HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Presence of Trichomoniasis
研究概览
简要总结
The pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, of delivering the enhanced Women's Coop and nutrition control interventions. Per recent guidance from NIMH, the investigators will also examine 95% confidence intervals around differences between the proposed intervention and a dose-matched control condition (Nutrition Program), for the following outcomes through 8 months post prison release: reduced unprotected vaginal or anal sex occasions and fewer cases of vaginal trichomoniasis (primary); reduced interpersonal violence episodes, symptoms of PTSD and depression, and drug using/heavy drinking days (secondary); and increased affect management and social support (including effectiveness in obtaining substance use, mental health treatment and other resources) (tertiary).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females in prison
- •Experienced lifetime interpersonal violence (includes physical or sexual assault or abuse)
- •At least one unprotected sexual occasion with a male partner within the 90 days prior to incarceration
- •Approximately 6-10 weeks before release
- •Expect to be released to locations within RI or MA
- •Exclusion criteria:
- •Cannot complete intake interview due to problems with reality testing, brain impairment, or language barrier
排除标准
- 未提供
结局指标
主要结局
Presence of Trichomoniasis
时间窗: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
The investigators will calculate odds ratios and 95% confidence intervals for any positive trichomoniasis test during follow-up using logistic regression, with baseline trichomoniasis status as a covariate. The presence of Trichomoniasis is measured by rapid test.
Treatment Feasibility
时间窗: 2 months post release
One of the primary goals of a treatment development study is to demonstrate the feasibility of the proposed treatment and of the study and recruitment methods. As a result, the investigators will assess the feasibility of the research procedures by examining study recruitment and refusal rates, participants' willingness to be randomized, follow-up rates, reliability and range of responses to study questionnaires, and success of the interventionist training program
Number of Unprotected Sexual Occasions (USOs; Vaginal and Anal)
时间窗: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
The investigators will calculate effect sizes and confidence intervals for number of USOs. The number of USOs will be measured by the Timeline Follow Back (TLFB).
Treatment Acceptability
时间窗: 2 months post release
The investigators will assess the feasibility and acceptability of WPC and NP by examining rates of treatment attendance, rates of treatment completion (attending at least 5 of the 6 scheduled individual sessions) and drop-out, and scores on the End of Treatment Questionnaire. Additionally, they will examine reasons for termination for consistent patterns. Acceptability of both WPC and NP using data from Client Satisfaction Questionnaire and detailed exit interviews will be examined.
次要结局
- PTSD Symptom Severity(Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release)
- Interpersonal violence (IPV) episodes(Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release)
- Post Release Drug Using/Heavy Drinking Days(Slope over time: 2 months after release, 5 months after release, 8 months after release)
- Depressive Symptom Severity(Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release)
研究者
Dr. Jennifer Johnson
Associate Professor (Research)
Brown University