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Using Multimedia Technologies to Disseminate an HIV Prevention

Primary Purpose

HIV Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multimedia Connect
Traditional Connect
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

To be eligible for the study, CBOs must have reported that they

  • had 501c3 status;
  • provided at least a minimum level of direct contact HIV prevention services to clientele; and
  • that their target population for services included heterosexual men and women.

Exclusion Criteria:

-

Sites / Locations

  • Columbia University Social Intervention Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Traditional Connect

Arm Description

Multimedia Connect and the Multimedia facilitator training curriculum with a 4-day, face-to-face structured orientation and training for implementation, and planned, investigative team initiated telephone consultations with CBO staff to provide technical assistance at 2 and 4 months following the training workshop;

The original, manualized version of Connect (CDC DEBI)and manualized facilitator training curriculum with a 4-day, face-to-face structured orientation and training for implementation, and planned, investigative team initiated telephone consultation with CBO staff to provide technical assistance at 2 and 4 months following the training workshop.

Outcomes

Primary Outcome Measures

The mean number of Connect sessions per client/couple implemented by participating staff (at each agency) in the prior 6 months

Secondary Outcome Measures

To test whether key variables mediate adoption outcomes (e.g. staff attitudes and opinions towards programming and technology).

Full Information

First Posted
May 20, 2013
Last Updated
July 29, 2013
Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01863537
Brief Title
Using Multimedia Technologies to Disseminate an HIV Prevention
Official Title
Using Multimedia Technologies to Disseminate an HIV Prevention Program for Couples
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This RCT will randomly assign 40 of the CBOs to receive the Multimedia intervention and training package (Multimedia)and the other 40 to receive the original, manualized Connect intervention and training package (Traditional). The technology transfer process involves all agencies receiving four days of training and two planned technical assistance conference calls, by study investigative staff, in the first four months following training. Telephone assessments completed by up to 6 staff at each agency will measure primary outcomes, mediating, moderating and process measure variables at baseline, 6, 12 and 18 months post-technology transfer. The primary outcome of the study is adoptions of the Connect intervention. The unit of analysis is the CBO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Multimedia Connect and the Multimedia facilitator training curriculum with a 4-day, face-to-face structured orientation and training for implementation, and planned, investigative team initiated telephone consultations with CBO staff to provide technical assistance at 2 and 4 months following the training workshop;
Arm Title
Traditional Connect
Arm Type
Active Comparator
Arm Description
The original, manualized version of Connect (CDC DEBI)and manualized facilitator training curriculum with a 4-day, face-to-face structured orientation and training for implementation, and planned, investigative team initiated telephone consultation with CBO staff to provide technical assistance at 2 and 4 months following the training workshop.
Intervention Type
Behavioral
Intervention Name(s)
Multimedia Connect
Intervention Type
Behavioral
Intervention Name(s)
Traditional Connect
Primary Outcome Measure Information:
Title
The mean number of Connect sessions per client/couple implemented by participating staff (at each agency) in the prior 6 months
Time Frame
18 months
Secondary Outcome Measure Information:
Title
To test whether key variables mediate adoption outcomes (e.g. staff attitudes and opinions towards programming and technology).
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be eligible for the study, CBOs must have reported that they had 501c3 status; provided at least a minimum level of direct contact HIV prevention services to clientele; and that their target population for services included heterosexual men and women. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan S. Witte, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Social Intervention Group
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25208569
Citation
Witte SS, Wu E, El-Bassel N, Hunt T, Gilbert L, Medina KP, Chang M, Kelsey R, Rowe J, Remien R. Implementation of a couple-based HIV prevention program: a cluster randomized trial comparing manual versus Web-based approaches. Implement Sci. 2014 Sep 11;9:116. doi: 10.1186/s13012-014-0116-x.
Results Reference
derived

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Using Multimedia Technologies to Disseminate an HIV Prevention

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