A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643005
• Other study ID #: 1105008508
• Secondary ID: R34MH094354
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: May 13, 2020

Study information

• Verified date: June 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 13, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.
• Parenting Program Intervention
Nurturing Parenting curriculum delivered in a group format.

Locations

Country	Name	City	State
United States	Children's Community Programs of Connecticut	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High risk sexual behavior	Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy	Baseline
Primary	High risk sexual behavior	Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy	4 months
Primary	High risk sexual behavior	Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy	8 months
Secondary	Relationship Functioning at 4 months		4 months
Secondary	Relationship Dissolution at 4 months		4 months
Secondary	Change from Baseline in relationship based determinants at 4 months	Attachment, Intimacy, Communication, Equity, Relationship Conflict	4 months
Secondary	Relationship Functioning at 8 months		8 months
Secondary	Relationship Dissolution at 8 months		8 months
Secondary	Change from Baseline in relationship based determinants at 8 months	Attachment, Intimacy, Communication, Equity, Relationship Conflict	8 months