A Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica
Condition: Women Wanting Contraceptive Implant for Pregnancy Prevention
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Sino-implant (II)
Intervention type(s): Device
Intervention description(s): Sino-implant (II) (Shanghai Dahua Pharmaceutical Co, Ltd.; Shanghai, China), a contraceptive implant with two rods each of which contain 75 mg of levonorgestrel.
Other intervention name(s): Zarin; TRUST; Femplant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prostate-specific antigen; Contraceptive implant; Biological marker; Condoms; Women