Improving Women's Sexual Health While in Drug Addiction Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid Use Disorder
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Contraceptive Consultation Appointment
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study will develop and initially evaluate Sex and Female Empowerment (SAFE), an intervention designed to increase acceptance of and adherence to contraceptive practices among opioid-agonist-maintained women of childbearing age. The intervention will be delivered in one of two formats: a face-to-face brief intervention approach or a novel computer-adaptive platform. To the extent that either version of SAFE is found to be efficacious compared with usual care, it has the potential to reduce the number of unintended pregnancies and consequently decrease the need for and the costs of child protective services.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Contraceptive Consultation Appointment
Time Frame: The earlier of the completion of the 4 intervention sessions or 6 weeks.
Binary variable: Did or did not the participant schedule and attend an appointment with a obstetrical provider at University of North Carolina at Chapel Hill Obstetrical/Gynecological Services, determined from medical records.
Intervention Satisfaction
Time Frame: The earlier of the completion of the 4 interventions sessions or 6 weeks.
Summary scale score: Derived from responses to a four-item 5-point Likert-type scale (1 = "not at all help" to 5 = "extremely helpful") of satisfaction with the intervention, administered at the end of each of the four intervention sessions.
Contraceptive Method Effectiveness
Time Frame: The earlier of the completion of the 4 intervention sessions or 6 weeks.
Percentage: The typical use effectiveness level of the contraceptive method in use at the end of the intervention based on responses to the National Survey of Family Growth contraceptive methods items. If the participant does not make an appointment and choose a contraceptive method, the typical-use effectiveness level of the contraceptive method indicated at intake in response to the Survey of Family Growth contraceptive methods items will be used. Typical effectiveness rating of contraceptive methods is a percentage between 15% and 99.85%, and will be based on Hatcher, R.A., Contraceptive technology, which reports success and failure rates for contraceptive methods in current use.
Intervention Completion
Time Frame: The earlier of the completion of the 4 interventions sessions or 6 weeks.
Binary variable: Completes or fails to complete all four intervention sessions in a 6-week period, determined from study records.
Secondary Outcomes
- Knowledge of Reproduction(Baseline, 1-, 3-, and 6-months post-baseline)
- Knowledge of Contraceptive Methods(Baseline, 1-, 3-, 6-months post-baseline)
- Contraceptive Self-efficacy Scale(Baseline, 1-, 3-, and 6-months post-baseline)
- Number of Times Engaged in Unprotected Sex in past 30 days(Baseline, 1-, 3-, and 6-months post-baseline)
- Effective Contraceptive Behavior(Baseline, 1-, 3-, and 6-months post-baseline)
- Frequency of Use of Barrier Protection in past 30 days(Baseline, 1-, 3-, and 6-months post-baseline)