- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02197715
Sex and Female Empowerment (SAFE)
13 de outubro de 2017 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
90
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- UNC Horizons
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 40 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Intervention Satisfaction
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Knowledge of Reproduction
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hendrée E Jones, PhD, University of North Carolina, Chapel Hill
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de agosto de 2014
Conclusão Primária (Real)
1 de agosto de 2017
Conclusão do estudo (Real)
1 de agosto de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de julho de 2014
Primeira postagem (Estimativa)
23 de julho de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de outubro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de outubro de 2017
Última verificação
1 de outubro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 13-3075
- R34DA033442 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .