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Clinical Trials/NCT01643005
NCT01643005CompletedNot Applicable

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

Yale University1 site in 1 country100 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
High risk sexual behavior

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
14 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Active Control Group

Active Comparator

For the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator.

Intervention: Parenting Program Intervention (Behavioral)

Relationship Strengthening HIV Prevent.

Experimental

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: Relationship Strengthening HIV Prevention Intervention (Behavioral)

Outcomes

Primary Outcomes

High risk sexual behavior

Time Frame: 8 months

Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy

High risk sexual behavior

Time Frame: Baseline

Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy

High risk sexual behavior

Time Frame: 4 months

Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy

Secondary Outcomes

  • Relationship Functioning at 4 months(4 months)
  • Relationship Dissolution at 4 months(4 months)
  • Change from Baseline in relationship based determinants at 4 months(4 months)
  • Relationship Functioning at 8 months(8 months)
  • Relationship Dissolution at 8 months(8 months)
  • Change from Baseline in relationship based determinants at 8 months(8 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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