HIVNCT01643005
A Couple-Based Relationship Strengthening HIV Intervention for Young Parents
A study testing Relationship Strengthening HIV Prevention Intervention and Parenting Program Intervention in people with HIV, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Relationship Strengthening HIV Prevention Intervention and Parenting Program Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 13 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Child older than 1 year
- HIV positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Community Programs of Connecticut
New Haven, Connecticut, 06515
About this study
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
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Relationship Strengthening HIV Prevention Intervention, Parenting Program Intervention
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship Strengthening HIV Prevention InterventionBehavioural
Also called Partners in Life
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 InterventionBehavioural
Also called Nurturing Parenting
Nurturing Parenting curriculum delivered in a group format.
| Study group | Role | What they receive |
|---|---|---|
| Active Control Group | Active comparator | For the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator. Receives: 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. Receives: Behavioral: Relationship Strengthening HIV Prevention Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
High risk sexual behavior
Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
Measured: Baseline
High risk sexual behavior
Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
Measured: 4 months
High risk sexual behavior
Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
Measured: 8 months
Secondary outcomes (6)
Relationship Functioning at 4 months
Measured: 4 months
Relationship Dissolution at 4 months
Measured: 4 months
Change from Baseline in relationship based determinants at 4 months
Attachment, Intimacy, Communication, Equity, Relationship Conflict
Measured: 4 months
Relationship Functioning at 8 months
Measured: 8 months
Relationship Dissolution at 8 months
Measured: 8 months
Change from Baseline in relationship based determinants at 8 months
Attachment, Intimacy, Communication, Equity, Relationship Conflict
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startAug 2012
- Primary completion13 May 2020
- Study completion13 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Trace S Kershaw, PhD, Principal investigator, Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643005
- Sponsor's protocol ID
- 1105008508
- Other IDs
- R34MH094354
- Status last verified
- Jun 2020
- First submitted
- 12 Jul 2012
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01643005
- Acronym / sponsor ID
- 1105008508
- Conditions
- HIV
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2012
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Control Group | Active comparator | Behavioral: Parenting Program InterventionFor the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator. |
| Relationship Strengthening HIV Prevent. | Experimental | Behavioral: Relationship Strengthening HIV Prevention InterventionThe 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Child older than 1 year
- HIV positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relationship Strengthening HIV Prevention InterventionAlso: Partners in LifeThe 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. | Behavioural | Relationship Strengthening HIV Prevent. |
| Parenting Program InterventionAlso: Nurturing ParentingNurturing Parenting curriculum delivered in a group format. | Behavioural | Active Control Group |
Primary outcome
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
6 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trace S Kershaw, PhD principal investigator
Yale School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relationship Strengthening HIV Prevention Intervention and Parenting Program Intervention in people with HIV, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High risk sexual behavior (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.