Clinical trial NCT02934620: Promoting CSD500 Use Among Women in Established Relationships
Official title: Promoting CSD500 Use Among Women in Established Relationships
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PSA
Unprotected Sex
Keywords: pregnancy
condom
HIV
sexually transmitted infections
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Vietnam
name: University of North Carolina, Chapel Hill
First posted: 2016-10-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Female Participants With Positive PSA at 2-Month Visit
timeFrame: Vaginal swab collected at 2-month follow-up visit
measure: Number of Female Participants With Positive PSA at 4-Month Visit
timeFrame: Vaginal swab collected at 4-month follow-up visit
measure: Number of Female Participants With Positive PSA at 6-Month Visit
timeFrame: Vaginal swab collected at 6-month follow-up visit
Secondary outcomes:
measure: Number of Female Participants With Self-reported Condomless Sex at 2-month Follow-up Visit
timeFrame: Measured at 2-month follow-up visit
measure: Quality of Sexual Experience (QSE) Scale Scores Among Participants at 6-month Visit
timeFrame: Measured among participants at at 6-month follow-up visit
measure: Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 2-month Visit
timeFrame: Measured among female participants at at 2-month follow-up visit
measure: Quality of Sexual Experience (QSE) Scale Scores Among Female Participants at 4-month Visit
timeFrame: Measured among female participants at at 4-month follow-up visit
measure: Number of Female Participants With Self-reported Condomless Sex at 4-month Follow-up Visit
timeFrame: Measured at 4-month follow-up visit
measure: Number of Female Participants With Self-reported Condomless Sex at 6-month Follow-up Visit
timeFrame: Measured at 6-month follow-up visit
Other outcomes:
Locations:
city: Thanh Hoa
country: Vietnam
facility: Thanh Hoa Provincial Centre of Reproductive Health
state: Thanh Hoa Province
Study officials:
affiliation: Ohio State University
name: Maria Gallo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: John Casterline, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Rebecca Andridge, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Marcia Hobbs, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, Vietnam
name: Nghia Nguyen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen NC, Luong TN, Le VT, Hobbs M, Andridge R, Casterline J, Gallo MF. Effectiveness of erectogenic condom against semen exposure among women in Vietnam: Randomized controlled trial. PLoS One. 2022 Feb 17;17(2):e0263503. doi: 10.1371/journal.pone.0263503. eCollection 2022.