Promoting CSD500 Use Among Women in Established Relationships

NCT02934620 | Completed Results DMC

• 1 other identifier: 2015H0242
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

PSA; Unprotected Sex

Keywords

pregnancy; condom; HIV; sexually transmitted infections

Outcome Measures

Primary Outcomes (3)

• Number of Female Participants With Positive PSA at 2-Month Visit

  A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.

  Vaginal swab collected at 2-month follow-up visit

• Number of Female Participants With Positive PSA at 4-Month Visit

  A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.

  Vaginal swab collected at 4-month follow-up visit

• Number of Female Participants With Positive PSA at 6-Month Visit

  A double-headed vaginal swab is collected for each female participant to assess for PSA positivity.

  Vaginal swab collected at 6-month follow-up visit

Secondary Outcomes (6)

• Number of Female Participants With Self-reported Condomless Sex at 2-month Follow-up Visit

  Measured at 2-month follow-up visit

• Quality of Sexual Experience (QSE) Scale Scores Among Participants at 6-month Visit

  Measured among participants at at 6-month follow-up visit

• 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

• 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

• Number of Female Participants With Self-reported Condomless Sex at 4-month Follow-up Visit

  Measured at 4-month follow-up visit

Study Arms (2)

CSD500 Condom

EXPERIMENTAL

Receive CSD500 condoms with condom counseling to use them for sexual pleasure.

Device: CSD500 Condom; Behavioral: Condom Counseling

Standard Condom

ACTIVE COMPARATOR

Receive the standard condom with condom counseling to use them for pregnancy and disease prevention.

Device: Standard Condom; Behavioral: Condom Counseling

Interventions

CSD500 Condom DEVICE

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.

Also known as: Blue Diamond

CSD500 Condom

Standard Condom DEVICE

The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.

Standard Condom

Condom Counseling BEHAVIORAL

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.

CSD500 Condom; Standard Condom

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Ministry of Health, Vietnam: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Thanh Hoa Provincial Centre of Reproductive Health

Thanh Hóa, Thanh Hóa Province, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 35176037 DERIVED

MeSH Terms

Conditions

Unsafe Sex; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Maria Gallo
• Organization: Ohio State University, College of Public Health

gallo.86@osu.edu

16146882145

Study Officials

• Maria Gallo, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• John Casterline, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Rebecca Andridge, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Marcia Hobbs, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Nghia Nguyen, MD, PhD

  Ministry of Health, Vietnam

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 17, 2016
• Study Start: June 9, 2017
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)