Motivational Interviewing for Getting Healthy TodaY Study

Not Applicable

Completed

• Conditions: Diet Modification; Pregnancy Related
• Interventions: Behavioral: CAMI-TPP; Behavioral: CAMI-Fitness

• Registration Number: NCT03410225
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-25
• Study Start: 2019-06-01
• Primary Completion: 2019-08-28
• Study Completion: 2019-08-28
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAMI-TPP	CAMI-TPP	Young men, ages 15 to 24 years, will be receiving a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP).
CAMI-Fitness	CAMI-Fitness	Young men, ages 15 to 24 years, will be receiving CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness).

Primary Outcome Measures

Name	Time	Method
Change in number of participants that had sexual intercourse without using a condom since the last assessment Condom use at last sex	Baseline and 12 weeks	In the past 3 months, how many times have you had sexual intercourse without using a condom?

Secondary Outcome Measures

Name	Time	Method
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	In the past 3 months, how many times have you had sexual intercourse without using any of these methods of birth control?
Number of participants completing a reproductive health service visit with STI testing	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)?

Trial Locations

Locations (3)

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

The Young Men's Clinic; 🇺🇸 New York, New York, United States

John F. Kennedy Educational Campus School-Based Health Center; 🇺🇸 New York, New York, United States