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Sex and Female Empowerment (SAFE)

13 ottobre 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27514
        • UNC Horizons

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 40 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Computer-adaptive SAFE
Sperimentale: 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.
Comportamentale: Face-to-face SAFE
Comparatore attivo: 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.
Comportamentale: Solita cura

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intervention Satisfaction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Knowledge of Reproduction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Collaboratori

National Institute on Drug Abuse (NIDA)

Investigatori

  • Investigatore principale: Hendrée E Jones, PhD, University of North Carolina, Chapel Hill

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2014

Completamento primario (Effettivo)

1 agosto 2017

Completamento dello studio (Effettivo)

1 agosto 2017

Date di iscrizione allo studio

Primo inviato

21 luglio 2014

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2014

Primo Inserito (Stima)

23 luglio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 ottobre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 ottobre 2017

Ultimo verificato

1 ottobre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 13-3075
  • R34DA033442 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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