Using Multimedia Technologies to Disseminate an HIV Prevention

NCT ID: NCT01863537

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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;

Group Type EXPERIMENTAL

Multimedia Connect

Intervention Type BEHAVIORAL

Traditional Connect

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.

Group Type ACTIVE_COMPARATOR

Traditional Connect

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multimedia Connect

Intervention Type BEHAVIORAL

Traditional Connect

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susan Witte

Associatge Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan S. Witte, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbia University Social Intervention Group

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25208569 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH080659

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAC5642

Identifier Type: -

Identifier Source: org_study_id