- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02197715
Sex and Female Empowerment (SAFE)
13. oktober 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27514
- UNC Horizons
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 40 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Intervention Satisfaction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Knowledge of Reproduction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hendrée E Jones, PhD, University of North Carolina, Chapel Hill
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2014
Primær fullføring (Faktiske)
1. august 2017
Studiet fullført (Faktiske)
1. august 2017
Datoer for studieregistrering
Først innsendt
21. juli 2014
Først innsendt som oppfylte QC-kriteriene
21. juli 2014
Først lagt ut (Anslag)
23. juli 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13-3075
- R34DA033442 (U.S. NIH-stipend/kontrakt)
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