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

Not Applicable

Completed

• Conditions: Women Wanting Contraceptive Implant for Pregnancy Prevention
• Interventions: Device: Sino-implant (II)

• Registration Number: NCT01684358
• Lead Sponsor: Centers for Disease Control and Prevention

Brief 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-13
• Status Verified: 2013-04
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 414

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate implant	Sino-implant (II)	Sino-implant (II) inserted at enrollment visit
Delayed implant	Sino-implant (II)	Sino-implant (II) inserted at 3-month follow-up visit

Primary Outcome Measures

Name	Time	Method
Prostate-specific antigen (PSA)	3 months	Number of women with recent exposure to semen as measured by the detection of prostate-specific antigen (PSA) in vaginal swabs

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Epidemiology Research Training Unit; 🇯🇲 Kingston, Jamaica