Sex and Female Empowerment

Opioid Use Disorder Clinical Trial

— SAFE  

Official title:

Improving Women's Sexual Health While in Drug Addiction Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197715
• Other study ID #: 13-3075
• Secondary ID: R34DA033442
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: October 13, 2017
• Start date: August 2014
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion criteria will be:

1. ages 18-40 years old for women;

2. able to provide informed consent;

3. currently enrolled in a opioid-agonist-maintenance program;

4. currently not pregnant (urine testing confirmation);

5. report heterosexual orientation;

6. no tubal ligation or other sterilization;

7. no plans to become pregnant in the next 6 months; and

8. provides verifiable locator information.

Related Conditions & MeSH terms

• Opioid Use Disorder

Intervention

Behavioral:
• Computer-adaptive SAFE

• Face-to-face SAFE

• Usual Care

Locations

Country	Name	City	State
United States	UNC Horizons	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Satisfaction	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.	The earlier of the completion of the 4 interventions sessions or 6 weeks.
Primary	Contraceptive Consultation Appointment	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.	The earlier of the completion of the 4 intervention sessions or 6 weeks.
Primary	Intervention Completion	Binary variable: Completes or fails to complete all four intervention sessions in a 6-week period, determined from study records.	The earlier of the completion of the 4 interventions sessions or 6 weeks.
Primary	Contraceptive Method Effectiveness	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.	The earlier of the completion of the 4 intervention sessions or 6 weeks.
Secondary	Knowledge of Reproduction	Summary scale score: Derived from eight true-false questions about participants' understanding of the information that was presented in the four intervention sessions about anatomy, menstruation, fertility, and conception, administered at each assessment time point.	Baseline, 1-, 3-, and 6-months post-baseline
Secondary	Knowledge of Contraceptive Methods	Summary scale score: Derived from twenty true-false questions about participants' understanding of the information presented in the four intervention sessions about contraceptive methods, how hormonal contraceptives work, how to correctly use them; hormonal contraceptive side effects and ways to deal with them; which methods are effective against STIs/HIV; correct condom use, administered at each assessment time point.	Baseline, 1-, 3-, 6-months post-baseline
Secondary	Contraceptive Self-efficacy Scale	Summary scale score: Derived from the Contraceptive Self-efficacy Scale, an eighteen-item 5-point Likert-type scale (1 = "not at all true of me" and 5 = "completely true of me") designed to measure a female respondent's motivational barriers to effective contraceptive use, including obtaining contraceptives, using contraceptives with a partner, talking to a partner about contraceptive use, using contraceptives despite partner approval, and preventing unprotected sexual intercourse, administered at each assessment time point.	Baseline, 1-, 3-, and 6-months post-baseline
Secondary	Effective Contraceptive Behavior	Ordered polytomous variable: Participant's self-report of their contraceptive behavior obtained at each assessment time point will be classified into 1 of 4 patterns: (1) "uninterrupted effective user" (e.g., implant, injectable, an IUD); (2) "uninterrupted other user" (use of effective methods on an interrupted basis); (3) "sporadic user" (use of some method when at risk for pregnancy); or (4) "nonuser", where "uninterrupted" in (1) means that an effective method was used for the entire time period under assessment; otherwise, categorized as (2).	Baseline, 1-, 3-, and 6-months post-baseline
Secondary	Frequency of Use of Barrier Protection in past 30 days	Count variable: Self-reported number of times in the past 30 days a participant used a barrier method for protection from HIV/STIs when engaging in sexual activities, collected at each assessment time point.	Baseline, 1-, 3-, and 6-months post-baseline
Secondary	Number of Times Engaged in Unprotected Sex in past 30 days	Count variable: Self-reported number of times in the past 30 days a participant engaged in unprotected vaginal, oral, or anal sex, collected at each assessment time point.	Baseline, 1-, 3-, and 6-months post-baseline