Pregnancy, Sexually Transmitted Infections
Conditions
Keywords
Pregnancy, STI prevention, adolescents, probation
Brief summary
The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population.
Detailed description
This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for at-risk youth for both those who do and do not want a pregnancy. Those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island to provide reproductive health services in the community. The investigators will recruit 250 at risk youth from RI Juvenile Probation Department (JPD), RI group homes and alternative schools, Job Corps of Rhode Island, and Community Mental Health Centers and randomize them to two interventions: two sessions of personalized MI or two sessions of Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI is based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. ASH provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.
Interventions
BEHAVIORALMotivational Intervention
There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.
BEHAVIORALDidactic Educational Intervention
There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Brown University
University of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\) Age 14-21; * 2\) Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months; * 3\) Willing to comply with protocol, follow-up assessments, and provide at least one locator; and * 4\) Fluent in English.
Exclusion criteria
* 1\) Inability to give informed consent secondary to organic brain dysfunction, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that preclude participation in assessment or counseling); * 2\) Girls who are not sexually active; or * 3\) Currently pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. | 9 month follow-up | Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective. |
| Number of Participants With a Positive STI Test After A Baseline Negative Test. | 9 month follow-up | Conducted STI testing for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection. |
| Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months. | 9 month follow up | Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Positive Pregnancy Test After Baseline Assessment | 9 month follow up | The secondary outcome is pregnancy as documented by a positive pregnancy test by at follow-up visit. Pregnancy tests were administered by urine collection and Home Pregnancy Test sticks. |
| Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs. | 9 month follow up | Using the Timeline Followback (TLFB): Condom use was measured via a calendar recall for both interventions. Participants indicate whether or not condoms were used each time sex was reported. |
| Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex. | 9 month follow-up | Using the Timeline Follow-back (TLFB): Condom and substance use were measured via a calendar recall for both interventions. Participants indicate whether or not condoms and substances were used each time sex was reported. |
Countries
United States
Participant flow
Recruitment details
This project enrolled 272 at-risk females aged 14-21. Participants were eligible if they had sexual intercourse with a male partner in the past four months, were not pregnant and intended to have intercourse with a male in the next 6 months. Recruitment began in February of 2013 and the last participant was recruited in August of 2017.
Participants by arm
| Arm | Count |
|---|---|
| Motivational Intervention There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up.
Motivational Intervention: There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up. | 142 |
| Didactic Educational Intervention There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up.
Didactic Educational Intervention: There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up. | 130 |
| Total | 272 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 13 |
| Overall Study | Withdrawal by Subject | 8 | 5 |
Baseline characteristics
| Characteristic | Motivational Intervention | Total | Didactic Educational Intervention |
|---|---|---|---|
| Age, Continuous | 16.97 years STANDARD_DEVIATION 1.71 | 16.98 years STANDARD_DEVIATION 1.7 | 16.99 years STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 69 Participants | 120 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 152 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 58 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 52 Participants | 92 Participants | 40 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 15 Participants | 6 Participants |
| Race (NIH/OMB) White | 48 Participants | 95 Participants | 47 Participants |
| Region of Enrollment United States | 142 participants | 272 participants | 130 participants |
| Sex: Female, Male Female | 142 Participants | 272 Participants | 130 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 142 | 0 / 130 |
| other Total, other adverse events | 0 / 142 | 0 / 130 |
| serious Total, serious adverse events | 0 / 142 | 0 / 130 |
Outcome results
Primary
Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.
Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months.
Time frame: 9 month follow up
Population: Analysis conducted on participants who initiated highly effective contraceptive use post treatment intervention. Those who initiated highly effective contraceptives at baseline (pre treatment) were not included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Intervention | Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months. | 61 Participants |
| Didactic Educational Intervention | Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months. | 51 Participants |
Primary
Number of Participants With a Positive STI Test After A Baseline Negative Test.
Conducted STI testing for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection.
Time frame: 9 month follow-up
Population: Analysis conducted on all participants who provided a urine sample at baseline. 1 participant refused.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Intervention | Number of Participants With a Positive STI Test After A Baseline Negative Test. | 18 Participants |
| Didactic Educational Intervention | Number of Participants With a Positive STI Test After A Baseline Negative Test. | 13 Participants |
Primary
Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.
Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective.
Time frame: 9 month follow-up
Population: Continuous use of highly effective birth control is defined as those who are using effective birth control for 6 months or more. Thus this analysis only includes participants who initiated effective birth control for at least 6 months of data collection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Intervention | Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. | 39 Participants |
| Didactic Educational Intervention | Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. | 29 Participants |
p-value: >0.0595% CI: [0.056, 1.42]Chi-squared, Corrected
Secondary
Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.
Using the Timeline Follow-back (TLFB): Condom and substance use were measured via a calendar recall for both interventions. Participants indicate whether or not condoms and substances were used each time sex was reported.
Time frame: 9 month follow-up
Secondary
Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.
Using the Timeline Followback (TLFB): Condom use was measured via a calendar recall for both interventions. Participants indicate whether or not condoms were used each time sex was reported.
Time frame: 9 month follow up
Secondary
Number of Participants With a Positive Pregnancy Test After Baseline Assessment
The secondary outcome is pregnancy as documented by a positive pregnancy test by at follow-up visit. Pregnancy tests were administered by urine collection and Home Pregnancy Test sticks.
Time frame: 9 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Intervention | Number of Participants With a Positive Pregnancy Test After Baseline Assessment | 6 Participants |
| Didactic Educational Intervention | Number of Participants With a Positive Pregnancy Test After Baseline Assessment | 10 Participants |