HIV/AIDS, Severe Mental Illness and Homelessness
Public ClinicalTrials.gov record NCT01172704. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01172704
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 240 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 19 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Mar 31, 2015
- Completion
- Dec 31, 2015
- Last update posted
- Mar 31, 2016
2010 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01172704, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 31, 2016 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01172704 live on ClinicalTrials.gov.