- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02197715
Sex and Female Empowerment (SAFE)
13 octobre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
90
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27514
- UNC Horizons
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 40 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
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Expérimental: 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.
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Comparateur actif: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intervention Satisfaction
Délai: The earlier of the completion of the 4 interventions sessions or 6 weeks.
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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.
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The earlier of the completion of the 4 interventions sessions or 6 weeks.
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Contraceptive Consultation Appointment
Délai: The earlier of the completion of the 4 intervention sessions or 6 weeks.
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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.
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The earlier of the completion of the 4 intervention sessions or 6 weeks.
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Intervention Completion
Délai: The earlier of the completion of the 4 interventions sessions or 6 weeks.
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Binary variable: Completes or fails to complete all four intervention sessions in a 6-week period, determined from study records.
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The earlier of the completion of the 4 interventions sessions or 6 weeks.
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Contraceptive Method Effectiveness
Délai: The earlier of the completion of the 4 intervention sessions or 6 weeks.
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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.
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The earlier of the completion of the 4 intervention sessions or 6 weeks.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Knowledge of Reproduction
Délai: Baseline, 1-, 3-, and 6-months post-baseline
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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.
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Baseline, 1-, 3-, and 6-months post-baseline
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Knowledge of Contraceptive Methods
Délai: Baseline, 1-, 3-, 6-months post-baseline
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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.
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Baseline, 1-, 3-, 6-months post-baseline
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Contraceptive Self-efficacy Scale
Délai: Baseline, 1-, 3-, and 6-months post-baseline
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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.
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Baseline, 1-, 3-, and 6-months post-baseline
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Effective Contraceptive Behavior
Délai: Baseline, 1-, 3-, and 6-months post-baseline
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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).
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Baseline, 1-, 3-, and 6-months post-baseline
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Frequency of Use of Barrier Protection in past 30 days
Délai: Baseline, 1-, 3-, and 6-months post-baseline
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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.
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Baseline, 1-, 3-, and 6-months post-baseline
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Number of Times Engaged in Unprotected Sex in past 30 days
Délai: Baseline, 1-, 3-, and 6-months post-baseline
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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.
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Baseline, 1-, 3-, and 6-months post-baseline
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Hendrée E Jones, PhD, University of North Carolina, Chapel Hill
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 août 2014
Achèvement primaire (Réel)
1 août 2017
Achèvement de l'étude (Réel)
1 août 2017
Dates d'inscription aux études
Première soumission
21 juillet 2014
Première soumission répondant aux critères de contrôle qualité
21 juillet 2014
Première publication (Estimation)
23 juillet 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 octobre 2017
Dernière vérification
1 octobre 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13-3075
- R34DA033442 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .