HIV InfectionsPhase 3NCT00289939
Reducing HIV & Domestic Violence Risk in Women Offenders
A Phase 3 study testing Motivational interviewing to reduce risk for HIV and DV in people with HIV Infections and Domestic Violence, run by Multnomah County Health Department at 1 site in United States.
Trial summary
The long-term goal of this work is to reduce the prevalence of HIV and domestic violence among women at risk by encouraging self-protective behaviors. To obtain this goal, Multnomah County Health Department and Oregon Department of Human Services have conducted a randomized trial of an intervention to prevent HIV and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Domestic Violence, Sexually Transmitted Diseases
- What is being tested?
- Motivational interviewing to reduce risk for HIV and DV
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 530 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Jan 2005
- Phase
- Phase 3
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women
- who were 18 years or older
- who had been in jail or prison in the past year or who were currently on parole or probation
- who had engaged in HIV-related risk behaviors (injection drug use, crack use, intercourse with a male injection drug user, exchanging sex, or having had ten or more sexual partners) in the past year
Who cannot join
- they were unable to give informed consent
- they were HIV positive at the time of screening for enrollment
- they reported highly unstable living conditions at screening
Trial locations and contacts
1 site in 1 country.
About this study
The long-term goal of this work is to reduce the prevalence of HIV and domestic violence among women at risk by encouraging self-protective behaviors. To obtain this goal, Multnomah County Health Department and Oregon Department of Human Services have conducted a randomized trial of an intervention to prevent HIV and domestic violence among women who have recent criminal justice involvement and who are at risk for HIV infection.
Women enrolled in the study were randomly assigned to one of three study conditions:
Read more
- Group 1: these women received information on local resources addressing HIV prevention, domestic violence, and life stability issues; they did not receive any counseling sessions as part of the study itself.
- Group 2: these women received up to ten supportive counseling sessions based on the techniques of motivational interviewing. These sessions aimed to reduce HIV risk and to improve life stability.
- Group 3: these women received up to ten supportive counseling sessions based on motivational interviewing. These sessions aimed to reduce risk for HIV and domestic violence and to improve life stability.
The primary hypotheses of this study were:
- 1. Supportive counseling (motivational interviewing) addressing HIV prevention and increased life stability will lead to reductions of HIV risk behavior among women enrolled in the study.
- 2. Supportive counseling (motivational interviewing) addressing domestic violence prevention, HIV prevention, and increased life stability, will bring about reductions in experiences of domestic violence and a reduction of HIV risk among these women.
- 3. The supportive counseling received in this study will enhance these women's self-efficacy, self-esteem, and psychological well-being.
Women in all three experimental groups were interviewed at the beginning of the study and again after 4, 7, and 10 months. These assessment interviews asked questions about: HIV risk; experiences of domestic violence; and life stability issues such as education, employment, and housing; and included biological testing for HIV and sexually transmitted diseases. Women in Group 2 and Group 3 participated in up to 10 sessions of supportive counseling (motivational interviewing) between the time of enrollment and the 4-month interviews.
- Being tested
- Motivational interviewing to reduce risk for HIV and DV
- Keywords
- women, women's health, HIV, risk factors, risk behaviors, prevention, motivational interviewing, domestic violence, partner violence, behavioral trial, community justice, criminal justice
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing to reduce risk for HIV and DVBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
unprotected sex
injection drug use
intimate partner violence
violence from others
Secondary outcomes (6)
self-esteem
anxiety
depression
housing stability
employment
education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startSep 2000
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 530 participants
Sponsor and investigators
- Lead sponsor
- Multnomah County Health Department
- Sponsor type
- Other government
- Collaborators
- Department of Human Services, Oregon
- Investigators
- Michael J. Stark, Ph.D., Principal investigator, Multnomah County Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289939
- Sponsor's protocol ID
- R01DA012572
- Status last verified
- Jul 2005
- First submitted
- 9 Feb 2006
- Last updated
- 28 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV & Domestic Violence Risk in Women Offenders
- ClinicalTrials.gov ID
- NCT00289939
- Acronym / sponsor ID
- R01DA012572
- Keywords
- women, women's health, HIV, risk factors, risk behaviors, prevention, motivational interviewing, domestic violence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants
- Lead sponsor
- Multnomah County Health DepartmentOther government
- Collaborators
- Department of Human Services, Oregon
- Study start
- Sep 2000
- Study completion
- Jan 2005
- First posted
- 10 Feb 2006 (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.
The long-term goal of this work is to reduce the prevalence of HIV and domestic violence among women at risk by encouraging self-protective behaviors. To obtain this goal, Multnomah County Health Department and Oregon Department of Human Services have conducted a randomized trial of an intervention to prevent HIV and domestic violence among women who have recent criminal justice involvement and who are at risk for HIV infection.
Women enrolled in the study were randomly assigned to one of three study conditions:
- Group 1: these women received information on local resources addressing HIV prevention, domestic violence, and life stability issues; they did not receive any counseling sessions as part of the study itself.
- Group 2: these women received up to ten supportive counseling sessions based on the techniques of motivational interviewing. These sessions aimed to reduce HIV risk and to improve life stability.
- Group 3: these women received up to ten supportive counseling sessions based on motivational interviewing. These sessions aimed to reduce risk for HIV and domestic violence and to improve life stability.
The primary hypotheses of this study were:
- 1. Supportive counseling (motivational interviewing) addressing HIV prevention and increased life stability will lead to reductions of HIV risk behavior among women enrolled in the study.
- 2. Supportive counseling (motivational interviewing) addressing domestic violence prevention, HIV prevention, and increased life stability, will bring about reductions in experiences of domestic violence and a reduction of HIV risk among these women.
- 3. The supportive counseling received in this study will enhance these women's self-efficacy, self-esteem, and psychological well-being.
Women in all three experimental groups were interviewed at the beginning of the study and again after 4, 7, and 10 months. These assessment interviews asked questions about: HIV risk; experiences of domestic violence; and life stability issues such as education, employment, and housing; and included biological testing for HIV and sexually transmitted diseases. Women in Group 2 and Group 3 participated in up to 10 sessions of supportive counseling (motivational interviewing) between the time of enrollment and the 4-month interviews.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women
- who were 18 years or older
- who had been in jail or prison in the past year or who were currently on parole or probation
- who had engaged in HIV-related risk behaviors (injection drug use, crack use, intercourse with a male injection drug user, exchanging sex, or having had ten or more sexual partners) in the past year
Key exclusion criteria (3 listed)
- they were unable to give informed consent
- they were HIV positive at the time of screening for enrollment
- they reported highly unstable living conditions at screening
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 |
|---|---|---|
| Motivational interviewing to reduce risk for HIV and DV | Behavioural | – |
Primary outcome
unprotected sex
injection drug use
intimate partner violence
violence from others
6 secondary outcomes
self-esteem
anxiety
depression
housing stability
employment
education
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 28 Feb 2006.
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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.
Michael J. Stark, Ph.D. principal investigator
Multnomah County Health Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motivational interviewing to reduce risk for HIV and DV in people with HIV Infections and Domestic Violence, run by Multnomah County Health Department 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 3 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 28 Feb 2006. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
unprotected sex. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2006.