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

Women Wanting Contraceptive Implant for Pregnancy Prevention Clinical Trial

— SIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684358
• Other study ID #: CDC-NCCDPHP-6163
• Status: Completed
• Phase: N/A
• First received: September 10, 2012
• Last updated: November 4, 2014
• Start date: September 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2013
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentJamaica: Ministry of HealthJamaica: University of Hospital of the West Indies,The University of the West Indies Mona Campus, Faculty of Medical Sciences Ethics Committee
• Study type: Interventional

Clinical 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 follow-up visit.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Women Wanting Contraceptive Implant for Pregnancy Prevention

Intervention

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.

Locations

Country	Name	City	State
Jamaica	Epidemiology Research Training Unit	Kingston

Sponsors (4)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	FHI 360, Ministry of Health, Jamaica, The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months	No
Secondary	Self-reported exposure to semen	Number of women reporting recent exposure to semen	3 months	No
Secondary	Side effects	Number of women with side effects, including changes in menstrual bleeding patterns, and mean change in body weight	3 months	Yes
Secondary	Product discontinuation	Number of women in the immediate implant arm who discontinue implant use during the study	3 months	No
Secondary	Acceptability	Number of women in the immediate implant arm who perceive the implant as acceptable	3 months	No