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Completed

NCT Number: NCT01643005

A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

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.

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Key information

Conditions

HIV

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Community Programs of Connecticut

New Haven, Connecticut, 06515, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relationship Strengthening HIV Prevention Intervention

Behavioral

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 names: Partners in Life

Parenting Program Intervention

Behavioral

Nurturing Parenting curriculum delivered in a group format.

Other names: Nurturing Parenting

Primary outcomes

  1. High risk sexual behavior

    Time frame: Baseline

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

  2. High risk sexual behavior

    Time frame: 4 months

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

  3. High risk sexual behavior

    Time frame: 8 months

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

Secondary outcomes

  1. Relationship Functioning at 4 months

    Time frame: 4 months

  2. Relationship Dissolution at 4 months

    Time frame: 4 months

  3. Change from Baseline in relationship based determinants at 4 months

    Time frame: 4 months

    Attachment, Intimacy, Communication, Equity, Relationship Conflict

  4. Relationship Functioning at 8 months

    Time frame: 8 months

  5. Relationship Dissolution at 8 months

    Time frame: 8 months

  6. Change from Baseline in relationship based determinants at 8 months

    Time frame: 8 months

    Attachment, Intimacy, Communication, Equity, Relationship Conflict

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2012
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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