Prospective Cohort Trial To Assess Acceptability and Efficacy of an Adapted STI/HIV Intervention Behavioral Intervention Program in a Population of US Army Personnel and Their Medical Beneficiaries - Execution Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Incident sexually transmitted infections
研究概览
简要总结
The hypothesis is that a behavioral intervention tool adapted for the US military population will be acceptable and associated with a decrease in incident sexually transmitted infection (STI)/HIV rates and high-risk sexual behaviors, and increased self-reported condom use compared to the standard of care at the Joint Base Lewis-McChord (JBLM) Preventive Medicine clinic and the Fort Bragg Department of Public Health (part of Womack Army Medical Center).
详细描述
This is the Execution Phase which will be conducted as a multi-site randomized controlled trial. A previous Formative Phase study was conducted under a separate protocol which has been completed with preliminary data indicating positive outcomes. Participants in both arms will meet the same inclusion/exclusion criteria and will be randomized into the intervention and control arms at a ratio of 1:1.
The intervention arm will receive the KISS (Knocking out Infections through Safer sex and Screening) intervention program in addition to standard STI prevention counselling routinely provided by military medical treatment facilities. The control arm will receive only standard STI prevention counselling. Both arms will receive follow-up educational messages via short message service (SMS)/text messaging monthly for 10 months, and have follow-up study visits at 6 months and 12 months.
The KISS intervention is a 2-hour, small group (6-12 individuals) class-based interactive, educational session based on Social Cognitive Theory and the Theory of Gender and Power. The intervention is an adaptation of the HORIZONS intervention, which has shown efficacy are reducing sexual risk behavior and incident STIs among adolescents in the USA. HORIZONS has been reviewed by the U.S. Centers for Disease Control (CDC) Prevention Synthesis Research team and designated a CDC top-tier (Tier I) evidence-based intervention (EBI).
To enroll in the study, participants must be categorized as "high risk" as determined by a positive test for an STI within the previous 180 days or has had STI screening during this time frame (specifically gonorrhea (GC), chlamydia (CT), M. genitalium, syphilis and/or HIV).
Study subjects will be recruited from Madigan Army Medical Center (Madigan) Preventive Medicine Clinic and the Womack Army Medical Center (Womack) Preventive Medicine Clinic in Ft. Bragg, North Carolina (NC). In addition, promotional flyers for recruitment will be placed in public areas on both bases, and will be promoted through approved social media channels. Subjects may also refer up to 5 friends or colleagues for screening.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 30 years
- •Army active duty or Army medical beneficiary
- •Eligible to receive care at a military healthcare clinic for at least 12 months from enrollment
- •HIV negative
- •Not scheduled for military deployment or transfer within 3 months of enrolment
- •Not pregnant, regardless of marital status
- •Not trying to become pregnant or impregnate a partner, regardless of marital status
- •Be classified as "high risk" either through a positive STI diagnosis in the last 180 days or has had STI screening during this timeframe.
- •Self reports vaginal, oral, and/or anal sexual contact in the last 30 days.
排除标准
- •Under 18 or over 30 years of age
- •Not Army active duty or Army medical beneficiary
- •Not eligible to receive care at a military healthcare clinic for study duration (next 12 months)
- •HIV positive
- •Military deployment or transfer scheduled within 3 months of enrollment
- •Are pregnant, regardless of marital status
- •Are trying to become pregnant or impregnate someone, regardless of marital status
- •Has not had a positive STI diagnosis or STI screening within the last 180 days
- •Does not self-report vaginal, anal, and/or oral sexual contact in the last 30 days
研究组 & 干预措施
Control Arm
Control Arm will will complete a total of three visits:
Visit 1 (Day 1): Recruitment/Baseline Biological Testing, if needed; completion of baseline study surveys including Knowledge Assessment
Monthly: Prevention Maintenance Intervention Messages from months 2-11
Visit 3 (Day 180): 6 Month Follow-up biological testing and study survey
Visit 4 (Day 365): 12 Month Follow-up biological testing and study surveys
Intervention Arm
Intervention Arm will will complete a total of four visits:
Visit 1 (Day 1): Recruitment/Baseline Biological Testing, if needed; completion of baseline study surveys including Knowledge Assessment
Visit 2 (Day 2-30): Group Intervention Session, Feedback form, and post-intervention knowledge assessment (for intervention arm only)
Monthly: Prevention Maintenance Intervention Messages from months 2-11
Visit 3 (Day 180): 6 Month Follow-up biological testing and study survey
Visit 4 (Day 365): 12 Month Follow-up biological testing and study surveys
干预措施: STI/HIV Intervention Behavioral Intervention Program (Behavioral)
结局指标
主要结局
Incident sexually transmitted infections
时间窗: 12 months
Biological testing for syphilis, chlamydia trachomatis, neisseria gonorrhea, mycoplasma genitalium, and HIV
Acceptability of the intervention
时间窗: immediately after the intervention
participant feedback and rating of the intervention session
次要结局
- Proportion of sexual encounters protect by condom use(12 months)
- Number of sexual partners(12 months)