Skip to main content
OpenTrials
Completed

NCT Number: NCT03410225

Motivational Interviewing for Getting Healthy TodaY Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–24 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

George Washington Educational Campus School-Based Health Center, New York, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CAMI-TPP

Behavioral

The TPP group will receive four 30-minute sessions of one-on-one coaching over 12 weeks with a MI coach; the sessions will be guided by personalized feedback aimed at increasing condom use, supporting female partners in contraceptive use, and obtaining reproductive health services and STI testing. MI counseling sessions will be conducted by phone or video call.

Other names: CAMI - Teen Pregnancy Prevention

CAMI-Fitness

Behavioral

The Fitness group will also receive four 30-minute sessions of one-on-one coaching over 12 weeks with a MI coach; these sessions will be guided by personalized feedback aimed at healthy diet, physical activity and tobacco avoidance. MI counseling sessions will be conducted by phone or video call.

Other names: CAMI - healthy diet, physical activity and tobacco avoidance

Primary outcomes

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

    Time frame: Baseline and 12 weeks

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

Secondary outcomes

  1. Change in number of participants that had sexual intercourse in the past without the partner using any contraception since the last assessment

    Time frame: Baseline and 12 weeks

    In the past 3 months, how many times have you had sexual intercourse without using any of these methods of birth control?

  2. Number of participants completing a reproductive health service visit with STI testing

    Time frame: Baseline and 12 weeks

    In the last 3 months, that is, since {current date minus 3 months} , have you been tested by a doctor, nurse, or health provider for a sexually transmitted disease like gonorrhea, chlamydia, herpes, or syphilis (not including HIV)?

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Centers for Disease Control and Prevention
  • The Office of Adolescent Health, HHS

Registry information

Official study title

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

Acronym: MIGHTY

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2018
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.