Prison Connect-STI/HIV Prevention Intervention for Couples Affected by Incarceration

Incarceration Clinical Trial

Official title:

Development and Acceptability Evaluation of a Novel STI/HIV Prevention Intervention for Couples Affected by Incarceration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025191
• Other study ID #: 15-00604
• Status: Completed
• Phase: N/A
• First received: January 17, 2017
• Last updated: December 12, 2017
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Incarceration

Intervention

Behavioral:
• Speaker/Listener technique
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 Support
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-Solving
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 Setting
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	Columbia University, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	15 Minutes