Promoting CSD500 Use Among Women in Established Relationships

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 heterosexual couples each, for a total of 500 couples, comprised of 1000 individuals. 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.

Inclusion criteria

(for women):

• Not currently using a modern contraceptive method other than condoms or intending to start using a modern contraceptive method other than condoms in the next 6 months;
• Willing to use assigned study condoms as the sole method of contraception for the next six months;
• Not breastfeeding;
• Not known to be pregnant;
• Want to avoid pregnancy for at least the next six months; and
• Be in a monogamous relationship for at least the past six months with her current male partner.

Exclusion criteria

(for couples):

Couples are ineligible for study participation if either person in the couple is known to be HIV-positive or has any of the following contraindications to CSD500 use:

• History of low blood pressure or heart condition;
• Current use of medication for anemia, blood pressure, erectile dysfunction, migraines, headaches or glaucoma;
• Inflamed or broken skin that the condom could come into contact with; or
• Latex allergy or sensitivity.