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NCT ID: NCT02934620 Completed - PSA Clinical Trials

Promoting CSD500 Use Among Women in Established Relationships

Start date: June 9, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01749618 Completed - PsA Clinical Trials

Closing the Gap in Care in Seronegative Inflammatory Arthritis

Metrix II
Start date: November 2012
Phase: N/A
Study type: Interventional

Rheumatologists treating patients with seronegative arthritis will be randomized to treat their patients to a target or to treat their patients under their usual standard of care. All physicians will perform an initial chart audit. Following the initial chart audit, all physicians in the treat-to-target group will receive accredited educational training. Six months after the initial chart audit, all physicians will perform a repeat audit to see if patients are assessed more systematically and treated to a target of low disease state.