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Motivational Interviewing for Getting Healthy TodaY Study (MIGHTY)

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ClinicalTrials.gov Identifier: NCT03410225
Recruitment Status : Not yet recruiting
First Posted : January 25, 2018
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
The Office of Adolescent Health, HHS
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pregnancy Related Diet Modification Behavioral: CAMI-TPP Behavioral: CAMI-Fitness Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized through a permuted random blocks assignment procedure with block stratification (by age group). Strings of varying length (2, 4, 6, 8, for example), with equal allocations T and C (randomly ordered) within a string, are combined to produce a single, long string of T and C combinations (e.g. TTCCTCTTCCC, etc.). Because the long string is made up of blocks of T and C strings with equal allocations of Ts and Cs, the observed percentage of the sample in the treatment condition will always be very close to 0.5, and the true P(T) for all observations will be 0.5. Randomization will be conducted via an algorithm on the online portal at the time of enrollment in order for the project coordinator to assign the participant to an intervention arm.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Computer-Assisted Motivational Interviewing Intervention to Facilitate Teen Pregnancy Prevention and Fitness Behavior Changes: A Randomized Trial for Young Men
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: CAMI-TPP
Young men, ages 15 to 24 years, will be receiving a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP).
Behavioral: CAMI-TPP
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 Name: CAMI - Teen Pregnancy Prevention

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)?



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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410225


Contacts
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Contact: David L Bell, MD MPH 212-305-7677 dlb54@columbia.edu

Locations
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United States, New York
George Washington Educational Campus School-Based Health Center Not yet recruiting
New York, New York, United States, 10032
Contact: Melanie A Gold, DO         
The Young Men's Clinic Not yet recruiting
New York, New York, United States, 10032
Contact: David L Bell, MD MPH         
John F. Kennedy Educational Campus School-Based Health Center Not yet recruiting
New York, New York, United States, 10463
Contact: Melanie A Gold, DO         
Sponsors and Collaborators
Columbia University
The Office of Adolescent Health, HHS
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: David Bell, MD MPH Associate Professor of Pediatrics and Population and Family Health at the Columbia University Medical Center, Department of Pediatrics

Publications:

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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT03410225     History of Changes
Other Study ID Numbers: AAAR5303
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Columbia University:
Pregnancy Prevention
Male Involvement