presence of
      PSA.
    

Detailed description: 
      This randomized controlled trial will test whether promoting the novel condom CSD500 (Futura
      Medical Developments; Surrey, UK) for improved sexual pleasure results in couples having less
      unprotected vaginal sex - measured with a biological marker of recent semen exposure -
      compared to the promotion of a standard condom for disease and pregnancy prevention. CSD500
      contains an erectogenic drug and was developed to improve sexual pleasure by increasing
      penile firmness, size, and erection duration.

      Investigators will recruit eligible, monogamous, heterosexual couples at Thanh Hoa Provincial
      Centre of Reproductive Health in Vietnam to participate in a randomized controlled trial
      (RCT) of two balanced arms of approximately 250 couples each. At enrollment and at three
      follow-up visits scheduled at 2, 4 and 6 months after enrollment, study staff will provide
      condom counseling, will collect vaginal swabs to test for the semen biomarker,
      prostate-specific antigen (PSA), and will administer a questionnaire to the female
      participants on their demographics, sexual and condom-related attitudes and practices,
      including sexual pleasure and perceptions of partner's sexual pleasure. Although the
      intervention is directed to the women, couples will be enrolled to ensure that the male
      partners consent to CSD500 use. After enrollment, male participants will not participate in
      study visit activities, including data collection, until the time of their female partner's
      final 6-month visit. Because of the differences in counseling messages, participants and
      study staff at the site cannot be blinded to arm assignment.
    

Intervention name(s): CSD500 Condom; Standard Condom; Condom Counseling
Intervention type(s): Device; Device; Behavioral
Intervention description(s): CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.; The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.; The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
Other intervention name(s): Blue Diamond
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy; condom; HIV; sexually transmitted infections