Clinical trial NCT03410225: Motivational Interviewing for Getting Healthy TodaY Study
Official title: Computer-Assisted Motivational Interviewing Intervention to Facilitate Teen Pregnancy Prevention and Fitness Behavior Changes: A Randomized Trial for Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Diet Modification
Keywords: Pregnancy Prevention
Male Involvement
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: The Office of Adolescent Health, HHS
name: Centers for Disease Control and Prevention
First posted: 2018-01-25
Enrollment: 26
Sex: MALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Change in number of participants that had sexual intercourse without using a condom since the last assessment Condom use at last sex
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in number of participants that had sexual intercourse in the past without the partner using any contraception since the last assessment
timeFrame: Baseline and 12 weeks
measure: Number of participants completing a reproductive health service visit with STI testing
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: George Washington Educational Campus School-Based Health Center
state: New York
city: New York
country: United States
facility: The Young Men's Clinic
state: New York
city: New York
country: United States
facility: John F. Kennedy Educational Campus School-Based Health Center
state: New York
Study officials:
affiliation: Columbia University
name: David L. Bell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.