IncarcerationNCT03025191
Prison Connect-STI/HIV Prevention Intervention for Couples Affected by Incarceration
A study testing Speaker/Listener technique, Social Support and Problem-Solving in people with Incarceration, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to adapt an existing couples-level HIV prevention intervention for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and acceptability among men incarcerated in the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incarceration
- What is being tested?
- Speaker/Listener technique, Social Support and Problem-Solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- eight HIV-positive and HIV-negative/unknown status male inmates and their partners (N=16 couples, 32 participants).
- Male Participants
- at least 18 years of age
- able to communicate in English, currently
- incarcerated in the Connecticut Department of Correction (CTDOC), due to be released within three months.
- have a committed female partner who is not currently incarcerated and willing to participate in the study, and is
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- not concerned participation will cause violence in the relationship.
- Female partners
- be able to communicate in English
- not currently incarcerated
- confirm the committed partnership with the male inmate and willingness to participate in the study
- not concerned participation in the study would cause violence in the relationship.
Who cannot join
- restricted to English-speaking participants due to language availability of staff and intervention materials.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Development and Acceptability Evaluation of a Novel STI/HIV Prevention Intervention for Couples Affected by Incarceration
The purpose of this study is to adapt an existing couples-level HIV prevention intervention for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and acceptability among men incarcerated in the Connecticut Department of Correction (CTDOC) and their community-dwelling committed female partners.
Read the detailed description
This pilot study will recruit male inmates in the Connecticut Department of Correction and their community-dwelling female partner. Using an adapted version of an efficacious couples-level HIV prevention intervention for community populations (CONNECT; PI: El-Bassel), this study will pilot test a single in-prison intervention session using face-to-face or teleconferencing modalities and a brief community follow-up session. Feasibility and acceptability among the inmates and their partners will be assessed.
- Conditions
- Incarceration
- Being tested
- Speaker/Listener technique, Social Support, Problem-Solving, Goal Setting
- Keywords
- incarceration, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speaker/Listener techniqueBehavioural
Couple will learn taking turns as the speaker and as the listener who paraphrases the speaker's point.The couple will then identify an issue they have faced in their relationship and will role-play using the technique to discuss it.
Social SupportBehavioural
Identification of and mapping sources of social support and the types of support provided by members of the network. Participants will also identify the strengths and weaknesses of their support network and think through ways to strengthen those networks.
Problem-SolvingBehavioural
Couple will be taught steps to systematically analyze a problem and brainstorm solutions through a short video. Steps include identify the trigger/problem; identify the goal for addressing the problem; brainstorm possible solutions for each partner; evaluate the solutions and pick the best; and act on the best solution.
Goal SettingBehavioural
Couple will be introduced to the concept of short- and long-term goal setting, including components of goal and planning for potential barriers. The couple will then set a goal for themselves that incorporates the skills obtained during the intervention, such as strengthening ties in their social support network. Participants will fill in a worksheet outlining their goal, potential barriers, and solutions to those barriers.
| Study group | Role | What they receive |
|---|---|---|
| Prison Connect | Experimental | Not described Receives: Behavioral: Speaker/Listener technique; Behavioral: Social Support; Behavioral: Problem-Solving; Behavioral: Goal Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of intervention procedures and content by administration of a brief acceptability questionnaire among incarcerated men and their partners
Questions about how participant feels about the program activities.
Measured: 15 Minutes
Secondary outcomes (1)
Acceptability of follow-up procedures and follow-up intervention content by administration of a brief acceptability questionnaire among male releasees and their partners.
Using tracking information provided at the time of in-prison session of PRISON CONNECT investigators will initiate contact with couples within the first month of release and conduct the follow-up visit at a location/time convenient for couples (e.g., team's research facility in New Haven, CT). The session will include a review of PRISON CONNECT intervention content.
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IncarcerationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Columbia University
- Responsible party
- Sponsor
- Investigators
- Maria Khan, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025191
- Sponsor's protocol ID
- 15-00604
- Status last verified
- Dec 2017
- First submitted
- 17 Jan 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Acceptability Evaluation of a Novel STI/HIV Prevention Intervention for Couples Affected by Incarceration
- ClinicalTrials.gov ID
- NCT03025191
- Acronym / sponsor ID
- 15-00604
- Conditions
- Incarceration
- Keywords
- incarceration, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Yale University, Columbia University
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Jan 2017 (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.
The purpose of this study is to adapt an existing couples-level HIV prevention intervention for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and acceptability among men incarcerated in the Connecticut Department of Correction (CTDOC) and their community-dwelling committed female partners.
Detailed description
This pilot study will recruit male inmates in the Connecticut Department of Correction and their community-dwelling female partner. Using an adapted version of an efficacious couples-level HIV prevention intervention for community populations (CONNECT; PI: El-Bassel), this study will pilot test a single in-prison intervention session using face-to-face or teleconferencing modalities and a brief community follow-up session. Feasibility and acceptability among the inmates and their partners will be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prison Connect | Experimental | Behavioral: Speaker/Listener technique, Behavioral: Social Support, Behavioral: Problem-Solving, Behavioral: Goal Setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- eight HIV-positive and HIV-negative/unknown status male inmates and their partners (N=16 couples, 32 participants).
- Male Participants
- at least 18 years of age
- able to communicate in English, currently
- incarcerated in the Connecticut Department of Correction (CTDOC), due to be released within three months.
Key exclusion criteria (1 listed)
- restricted to English-speaking participants due to language availability of staff and intervention materials.
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 |
|---|---|---|
| Speaker/Listener techniqueCouple will learn taking turns as the speaker and as the listener who paraphrases the speaker's point.The couple will then identify an issue they have faced in their relationship and will role-play using the technique to discuss it. | Behavioural | Prison Connect |
| Social SupportIdentification of and mapping sources of social support and the types of support provided by members of the network. Participants will also identify the strengths and weaknesses of their support network and think through ways to strengthen those networks. | Behavioural | Prison Connect |
| Problem-SolvingCouple will be taught steps to systematically analyze a problem and brainstorm solutions through a short video. Steps include identify the trigger/problem; identify the goal for addressing the problem; brainstorm possible solutions for each partner; evaluate the solutions and pick the best; and act on the best solution. | Behavioural | Prison Connect |
| Goal SettingCouple will be introduced to the concept of short- and long-term goal setting, including components of goal and planning for potential barriers. The couple will then set a goal for themselves that incorporates the skills obtained during the intervention, such as strengthening ties in their social support network. Participants will fill in a worksheet outlining their goal, potential barriers, and solutions to those barriers. | Behavioural | Prison Connect |
Primary outcome
Acceptability of intervention procedures and content by administration of a brief acceptability questionnaire among incarcerated men and their partners
Time frame: 15 Minutes
Questions about how participant feels about the program activities.
1 secondary outcome
Acceptability of follow-up procedures and follow-up intervention content by administration of a brief acceptability questionnaire among male releasees and their partners.
Time frame: 15 Minutes
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 14 Dec 2017.
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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.
Maria Khan, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speaker/Listener technique, Social Support and Problem-Solving in people with Incarceration, run by NYU Langone Health 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 12 inclusion and 1 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 14 Dec 2017. 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?
Acceptability of intervention procedures and content by administration of a brief acceptability questionnaire among incarcerated men and their partners (time frame: 15 Minutes). 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 14 Dec 2017.