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- Klinische proef NCT02197715
Sex and Female Empowerment (SAFE)
13 oktober 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
90
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27514
- UNC Horizons
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 40 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Intervention Satisfaction
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Knowledge of Reproduction
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Hendrée E Jones, PhD, University of North Carolina, Chapel Hill
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 augustus 2014
Primaire voltooiing (Werkelijk)
1 augustus 2017
Studie voltooiing (Werkelijk)
1 augustus 2017
Studieregistratiedata
Eerst ingediend
21 juli 2014
Eerst ingediend dat voldeed aan de QC-criteria
21 juli 2014
Eerst geplaatst (Schatting)
23 juli 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 oktober 2017
Laatste update ingediend die voldeed aan QC-criteria
13 oktober 2017
Laatst geverifieerd
1 oktober 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13-3075
- R34DA033442 (Subsidie/contract van de Amerikaanse NIH)
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