Promoting CSD500 Use Among Women in Established Relationships

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

Interventions

DEVICE

CSD500 Condom

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.

DEVICE

Standard Condom

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

BEHAVIORAL

Condom Counseling

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.

Sponsors & Collaborators

• Ministry of Health, Vietnam

  collaborator OTHER_GOV

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Ohio State University

  lead OTHER

Principal Investigators

• Maria Gallo, PhD · Ohio State University

• John Casterline, PhD · Ohio State University

• Rebecca Andridge, PhD · Ohio State University

• Marcia Hobbs, PhD · University of North Carolina

• Nghia Nguyen, MD, PhD · Ministry of Health, Vietnam

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-06-09

Primary Completion

2020-02-19

Completion

2020-02-19

Countries

• Vietnam

Study Locations