A Couple-Based Relationship Strengthening HIV Intervention for Young Parents
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ClinicalTrials.gov Identifier: NCT01643005 |
Recruitment Status
: Unknown
Verified July 2012 by Yale University.
Recruitment status was: Not yet recruiting
First Posted
: July 17, 2012
Last Update Posted
: July 17, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Behavioral: Relationship Strengthening HIV Prevention Intervention Behavioral: Parenting Program Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 Start Date : | August 2012 |
Estimated Primary Completion Date : | January 2014 |
Estimated Study Completion Date : | July 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Active Control Group
For the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator.
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Behavioral: Parenting Program Intervention
Nurturing Parenting curriculum delivered in a group format.
Other Name: Nurturing Parenting
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Experimental: Relationship Strengthening HIV Prevent.
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.
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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.
Other Name: Partners in Life
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- High risk sexual behavior [ Time Frame: Baseline ]Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
- High risk sexual behavior [ Time Frame: 4 months ]Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
- High risk sexual behavior [ Time Frame: 8 months ]Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
- Relationship Functioning at 4 months [ Time Frame: 4 months ]
- Relationship Dissolution at 4 months [ Time Frame: 4 months ]
- Change from Baseline in relationship based determinants at 4 months [ Time Frame: 4 months ]Attachment, Intimacy, Communication, Equity, Relationship Conflict
- Relationship Functioning at 8 months [ Time Frame: 8 months ]
- Relationship Dissolution at 8 months [ Time Frame: 8 months ]
- Change from Baseline in relationship based determinants at 8 months [ Time Frame: 8 months ]Attachment, Intimacy, Communication, Equity, Relationship Conflict

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Ages Eligible for Study: | 14 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643005
Contact: Valen Diaz, B.A. | 203-785-5293 |
United States, Connecticut | |
Children's Community Programs of Connecticut | Not yet recruiting |
New Haven, Connecticut, United States, 06515 | |
Contact: Victoria Dancy vdancy@childrenscommunityprograms.org | |
Principal Investigator: Hans Sherrod |
Principal Investigator: | Trace S Kershaw, PhD | Yale School of Public Health |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01643005 History of Changes |
Other Study ID Numbers: |
1105008508 R34MH094354 ( U.S. NIH Grant/Contract ) |
First Posted: | July 17, 2012 Key Record Dates |
Last Update Posted: | July 17, 2012 |
Last Verified: | July 2012 |
Keywords provided by Yale University:
HIV |