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Completed

NCT Number: NCT02197715

Sex and Female Empowerment

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Horizons

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

will be:

  • 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.

Treatment and study plan

Computer-adaptive SAFE

Behavioral

Face-to-face SAFE

Behavioral

Usual Care

Behavioral

Primary outcomes

  1. Intervention Satisfaction

    Time frame: 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.

  2. Contraceptive Consultation Appointment

    Time frame: 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.

  3. Intervention Completion

    Time frame: 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.

  4. Contraceptive Method Effectiveness

    Time frame: 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 outcomes

  1. Knowledge of Reproduction

    Time frame: 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.

  2. Knowledge of Contraceptive Methods

    Time frame: 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.

  3. Contraceptive Self-efficacy Scale

    Time frame: 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.

  4. Effective Contraceptive Behavior

    Time frame: 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).

  5. Frequency of Use of Barrier Protection in past 30 days

    Time frame: 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.

  6. Number of Times Engaged in Unprotected Sex in past 30 days

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Improving Women's Sexual Health While in Drug Addiction Treatment

Acronym: SAFE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 23, 2014
Registry last updated
Oct 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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