HIV InfectionNCT01863537
Using Multimedia Technologies to Disseminate an HIV Prevention
A study testing Multimedia Connect and Traditional Connect in people with HIV Infection, run by Columbia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Multimedia Connect and Traditional Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Social Intervention Group
New York, New York, 10027
About this study
Official title: Using Multimedia Technologies to Disseminate an HIV Prevention Program for Couples
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.
- Conditions
- HIV Infection
- Being tested
- Multimedia Connect, Traditional Connect
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia ConnectBehavioural
Traditional ConnectBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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. Receives: Behavioral: Traditional Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean number of Connect sessions per client/couple implemented by participating staff (at each agency) in the prior 6 months
Measured: 18 months
Secondary outcomes (1)
To test whether key variables mediate adoption outcomes (e.g. staff attitudes and opinions towards programming and technology).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2007
- Primary completionSep 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Susan Witte, Columbia University
- Investigators
- Susan S. Witte, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863537
- Sponsor's protocol ID
- AAAC5642
- Other IDs
- R01MH080659
- Status last verified
- Jul 2013
- First submitted
- 20 May 2013
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25208569
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Multimedia Technologies to Disseminate an HIV Prevention Program for Couples
- ClinicalTrials.gov ID
- NCT01863537
- Acronym / sponsor ID
- AAAC5642
- Conditions
- HIV Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multimedia ConnectMultimedia 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; |
| Traditional Connect | Active comparator | Behavioral: Traditional ConnectThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimedia Connect | Behavioural | Intervention |
| Traditional Connect | Behavioural | Traditional Connect |
Primary outcome
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
1 secondary outcome
To test whether key variables mediate adoption outcomes (e.g. staff attitudes and opinions towards programming and technology).
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
- Derived from this study: PubMed 25208569Witte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan S. Witte, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia Connect and Traditional Connect in people with HIV Infection, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013.