Clinical trial NCT01643005: A Couple-Based Relationship Strengthening HIV Intervention for Young Parents
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: High risk sexual behavior
timeFrame: Baseline
measure: High risk sexual behavior
timeFrame: 4 months
measure: High risk sexual behavior
timeFrame: 8 months
Secondary outcomes:
measure: Relationship Functioning at 4 months
timeFrame: 4 months
measure: Relationship Dissolution at 4 months
timeFrame: 4 months
measure: Change from Baseline in relationship based determinants at 4 months
timeFrame: 4 months
measure: Relationship Functioning at 8 months
timeFrame: 8 months
measure: Relationship Dissolution at 8 months
timeFrame: 8 months
measure: Change from Baseline in relationship based determinants at 8 months
timeFrame: 8 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Children's Community Programs of Connecticut
state: Connecticut
Study officials:
affiliation: Yale School of Public Health
name: Trace S Kershaw, PhD
role: PRINCIPAL_INVESTIGATOR
References: