Sex and Female Empowerment

NCT02197715 | Completed DMC

• 2 other identifiers: 13-3075R34DA033442
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

Pregnancy; Contraceptive Methods; Family Planning Services

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (6)

• 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

• 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

Study Arms (3)

computer-adaptive SAFE

EXPERIMENTAL

Computer-adaptive SAFE will consist of 4 60-minute sessions. Sessions 1 and 2 will explore participants' reasons to become and rewards for becoming pregnant/having children or avoiding it, introduce reproductive biology in the context of different contraceptive methods and explore the participant's ambivalence toward using different contraceptive methods. Session 3 will provide in-depth coverage of contraceptive methods and the need for use of a barrier method. Session 4 will focus on effective strategies to communicate with a sexual partner. Computer-adaptive SAFE will use an audio computer-assisted self-interviewing (ACASI) format.

Behavioral: Computer-adaptive SAFE

Face-to-face SAFE

EXPERIMENTAL

Face-to-face SAFE will consist of 4 60-minute sessions using motivational interviewing techniques. Each session will be led by an experienced counselor. Sessions 1 and 2 will explore participants' reasons to become and rewards for becoming pregnant/having children or avoiding it, introduce reproductive biology in the context of different contraceptive methods and explore the participant's ambivalence toward using different contraceptive methods. Session 3 will provide in-depth coverage of contraceptive methods and the need for use of a barrier method, and relevant skills regarding how to use and negotiate use of contraceptive methods. Session 4 will focus on effective strategies to communicate with a sexual partner.

Behavioral: Face-to-face SAFE

Usual Care

ACTIVE COMPARATOR

Usual care comprises four 60-minute provider-led individual care sessions about HIV, STIs, and their risks, as well as prevention methods. Contraceptive methods are discussed within this context. There will be no demand on participants to attend these sessions. Participants will receive written take-home materials to review on their own and/or with their sex partners.

Behavioral: Usual Care

Interventions

Computer-adaptive SAFE BEHAVIORAL

computer-adaptive SAFE

Face-to-face SAFE BEHAVIORAL

Face-to-face SAFE

Usual Care BEHAVIORAL

Usual Care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18-40 years old for women;
• able to provide informed consent;
• currently enrolled in a opioid-agonist-maintenance program;
• currently not pregnant (urine testing confirmation);
• report heterosexual orientation;
• no tubal ligation or other sterilization;
• no plans to become pregnant in the next 6 months; and
• provides verifiable locator information.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UNC Horizons

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Hendrée E Jones, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

US (1)