Opioid Use Disorder
Conditions
Keywords
Pregnancy, Contraceptive Methods, Family Planning Services
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.
Interventions
BEHAVIORALComputer-adaptive SAFE
BEHAVIORALFace-to-face SAFE
BEHAVIORALUsual Care
Sponsors
National Institute on Drug Abuse (NIDA)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Satisfaction | 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 Consultation Appointment | 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 Completion | 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. |
| Contraceptive Method Effectiveness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Use of Barrier Protection in past 30 days | Baseline, 1-, 3-, and 6-months post-baseline | 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. |
| Knowledge of Reproduction | Baseline, 1-, 3-, and 6-months post-baseline | 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. |
| Number of Times Engaged in Unprotected Sex in past 30 days | Baseline, 1-, 3-, and 6-months post-baseline | 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. |
| Knowledge of Contraceptive Methods | Baseline, 1-, 3-, 6-months post-baseline | 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. |
| Contraceptive Self-efficacy Scale | Baseline, 1-, 3-, and 6-months post-baseline | 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. |
| Effective Contraceptive Behavior | Baseline, 1-, 3-, and 6-months post-baseline | 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). |
Countries
United States
Outcome results
None listed