|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00356291 |
|
Date of registration:
|
21/07/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Improving HIV Prevention Skills in People With Serious Mental Illnesses
|
|
Scientific title:
|
HIV Prevention for the Mentally Ill: Motivation-Skills |
|
Date of first enrolment:
|
April 2007 |
|
Target sample size:
|
53 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00356291 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Stephen M. Brady, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Boston University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Meets criteria for a serious and persistent mental illness (as defined by the
Massachusetts Department of Mental Health)
- English-speaking
- Engagement in HIV risk behavior within 3 months prior to study entry
- Ability to keep study-related appointments
Exclusion Criteria:
- Unstable mental status
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV/AIDS
|
|
Intervention(s)
|
|
Behavioral: Skill-Building (SB)
|
|
Behavioral: Skill-Building (SB) plus Motivational Interviewing
|
|
Primary Outcome(s)
|
|
Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning
[Time Frame: Measured at Months 3 and 6]
|
|
Access of HIV counseling and testing
[Time Frame: Measured at Months 3 and 6]
|
|
Communication and negotiation skills
[Time Frame: Measured at Months 3 and 6]
|
|
Timeline Followback (TLFB) measures of HIV risk behaviors and use of HIV risk prevention strategies (including use of male and female condoms, dental dams, and recommended intravenous needle-cleaning)
[Time Frame: Measured at Months 3 and 6]
|
|
Secondary Outcome(s)
|
|
HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ)
[Time Frame: Measured at Months 3 and 6]
|
|
Multidimensional Condom Attitude Scale (MCAS)
[Time Frame: Measured at Months 3 and 6]
|
|
Secondary ID(s)
|
|
R34MH075644
|
|
DAHBR 9A-ASNM
|
|
R34 MH75644
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|