Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2014-08-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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computer-adaptive SAFE
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.
Computer-adaptive SAFE
Face-to-face SAFE
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.
Face-to-face SAFE
Usual Care
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.
Usual Care
Interventions
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Computer-adaptive SAFE
Face-to-face SAFE
Usual Care
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
40 Years
FEMALE
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Hendrée E Jones, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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UNC Horizons
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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13-3075
Identifier Type: -
Identifier Source: org_study_id