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Sex and Female Empowerment (SAFE)

2017年10月13日 更新者:University of North Carolina, Chapel Hill

Improving Women's Sexual Health While in Drug Addiction Treatment

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.

調査の概要

研究の種類

介入

入学 (実際)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27514
        • UNC Horizons

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~40年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
実験的: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Intervention Satisfaction
時間枠: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.
The earlier of the completion of the 4 interventions sessions or 6 weeks.
Contraceptive Consultation Appointment
時間枠: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.
The earlier of the completion of the 4 intervention sessions or 6 weeks.
Intervention Completion
時間枠: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.
The earlier of the completion of the 4 interventions sessions or 6 weeks.
Contraceptive Method Effectiveness
時間枠: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.
The earlier of the completion of the 4 intervention sessions or 6 weeks.

二次結果の測定

結果測定
メジャーの説明
時間枠
Knowledge of Reproduction
時間枠: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.
Baseline, 1-, 3-, and 6-months post-baseline
Knowledge of Contraceptive Methods
時間枠: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.
Baseline, 1-, 3-, 6-months post-baseline
Contraceptive Self-efficacy Scale
時間枠: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.
Baseline, 1-, 3-, and 6-months post-baseline
Effective Contraceptive Behavior
時間枠: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).
Baseline, 1-, 3-, and 6-months post-baseline
Frequency of Use of Barrier Protection in past 30 days
時間枠: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.
Baseline, 1-, 3-, and 6-months post-baseline
Number of Times Engaged in Unprotected Sex in past 30 days
時間枠: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.
Baseline, 1-, 3-, and 6-months post-baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Hendrée E Jones, PhD、University of North Carolina, Chapel Hill

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年8月1日

一次修了 (実際)

2017年8月1日

研究の完了 (実際)

2017年8月1日

試験登録日

最初に提出

2014年7月21日

QC基準を満たした最初の提出物

2014年7月21日

最初の投稿 (見積もり)

2014年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2017年10月17日

QC基準を満たした最後の更新が送信されました

2017年10月13日

最終確認日

2017年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 13-3075
  • R34DA033442 (米国 NIH グラント/契約)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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