Promoting CSD500 Use Among Women in Established Relationships

Study Overview
=================
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 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.

Official Title
-----------------
Promoting CSD500 Use Among Women in Established Relationships

Conditions
-----------------
PSA, Unprotected Sex

Intervention / Treatment
-----------------
* Device: CSD500 Condom
* Device: Standard Condom
* Behavioral: Condom Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSD500 Condom<br>Receive CSD500 condoms with condom counseling to use them for sexual pleasure. | Device: CSD500 Condom<br>* 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.<br>* Other names: Blue Diamond;Behavioral: Condom Counseling<br>* 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.<br>|
| Active Comparator: Standard Condom<br>Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. | Device: Standard Condom<br>* The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.<br>Behavioral: Condom Counseling<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA positivity | A double-headed vaginal swab is collected for each participant to assess for PSA positivity. | Vaginal swab collected at 2-month follow-up visit | 
| PSA positivity | A double-headed vaginal swab is collected for each participant to assess for PSA positivity. | Vaginal swab collected at 4-month follow-up visit | 
| PSA positivity | A double-headed vaginal swab is collected for each participant to assess for PSA positivity. | Vaginal swab collected at 6-month follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported condomless sex | Investigators will compare frequency of self-reports of recent sex without a condom between the two arms. | Measured at 2, 4 and 6 month follow-up visits | 
| Quality of Sexual Experience (QSE) Scale Scores | The QSE Scale modified to add a question about pleasure related to the act's duration will be used to evaluate the effects of CSD500 provision on men and women's reports of sexual pleasure compared to the standard condom. | Measured at 2, 4 and 6 month follow-up visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, condom, HIV, sexually transmitted infections