Sex and Female Empowerment (SAFE)

University of North Carolina (UNC)

Status: Completed

Conditions: Opioid Use Disorder

Treatments: Behavioral: Usual Care; Behavioral: Face-to-face SAFE; Behavioral: Computer-adaptive SAFE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02197715

R34DA033442 (U.S. NIH Grant/Contract)

13-3075

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

computer-adaptive SAFE

Experimental group

Description:

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.

Treatment:

Behavioral: Computer-adaptive SAFE

Face-to-face SAFE

Experimental group

Description:

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.

Treatment:

Behavioral: Face-to-face SAFE

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care