A Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica (SIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Centers for Disease Control and Prevention
Sponsor:
Collaborators:
FHI 360
Ministry of Health, Kingston, Jamaica
The University of The West Indies
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01684358
First received: September 10, 2012
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Women Wanting Contraceptive Implant for Pregnancy Prevention
Device: Sino-implant (II)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of women with recent exposure to semen as measured by the detection of prostate-specific antigen (PSA) in vaginal swabs


Secondary Outcome Measures:
  • Self-reported exposure to semen [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of women reporting recent exposure to semen

  • Side effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of women with side effects, including changes in menstrual bleeding patterns, and mean change in body weight

  • Product discontinuation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of women in the immediate implant arm who discontinue implant use during the study

  • Acceptability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of women in the immediate implant arm who perceive the implant as acceptable


Estimated Enrollment: 414
Study Start Date: September 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate implant
Sino-implant (II) inserted at enrollment visit
Device: Sino-implant (II)
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 Names:
  • Zarin
  • TRUST
  • Femplant
Active Comparator: Delayed implant
Sino-implant (II) inserted at 3-month follow-up visit
Device: Sino-implant (II)
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 Names:
  • Zarin
  • TRUST
  • Femplant

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be willing to be randomized to receive the implant at the enrollment visit or in three months;
  • Be 18-44 years of age;
  • Not known to be HIV-positive;
  • Have a negative pregnancy test at baseline;
  • Not currently using an intrauterine device or system, a contraceptive implant, or injectable contraception;
  • Not planning to start use an intrauterine contraceptive device or system or injectable contraception in the next three months;
  • Not have had surgical sterilization or plan to have it in the next three months;
  • Not have medical contraindication to implant use, including lactation within first 6 weeks postpartum, acute deep venous thrombosis or pulmonary embolism, lupus, migraine with aura, unexplained vaginal bleeding, current or history of breast cancer,severe cirrhosis, liver tumors, history of stroke, and current or history of ischaemic heart disease;
  • Be willing to return to the clinic for two follow-up visits over the next three months; and
  • Be otherwise a good candidate for study participation based on investigator assessment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684358

Contacts
Contact: Carole Rattray, DM 876-618-1731 kay.rattray@gmail.com
Contact: Tina Hylton-Kong, MBBS, MPH 876-948-8002 tina.hyltonkong@gmail.com

Locations
Jamaica
Epidemiology Research Training Unit Recruiting
Kingston, Jamaica, 5
Contact: Carole Rattray, DM    876-618-1731    kay.rattray@gmail.com   
Principal Investigator: Carole Rattray, DM         
Sponsors and Collaborators
FHI 360
Ministry of Health, Kingston, Jamaica
The University of The West Indies
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01684358     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-6163
Study First Received: September 10, 2012
Last Updated: April 18, 2013
Health Authority: United States: Federal Government
Jamaica: Ministry of Health
Jamaica: University of West Indies, Institutional Review Board

Keywords provided by Centers for Disease Control and Prevention:
Prostate-specific antigen
Contraceptive implant
Biological marker
Condoms
Women

ClinicalTrials.gov processed this record on September 30, 2014