Motivational Interviewing for Getting Healthy TodaY Study

NCT03410225 | Completed

• 1 other identifier: AAAR5303
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Pregnancy Related; Diet Modification

Keywords

Pregnancy Prevention; Male Involvement

Outcome Measures

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

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

  Baseline and 12 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

CAMI-TPP

EXPERIMENTAL

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

Behavioral: CAMI-TPP

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).

Behavioral: CAMI-Fitness

Interventions

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.

Also known as: CAMI - Teen Pregnancy Prevention

CAMI-TPP

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.

Also known as: CAMI - healthy diet, physical activity and tobacco avoidance

CAMI-Fitness

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• The Office of Adolescent Health, HHS: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (3)

George Washington Educational Campus School-Based Health Center

New York, New York, 10032, United States

Location

The Young Men's Clinic

New York, New York, 10032, United States

Location

John F. Kennedy Educational Campus School-Based Health Center

New York, New York, 10463, United States

Location

Related Publications (8)

• Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001-2008. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S43-8. doi: 10.2105/AJPH.2013.301416. Epub 2013 Dec 19.

  PMID: 24354819 BACKGROUND

• Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep. 2012 Aug 28;61(1):1-72.

  PMID: 24974589 BACKGROUND

• Males MA. Adult involvement in teenage childbearing and STD. Lancet. 1995 Jul 8;346(8967):64-5. doi: 10.1016/s0140-6736(95)92105-2.

  PMID: 7603210 BACKGROUND

• Hollis JF, Polen MR, Whitlock EP, Lichtenstein E, Mullooly JP, Velicer WF, Redding CA. Teen reach: outcomes from a randomized, controlled trial of a tobacco reduction program for teens seen in primary medical care. Pediatrics. 2005 Apr;115(4):981-9. doi: 10.1542/peds.2004-0981.

  PMID: 15805374 BACKGROUND

• McCambridge J, Strang J. The efficacy of single-session motivational interviewing in reducing drug consumption and perceptions of drug-related risk and harm among young people: results from a multi-site cluster randomized trial. Addiction. 2004 Jan;99(1):39-52. doi: 10.1111/j.1360-0443.2004.00564.x.

  PMID: 14678061 BACKGROUND

• Weinstein P, Harrison R, Benton T. Motivating mothers to prevent caries: confirming the beneficial effect of counseling. J Am Dent Assoc. 2006 Jun;137(6):789-93. doi: 10.14219/jada.archive.2006.0291.

  PMID: 16803808 BACKGROUND

• Jensen CD, Cushing CC, Aylward BS, Craig JT, Sorell DM, Steele RG. Effectiveness of motivational interviewing interventions for adolescent substance use behavior change: a meta-analytic review. J Consult Clin Psychol. 2011 Aug;79(4):433-40. doi: 10.1037/a0023992.

  PMID: 21728400 BACKGROUND

• 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.

  PMID: 17351283 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David L. Bell, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 25, 2018
• Study Start: June 1, 2019
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)