Women Wanting Contraceptive Implant for Pregnancy Prevention Clinical Trial
Official title:
A Randomized Controlled Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica
This unblinded, randomized controlled trial (RCT) among women to determine:
1)if unprotected sex as measured prostate-specific antigen (PSA) will be more among women
who receive a contraceptive implant immediately at baseline during three months of follow up
compared to women who receive the implant at the three month follow-up visit.
This unblinded, randomized controlled trial (RCT) will assess whether the use of a
contraceptive implant leads to more sex unprotected by a condom, as measured by the
detection of a biological marker of exposure to semen in vaginal fluid, among women in
Kingston, Jamaica.
Eligible women will be non-pregnant, not known to be HIV-positive, 18-44 years of age, not
already using a long-acting method of contraception, without contraindications to implant
use, and willing to use the Sino-implant (II). Eligible women will be recruited from the
Comprehensive Health Centre Center of Excellence (CHC) in Kingston, Jamaica and from the
community. Women who give written consent for study participation will be enrolled in the
study and randomized to one of the two study groups: 1) "immediate implant" insertion or 2)
"delayed implant" insertion (i.e., when their study participation ends after three months of
follow up). All participants will receive safer sex counseling, will be supplied with
condoms, and will be administered a baseline questionnaire on demographics, reproductive
history and contraceptive and sexual practices. A study clinician will perform a pelvic
examination during which a double-headed vaginal swab will be collected to be tested for
prostate-specific antigen (PSA), which is a semen biomarker. Participants will be asked to
return for follow-up visits scheduled at 1 and 3 months after enrollment, at which times
they will have another double-headed vaginal swab collected during a pelvic examination for
testing for PSA and will be administered follow-up questionnaires. Participants in the
"delayed implant" group will have the Sino-implant (II) inserted at the 3-month visit if
they still want the device.
Primary objective: To determine whether the frequency of PSA detection during three months
of follow up is higher in the immediate implant group than in the delayed implant group.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention