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

November 4, 2014 updated by: Centers for Disease Control and Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

414

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jamaica
      • Kingston, Jamaica, 5
        • Epidemiology Research Training Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate-specific antigen (PSA)
Time Frame: 3 months
Number of women with recent exposure to semen as measured by the detection of prostate-specific antigen (PSA) in vaginal swabs
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported exposure to semen
Time Frame: 3 months
Number of women reporting recent exposure to semen
3 months
Side effects
Time Frame: 3 months
Number of women with side effects, including changes in menstrual bleeding patterns, and mean change in body weight
3 months
Product discontinuation
Time Frame: 3 months
Number of women in the immediate implant arm who discontinue implant use during the study
3 months
Acceptability
Time Frame: 3 months
Number of women in the immediate implant arm who perceive the implant as acceptable
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

FHI 360
The University of The West Indies
Ministry of Health, Jamaica

Investigators

  • Study Chair: Carole Rattray, DM, University of West Indies
  • Principal Investigator: Elizabeth Costenbader, PhD, FHI 360
  • Principal Investigator: Athena Kourtis, MD, PhD, MPH, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (Estimate)

September 13, 2012

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDC-NCCDPHP-6163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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