Improving HIV Prevention and Substance Use Post-Sexual Assault Services for Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Retention of the intervention group as measured by the number of participants that completed the one month follow-up survey
研究概览
简要总结
The purpose of this study is to tailor existing sexual assault nurse examiner (SANE) services with same-day HIV prophylaxis and substance use screening, brief intervention, or referral using semi-structured adolescents and young adults (AYA) survivor and key informant interviews, and iterative co-design/pilot testing of adapted strategies with the youth working group (YWG), to optimize study mechanisms and outcome measures using cognitive interviews, analysis of community partner data, and recruitment and retention strategies with the youth working group (YWG) and community advisory board (CAB), to conduct a pilot randomized controlled trial with 40 AYA to test feasibility, acceptability, and initial efficacy compared to usual care, to evaluate recruitment, randomization, and follow-up strategies; adherence to intervention dose; retention benchmarks; and acceptability and to evaluate preliminary efficacy of outcome measures (uptake of post-assault HIV prevention and substance use treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data collectors will be blinded
入排标准
- 年龄范围
- 17 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •experienced a sexual assault within the last 72 hours
- •speak English
- •not planning to move out of the metro area during the study.
排除标准
- •noticeably intoxicated or under the influence
- •are overtly having severe, untreated mental illness symptoms
研究组 & 干预措施
Enhanced intervention
干预措施: Enhanced intervention (Behavioral)
Usual Care
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Retention of the intervention group as measured by the number of participants that completed the one month follow-up survey
时间窗: end of study (1 month after baseline)
Retention of the control group as measured by the number of participants that completed the one month follow-up survey
时间窗: end of study (1 month after baseline)
Acceptability as measured by score on the credibility/expectancy questionnaire
时间窗: end of study (1 month after baseline)
The Credibility and Expectancy Questionnaire (CEQ) was used to assess the acceptability of the intervention. All participants completed both subscales: the credibility subscale and the expectancy subscale. Each subscale total score ranges from 0 to 10, with higher scores indicating greater perceived acceptability. The expectancy subscale is reported.
Adherence to intervention as measured by percentage of content completed in the fidelity checklist
时间窗: end of study (1 month after baseline)
Acceptability as measured by percentage of data loss
时间窗: end of study (1 month after baseline)
Recruitment feasibility as measured by percentage of eligible individuals screened
时间窗: end of study (1 month after baseline)
Recruitment feasibility as measured by percentage of eligible individuals enrolled
时间窗: end of study (1 month after baseline)
Recruitment feasibility as measured by time delay from screening to enrollment
时间窗: end of study (1 month after baseline)
Recruitment feasibility as measured by time to enroll sufficient sample size
时间窗: end of study (1 month after baseline)
Recruitment feasibility as measured by percentage loss to exclusion criteria.
时间窗: end of study (1 month after baseline)
Randomization strategies as measured by proportion randomized to intervention and control
时间窗: end of study (1 month after baseline)
Retention as measured by the number of participants that completed the one month follow-up survey
时间窗: end of study (1 month after baseline)
次要结局
- Uptake of substance use treatment as self reported as reported on the self report questionnaire(1-month follow-up)
- Uptake of post-assault HIV prevention as measured by self report of nPEP uptake(1-month follow-up)
- Uptake of post-assault HIV prevention as measured by self report of Doxycycline Post-Exposure Prophylaxis (DoxyPEP) uptake(1-month follow-up)
- Adherence of non-occupational Post-Exposure Prophylaxis (nPEP) as reported on the self report questionnaire(1-month follow-up)
- Adherence of substance use treatment as reported on the self report questionnaire(1-month follow-up)
研究者
Diane Santa Maria
Professor
The University of Texas Health Science Center, Houston