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临床试验/NCT03410225
NCT03410225已完成不适用

Computer-Assisted Motivational Interviewing Intervention to Facilitate Teen Pregnancy Prevention and Fitness Behavior Changes: A Randomized Trial for Young Men

Columbia University3 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
3
主要终点
Change in number of participants that had sexual intercourse without using a condom since the last assessment Condom use at last sex

研究概览

简要总结

The present study aims to test and rigorously evaluate the effectiveness of a computer-assisted motivational interviewing (CAMI) intervention that has already been shown to be successful with young women by reducing the risk of rapid subsequent birth among adolescent mothers, and applying this intervention to young men.

The purpose of the intervention is to increase condom use, increase female partner use of moderately or highly effective contraception, and increase completion of a reproductive health visit and STI/HIV testing.

The primary hypothesis is that the CAMI-TPP (CAMI aimed at Teen Pregnancy Prevention) intervention will increase the proportion of participants who do not engage in risky sex, report condom use at last intercourse as well as partner use of contraception compared to those in the Fitness group. It is also predicted that young men who receive the CAMI-TPP will report higher completion of a reproductive health service visit with sexually transmitted infection (STI) testing over the course of study participation compared to those in the CAMI-Fitness (CAMI aimed at healthy diet, physical activity and tobacco avoidance) group.

详细描述

Most teen pregnancies (82%) in the United States are unintended. Actively engaging young men in preventing teen pregnancy is a necessary and central component to effecting change. Young men, aged 15-19 and 20-24 years, father most of the children born to teen mothers. Few interventions have been designed specifically or shown to be effective for young men in reducing teen pregnancy.

Counseling and feedback based on Motivational Interviewing (MI) principles demonstrated greater success than standard, didactic advice in several domains of behavior change. The effectiveness of this type of counseling to alter young men's sexual and contraceptive behaviors has not been rigorously evaluated.

Participants will be randomly chosen (like flipping a coin) to take part in one of the two MI projects, and you will get coaching and use an app for that project to improve your health. One project is on teen pregnancy prevention and the other is on healthy eating, physical activity, and avoiding cigarettes. Participants will use an app via phone to do the project, answer survey questions, keep track of health, and learn more about healthy behaviors.

Three hundred young men, ages 15 to 24 years, will be randomized to one of two intervention arms, a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP) or a CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness). The two interventions are identical in length and timing but vary in the target behavior focus (pregnancy prevention versus fitness).

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
15 Years 至 24 Years(Child, Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Young men aged 15-24
  • •Sexually active with female partners
  • •Enrolled patients at New York Presbyterian Hospital's Young Men's Clinic (YMC) in Washington Heights or the school-based health centers (SBHCs) at George Washington Educational Campus in Washington Heights or John F. Kennedy campus in the Bronx

排除标准

  • •Do not have iPhone or Android Smartphone
  • •Participated in any of the following programs within the last year, or have a brother who has participated in these programs:
  • •Fathers Raising Responsible Men (FRRM)
  • •Peer Group Connection (PGC)
  • •NYC Teens Connection
  • •Children's AID Society (CAS)-TPP Initiative
  • •Achieving Condom Empowerment-Plus (ACE+) Study
  • •Have had a medical treatment or surgical procedure that makes it impossible to father a child, such as a vasectomy
  • •Cannot commit to participating in a smartphone-based study for the next 15 months

研究组 & 干预措施

CAMI-TPP

Experimental

Young men, ages 15 to 24 years, will be receiving a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP).

干预措施: CAMI-TPP (Behavioral)

CAMI-Fitness

Active Comparator

Young men, ages 15 to 24 years, will be receiving CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness).

干预措施: CAMI-Fitness (Behavioral)

结局指标

主要结局

Change in number of participants that had sexual intercourse without using a condom since the last assessment Condom use at last sex

时间窗: Baseline and 12 weeks

In the past 3 months, how many times have you had sexual intercourse without using a condom?

次要结局

  • Change in number of participants that had sexual intercourse in the past without the partner using any contraception since the last assessment(Baseline and 12 weeks)
  • Number of participants completing a reproductive health service visit with STI testing(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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