Promoting CSD500 Use Among Women in Established Relationships

Not Applicable

Completed

Conditions: PSA
Unprotected Sex

Interventions: Device: Standard Condom
Device: CSD500 Condom
Behavioral: Condom Counseling

Registration Number: NCT02934620

Lead Sponsor: Ohio State University

Brief 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, comprised of a total of 1000 individuals, 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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSD500 Condom	Condom Counseling	Receive CSD500 condoms with condom counseling to use them for sexual pleasure.
Standard Condom	Standard Condom	Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.
CSD500 Condom	CSD500 Condom	Receive CSD500 condoms with condom counseling to use them for sexual pleasure.
Standard Condom	Condom Counseling	Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.

Primary Outcome Measures

Name	Time	Method
Number of Female Participants With Positive PSA at 2-Month Visit	Vaginal swab collected at 2-month follow-up visit	A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.
Number of Female Participants With Positive PSA at 4-Month Visit	Vaginal swab collected at 4-month follow-up visit	A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.
Number of Female Participants With Positive PSA at 6-Month Visit	Vaginal swab collected at 6-month follow-up visit	A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.

Secondary Outcome Measures

Name	Time	Method
Number of Female Participants With Self-reported Condomless Sex at 2-month Follow-up Visit	Measured at 2-month follow-up visit	Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.
Quality of Sexual Experience (QSE) Scale Scores Among Participants at 6-month Visit	Measured among participants at at 6-month follow-up visit	The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women and men's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.
Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 2-month Visit	Measured among female participants at at 2-month follow-up visit	The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.
Number of Female Participants With Self-reported Condomless Sex at 4-month Follow-up Visit	Measured at 4-month follow-up visit	Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.
Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 4-month Visit	Measured among female participants at at 4-month follow-up visit	The Quality of Sexual Experience Scale was modified to add a question about pleasure related to the act's duration. The scale will be used to evaluate the effects of CSD500 provision on women's reports of sexual pleasure compared to the standard condom. The scale ranges from 0-7 points with a higher score indicating a higher-quality experience.
Number of Female Participants With Self-reported Condomless Sex at 6-month Follow-up Visit	Measured at 6-month follow-up visit	Investigators will compare frequency of self-reports of recent sex without a condom between the two arms of female participants.