NCT01863537

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
253

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

4.3 years

First QC Date

May 20, 2013

Last Update Submit

July 29, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

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

    18 months

Secondary Outcomes (1)

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

    18 months

Study Arms (2)

Intervention

EXPERIMENTAL

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;

Behavioral: Multimedia Connect

Traditional Connect

ACTIVE COMPARATOR

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.

Behavioral: Traditional Connect

Interventions

Intervention
Traditional Connect

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Social Intervention Group

New York, New York, 10027, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Susan S. Witte, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associatge Professor

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 29, 2013

Study Start

May 1, 2007

Primary Completion

September 1, 2011

Study Completion

June 1, 2013

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations