Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,215
- 试验地点
- 3
- 主要终点
- Intervention Uptake (acceptability) and Coverage (feasibility)
研究概览
简要总结
MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a gender-specific combination HIV prevention package for youth (aged 15-24) in high burden settings. The study aims to pilot a combination package of gender-specific interventions in western Kenya in a mobile health delivery format using integrated services delivery.
详细描述
The MP3-Youth study will provide critical information for design and evaluation of combination HIV prevention intervention packages that are sensitive to gender-specific risks among this most-at-risk population in high-HIV burden African settings. Our team of biobehavioral and clinical scientists, mathematical modelers, and trial design specialists will:
Aim 1: Identify gender (sex)-specific drivers of HIV acquisition risk, including pregnancy among females, for youth in sub-Saharan Africa, and interventions to best address those risks.
Aim 2: Conduct mathematical modeling to select optimal combination intervention package components and to assess potential population-level impact.
Aim 3: In partnership with a highly-productive nongovernmental organization (NGO) that is delivering PEPFAR-funded HIV prevention services, develop and pilot a combination HIV prevention package specific for female and for male youth - 'MP3-Youth' - in Nyanza Province, Kenya.
Aim 4: Design a phase IV study protocol for testing the effectiveness of a gender-specific youth HIV prevention package in sub-Saharan Africa. We will disseminate these research protocol recommendations, and study instruments including the mathematical modeling tool, as a combination prevention intervention research toolkit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any male or female between the ages of 15-
- •Able to understand spoken English or Kiswahili or Dholuo.
- •Willing to give informed consent or if younger than 18 years of age has a parent or guardian willing to provide consent in addition to the minor's assent
- •Willing to be tested for HIV.
- •Willing to get participant ID based on biometric finger scan.
排除标准
- •Any male or female younger than 15 or older than
- •Unable to understand spoken English, or Kiswahili or Dholuo.
- •If under 18 and not an emancipated minor, unable to get parental consent.
研究组 & 干预措施
Male-Specific Intervention Package
Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm.
干预措施: Male-Specific Intervention Package (Other)
Female-Specific Intervention Package
Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm.
干预措施: Female-Specific Intervention Package (Other)
Pre-Exposure Prophylaxis (Females)
PrEP adherence and feasibility. Longitudinal Arm.
干预措施: Pre-Exposure Prophylaxis (Females) (Drug)
Cash Transfer Cohort (Females)
School attendance, behavioral data, and feasibility. Longitudinal Arm
干预措施: Cash Transfer Cohort (Females) (Behavioral)
结局指标
主要结局
Intervention Uptake (acceptability) and Coverage (feasibility)
时间窗: 6 months
* Coverage: The proportion of youth in the community who attend each mobile event (estimated from youth population denominator) * Enrollment: The number of participants who consent to being enrolled in the study during each mobile event. * Uptake: The number of participants who choose one or more components of their tailored combination package (and which components). * Intervention Acceptability: Satisfaction with mobile event services
次要结局
- Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months(12 months)