Clinical trial NCT03025191: Prison Connect-STI/HIV Prevention Intervention for Couples Affected by Incarceration
Official title: Development and Acceptability Evaluation of a Novel STI/HIV Prevention Intervention for Couples Affected by Incarceration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incarceration
Keywords: incarceration
HIV
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Yale University
name: Columbia University
First posted: 2017-01-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of intervention procedures and content by administration of a brief acceptability questionnaire among incarcerated men and their partners
timeFrame: 15 Minutes
Secondary outcomes:
measure: Acceptability of follow-up procedures and follow-up intervention content by administration of a brief acceptability questionnaire among male releasees and their partners.
timeFrame: 15 Minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Maria Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: