A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

NCT01643005 | Completed DMC

• 2 other identifiers: 1105008508R34MH094354
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV

Outcome Measures

Primary Outcomes (3)

• High risk sexual behavior

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

  Baseline

• High risk sexual behavior

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

  4 months

• High risk sexual behavior

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

  8 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Active Control Group

ACTIVE COMPARATOR

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

Behavioral: Parenting Program Intervention

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.

Behavioral: Relationship Strengthening HIV Prevention Intervention

Interventions

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.

Also known as: Partners in Life

Relationship Strengthening HIV Prevent.

Parenting Program Intervention BEHAVIORAL

Nurturing Parenting curriculum delivered in a group format.

Also known as: Nurturing Parenting

Active Control Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Child older than 1 year
• HIV positive

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Community Programs of Connecticut

New Haven, Connecticut, 06515, United States

Location

Study Officials

• Trace S Kershaw, PhD

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 17, 2012
• Study Start: August 1, 2012
• Primary Completion: May 13, 2020
• Study Completion: May 13, 2020
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

US (1)