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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02934620 |
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Date of registration:
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10/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Promoting CSD500 Use Among Women in Established Relationships
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Scientific title:
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Promoting CSD500 Use Among Women in Established Relationships |
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Date of first enrolment:
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June 9, 2017 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02934620 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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John Casterline, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio State University |
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Name:
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Rebecca Andridge, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio State University |
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Name:
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Nghia Nguyen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ministry of Health, Vietnam |
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Name:
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Maria Gallo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio State University |
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Name:
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Marcia Hobbs, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Unprotected Sex
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PSA
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Intervention(s)
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Behavioral: Condom Counseling
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Device: CSD500 Condom
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Device: Standard Condom
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Primary Outcome(s)
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PSA positivity
[Time Frame: Vaginal swab collected at 2-month follow-up visit]
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PSA positivity
[Time Frame: Vaginal swab collected at 4-month follow-up visit]
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PSA positivity
[Time Frame: Vaginal swab collected at 6-month follow-up visit]
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Secondary Outcome(s)
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Self-reported condomless sex
[Time Frame: Measured at 2, 4 and 6 month follow-up visits]
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Quality of Sexual Experience (QSE) Scale Scores
[Time Frame: Measured at 2, 4 and 6 month follow-up visits]
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Secondary ID(s)
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2015H0242
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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