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A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Yale University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01643005
First received: July 12, 2012
Last updated: July 16, 2012
Last verified: July 2012

July 12, 2012
July 16, 2012
August 2012
January 2014   (final data collection date for primary outcome measure)
  • High risk sexual behavior [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
  • High risk sexual behavior [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
  • High risk sexual behavior [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
Same as current
Complete list of historical versions of study NCT01643005 on ClinicalTrials.gov Archive Site
  • Relationship Functioning at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Relationship Dissolution at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change from Baseline in relationship based determinants at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Attachment, Intimacy, Communication, Equity, Relationship Conflict
  • Relationship Functioning at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Relationship Dissolution at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Change from Baseline in relationship based determinants at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Attachment, Intimacy, Communication, Equity, Relationship Conflict
Same as current
Not Provided
Not Provided
 
A Couple-Based Relationship Strengthening HIV Intervention for Young Parents
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
  • 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
  • Behavioral: Parenting Program Intervention
    Nurturing Parenting curriculum delivered in a group format.
    Other Name: Nurturing Parenting
  • Active Comparator: Active Control Group
    For the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator.
    Intervention: Behavioral: Parenting Program Intervention
  • 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.
    Intervention: Behavioral: Relationship Strengthening HIV Prevention Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
July 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
14 Years and older
Yes
Contact: Valen Diaz, B.A. 203-785-5293
United States
 
NCT01643005
1105008508, R34MH094354
Yes
Yale University
Yale University
National Institute of Mental Health (NIMH)
Principal Investigator: Trace S Kershaw, PhD Yale School of Public Health
Yale University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP