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A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

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ClinicalTrials.gov Identifier: NCT01643005
Recruitment Status : Unknown
Verified July 2012 by Yale University.
Recruitment status was:  Not yet recruiting
First Posted : July 17, 2012
Last Update Posted : July 17, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study seeks to develop, implement, and assess an innovative 15-session couple-based intervention to be delivered in a group format to young parents that aims to strengthen relationships and reduce HIV risk. The ultimate goal of our intervention is to reduce HIV/STD risk (concurrency, number of partners, unprotected sex), strengthen relationships, and improve parenting among young parenting heterosexual couples.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Relationship Strengthening HIV Prevention Intervention Behavioral: Parenting Program Intervention Not Applicable

Detailed Description:
This study develops a couple-based HIV prevention intervention that is innovative and important because it integrates an intervention that improves sexual health, relationship functioning, and parenting skills. Our intervention will be integrated with an existing community based parenting program. By targeting high risk heterosexual couples experiencing an important life transition that increases their stress, conflict, and sexual risk, the investigators can provide maximum benefit to the men, women, and children in our communities. Using the guiding framework of Attachment Theory and the principles of Emotion Focused Therapy, the investigators will directly address issues of emotion, intimacy,and relationship functioning to create an intervention that strengthens romantic relationships and reduces HIV risk behavior. The investigators will conduct a small pilot randomized controlled trial of 50 parenting couples randomized to either the relationship strengthening HIV prevention intervention or an active control. The intervention will last 15 weeks and each session will be approximately 1.5 hours long. The investigators will assess couples at baseline, 4-months, and 8-months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Phase of Couples-Based Intervention to Reduce HIV/STD Risk (Concurrency, Number of Partners, Unprotected Sex), Strengthen Relationships, and Improve Parenting Among Young Parenting Heterosexual Couples
Study Start Date : August 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Parenting
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active Control Group
For the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator.
 Behavioral: Parenting Program Intervention
Nurturing Parenting curriculum delivered in a group format.
Other Name: Nurturing Parenting
Experimental: Relationship Strengthening HIV Prevent.
The relationship strengthening HIV intervention will build on the structure of the Nurturing Parenting Groups and will be integrated so that participants will receive the Nurturing Parenting Groups plus the relationship strengthening HIV intervention.
 Behavioral: Relationship Strengthening HIV Prevention Intervention
The relationship strengthening HIV intervention will build on the structure of the Nurturing Parenting Groups and will be integrated so that participants will receive the Nurturing Parenting Groups plus the relationship strengthening HIV intervention.
Other Name: Partners in Life


Outcome Measures
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Primary Outcome Measures :
  1. High risk sexual behavior [ Time Frame: Baseline ]
    Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy

  2. High risk sexual behavior [ Time Frame: 4 months ]
    Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy

  3. High risk sexual behavior [ Time Frame: 8 months ]
    Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy


Secondary Outcome Measures :
  1. Relationship Functioning at 4 months [ Time Frame: 4 months ]
  2. Relationship Dissolution at 4 months [ Time Frame: 4 months ]
  3. Change from Baseline in relationship based determinants at 4 months [ Time Frame: 4 months ]
    Attachment, Intimacy, Communication, Equity, Relationship Conflict

  4. Relationship Functioning at 8 months [ Time Frame: 8 months ]
  5. Relationship Dissolution at 8 months [ Time Frame: 8 months ]
  6. Change from Baseline in relationship based determinants at 8 months [ Time Frame: 8 months ]
    Attachment, Intimacy, Communication, Equity, Relationship Conflict


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women's age between 14 and 25
  • Men's age 14 or older
  • Have a child that is 0-1 year old
  • In a romantic relationship with the mother/father of the baby
  • Not known to be HIV positive
  • English speaking

Exclusion Criteria:

  • Child older than 1 year
  • HIV positive
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01643005


Contacts
Contact: Valen Diaz, B.A. 203-785-5293

Locations
United States, Connecticut
Children's Community Programs of Connecticut Not yet recruiting
New Haven, Connecticut, United States, 06515
Contact: Victoria Dancy       vdancy@childrenscommunityprograms.org   
Principal Investigator: Hans Sherrod         
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Trace S Kershaw, PhD Yale School of Public Health
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01643005     History of Changes
Other Study ID Numbers: 1105008508
R34MH094354 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by Yale University:
HIV