A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Parenting Program Intervention; Behavioral: Relationship Strengthening HIV Prevention Intervention

• Registration Number: NCT01643005
• Lead Sponsor: Yale University

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 Timeline

• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Study Start: 2012-08
• Primary Completion: 2020-05-13
• Study Completion: 2020-05-13
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Child older than 1 year
• HIV positive

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Control Group	Parenting Program Intervention	For the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator.
Relationship Strengthening HIV Prevent.	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.

Primary Outcome Measures

Name	Time	Method
High risk sexual behavior	8 months	Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy

Secondary Outcome Measures

Name	Time	Method
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	Attachment, Intimacy, Communication, Equity, Relationship Conflict
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	Attachment, Intimacy, Communication, Equity, Relationship Conflict

Trial Locations

Locations (1)

Children's Community Programs of Connecticut; 🇺🇸 New Haven, Connecticut, United States