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NCT01172704 · ClinicalTrials.gov registry record · Phase 2
HIV/AIDS, Severe Mental Illness and Homelessness
A Phase 2 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT01172704: Completed Phase 2 study, sponsored by Boston Medical Center.
NCT01172704 is a Phase 2 study that has completed, run by Boston Medical Center. The registered enrollment target is 240 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01172704, a Phase 2 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study Summary
This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention \[Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)\]. The study setting is a large urban safety net Medical Center and outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions + booster) was initially developed as the experimental condition in an R34 pilot project which demonstrated its feasibility and promise. For the proposed project, the investigators will recruit a larger sample which includes men and women with and without HIV, from various ethnic and racial groups, sexual orientations and housing arrangements, as well as a range of psychiatric disorders and functional capacities. In this way the investigators can more rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a sub-study after the 6 month follow-up to examine the impact at 12 months of an additional booster session for SB-MI participants. The investigators specific aims are: 1. To examine the effectiveness of a brief, tailored primary and secondary risk reduction strategy to CAU for people with serious mental illness. The desired outcomes include: * Decreased frequency of risk behaviors (number of partners, number of encounters) * Increased use of barrier precautions and IV needle cleaning * Positive changes in information and motivation, as well as risk behaviors * Increased HIV Counseling and Testing for those who do not know their HIV status 2. To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½ of participants randomized to SB-MI. The primary outcome will be: * Decreased frequency of risk behaviors and increased use of barrier precautions at the 12 month follow-up
Primary Outcome
Mean Changes from baseline to follow-ups at 6 and 12 months for constructs of the IMB (Information Motivation Behavior) Model will be larger for participants randomized to the SB-MI condition compared to CAU.
Interventions
- BEHAVIORAL Skills Building - Motivational Interviewing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2010-10 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT01172704 record still lists
NCT01172704 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 1 intervention - of which Skills Building - Motivational Interviewing is the first listed.
NCT01172704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01172704 about?
NCT01172704 is a clinical study titled "HIV/AIDS, Severe Mental Illness and Homelessness". This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention \[Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)\]. The...
What is the current status of trial NCT01172704?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2010-10. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01172704?
The interventions under investigation include: Skills Building - Motivational Interviewing (BEHAVIORAL).
Who is sponsoring clinical trial NCT01172704?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01172704's enrollment target sits among peer trials
240 239th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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