Women Wanting Contraceptive Implant for Pregnancy PreventionSISNCT01684358
A Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica
A study testing Sino-implant (II) in people with Women Wanting Contraceptive Implant for Pregnancy Prevention, run by Centers for Disease Control and Prevention at 1 site in Jamaica.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Wanting Contraceptive Implant for Pregnancy Prevention
- What is being tested?
- Sino-implant (II)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteJamaica
- Study dates
- Sep 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Sino-implant (II)
- Keywords
- Prostate-specific antigen, Contraceptive implant, Biological marker, Condoms, Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sino-implant (II)Device
Also called Zarin, TRUST, Femplant
Sino-implant (II) (Shanghai Dahua Pharmaceutical Co, Ltd.; Shanghai, China), a contraceptive implant with two rods each of which contain 75 mg of levonorgestrel.
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant | Experimental | Sino-implant (II) inserted at enrollment visit Receives: Device: Sino-implant (II) |
| Delayed implant | Active comparator | Sino-implant (II) inserted at 3-month follow-up visit Receives: Device: Sino-implant (II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate-specific antigen (PSA)
Number of women with recent exposure to semen as measured by the detection of prostate-specific antigen (PSA) in vaginal swabs
Measured: 3 months
Secondary outcomes (4)
Self-reported exposure to semen
Number of women reporting recent exposure to semen
Measured: 3 months
Side effects
Number of women with side effects, including changes in menstrual bleeding patterns, and mean change in body weight
Measured: 3 months
Product discontinuation
Number of women in the immediate implant arm who discontinue implant use during the study
Measured: 3 months
Acceptability
Number of women in the immediate implant arm who perceive the implant as acceptable
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Women Wanting Contraceptive Implant for Pregnancy PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- FHI 360, Ministry of Health, Jamaica, The University of The West Indies
- Responsible party
- Sponsor
- Investigators
- Carole Rattray, DM, Study chair, University of West IndiesElizabeth Costenbader, PhD, Principal investigator, FHI 360Athena Kourtis, MD, PhD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684358
- Sponsor's protocol ID
- CDC-NCCDPHP-6163
- Acronym
- SIS
- Status last verified
- Apr 2013
- First submitted
- 10 Sep 2012
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zia Y, Wiener J, Snead MC, Papp J, Phillips C, Flowers L, Medley-Singh N, Costenbader EC, Hylton-Kong T, Kourtis AP. Assessing prevalence of missed laboratory-confirmed sexually transmitted infections among women in Kingston, Jamaica: results from a secondary analysis of the Sino-Implant clinical trial. BMJ Open. 2018 Apr 13;8(4):e019913. doi: 10.1136/bmjopen-2017-019913.
PubMed 29654017Snead MC, Wiener J, Ewumi S, Phillips C, Flowers L, Hylton-Kong T, Medley-Singh N, Legardy-Williams J, Costenbader E, Papp J, Warner L, Black C, Kourtis AP. Prevalence and risk factors associated with STIs among women initiating contraceptive implants in Kingston, Jamaica. Sex Transm Infect. 2017 Nov;93(7):503-507. doi: 10.1136/sextrans-2016-052963. Epub 2017 May 5.
PubMed 28476913Rattray C, Wiener J, Legardy-Williams J, Costenbader E, Pazol K, Medley-Singh N, Snead MC, Steiner MJ, Jamieson DJ, Warner L, Gallo MF, Hylton-Kong T, Kourtis AP. Effects of initiating a contraceptive implant on subsequent condom use: A randomized controlled trial. Contraception. 2015 Dec;92(6):560-6. doi: 10.1016/j.contraception.2015.06.009. Epub 2015 Jun 14.
PubMed 26079469
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica
- ClinicalTrials.gov ID
- NCT01684358
- Acronym / sponsor ID
- SIS / CDC-NCCDPHP-6163
- Keywords
- Prostate-specific antigen, Contraceptive implant, Biological marker, Condoms, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- FHI 360, Ministry of Health, Jamaica, The University of The West Indies
- Study start
- Sep 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant | Experimental | Device: Sino-implant (II)Sino-implant (II) inserted at enrollment visit |
| Delayed implant | Active comparator | Device: Sino-implant (II)Sino-implant (II) inserted at 3-month follow-up visit |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sino-implant (II)Also: Zarin, TRUST, FemplantSino-implant (II) (Shanghai Dahua Pharmaceutical Co, Ltd.; Shanghai, China), a contraceptive implant with two rods each of which contain 75 mg of levonorgestrel. | Device | Delayed implant, Immediate implant |
Primary outcome
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
4 secondary outcomes
Self-reported exposure to semen
Time frame: 3 months
Side effects
Time frame: 3 months
Product discontinuation
Time frame: 3 months
Acceptability
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Derived from this study: PubMed 29654017Zia Y, Wiener J, Snead MC, Papp J, Phillips C, Flowers L, Medley-Singh N, Costenbader EC, Hylton-Kong T, Kourtis AP. Assessing prevalence of missed laboratory-confirmed sexually transmitted infections among women in Kingston, Jamaica: results from a secondary analysis of the Sino-Implant clinical trial. BMJ Open. 2018 Apr 13;8(4):e019913. doi: 10.1136/bmjopen-2017-019913.
- Derived from this study: PubMed 28476913Snead MC, Wiener J, Ewumi S, Phillips C, Flowers L, Hylton-Kong T, Medley-Singh N, Legardy-Williams J, Costenbader E, Papp J, Warner L, Black C, Kourtis AP. Prevalence and risk factors associated with STIs among women initiating contraceptive implants in Kingston, Jamaica. Sex Transm Infect. 2017 Nov;93(7):503-507. doi: 10.1136/sextrans-2016-052963. Epub 2017 May 5.
- Derived from this study: PubMed 26079469Rattray C, Wiener J, Legardy-Williams J, Costenbader E, Pazol K, Medley-Singh N, Snead MC, Steiner MJ, Jamieson DJ, Warner L, Gallo MF, Hylton-Kong T, Kourtis AP. Effects of initiating a contraceptive implant on subsequent condom use: A randomized controlled trial. Contraception. 2015 Dec;92(6):560-6. doi: 10.1016/j.contraception.2015.06.009. Epub 2015 Jun 14.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Rattray, DM study chair
University of West Indies
Elizabeth Costenbader, PhD principal investigator
FHI 360
Athena Kourtis, MD, PhD, MPH principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sino-implant (II) in people with Women Wanting Contraceptive Implant for Pregnancy Prevention, run by Centers for Disease Control and Prevention at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate-specific antigen (PSA) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01684358, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.