NCT03025191

Brief 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 Connecticut Department of Correction (CTDOC) and their community-dwelling committed female partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

January 17, 2017

Last Update Submit

December 12, 2017

Conditions

Incarceration

Keywords

incarcerationHIV

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    15 Minutes

Study Arms (1)

Prison Connect

EXPERIMENTAL
Behavioral: Speaker/Listener techniqueBehavioral: Social SupportBehavioral: Problem-SolvingBehavioral: Goal Setting

Interventions

Speaker/Listener techniqueBEHAVIORAL

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.

Prison Connect
Social SupportBEHAVIORAL

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.

Prison Connect
Problem-SolvingBEHAVIORAL

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.

Prison Connect
Goal SettingBEHAVIORAL

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.

Prison Connect

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • restricted to English-speaking participants due to language availability of staff and intervention materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Organizational Objectives

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services Administration

Study Officials

  • Maria Khan, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 19, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 14, 2017

Record last verified: 2017-12

Locations

US(1)