HIVPhase 1/2NCT00186030
Reducing Risk and Trauma-Related Stress in Persons Living With HIV
A Phase 1/2 study testing HIV Skills-based Prevention in people with HIV and PTSD, run by Stanford University at 1 site in United States.
Trial summary
This two-year study tested the concept that an intervention, which reduces trauma-related symptoms among adults who are living with human immunodeficiency virus (HIV), are experiencing trauma-related stress symptoms, and engaging in behavior that facilitates HIV transmission, can reduce the transmission risk of (HIV). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- HIV Skills-based Prevention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Mar 2004
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- must be 18 years or older, must be HIV-positive
- report engaging in behavior that could put them at risk for HIV transmission during the past 3 months
- report experiencing one or more trauma-related symptoms (i.e., reexperiencing, hyperarousal, or avoidance) occurring within the past three months.
Who cannot join
- experience psychological symptoms or substance use problems so severe that it would impair their ability or the ability of others to participate in a group intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for AIDS Intervention Research (CAIR)
Milwaukee, Wisconsin, 53202
About this study
This two-year study tested the concept that an intervention, which reduces trauma-related symptoms among adults who are living with human immunodeficiency virus (HIV), are experiencing trauma-related stress symptoms, and engaging in behavior that facilitates HIV transmission, can reduce the transmission risk of (HIV). Our central premise was that by first treating trauma symptoms, we would enhance the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance.
The study aims were to:
- To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post-intervention and 3 months after the small group intervention sessions;
- To determine whether key variables moderate the intervention's effects. For instance, gender, age, ethnicity, or psychological distress (e.g., depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior; and
- To determine whether there is evidence that the theoretical mediator variables, which include trauma-related stress symptoms, self-efficacy, communication skills, and social support mediate the intervention's effects on outcomes. This information addresses the theoretical question of why the intervention works.
Read the detailed description
There are no published longitudinal studies examining the impact of traumatic events on risk behavior among HIV-positive men and women. As a result, we know very little about how stress, particularly trauma-related stress, influences HIV risk behavior. This study will be one of the first randomized studies to examine the efficacy of reducing HIV risk behavior by combining a trauma-focused stress reduction intervention with a standard HIV prevention skills intervention. This study is specifically targeting a low-income, urban population, a group that experiences a disproportionate rate of crime as well as HIV infection. Findings of the research will likely provide information on the relationship between trauma and risk behavior. Furthermore, this research can identify key issues related to stress, psychosocial factors, and overall health that will be relevant to investigate in future, larger-scale studies of HIV-positive as well as HIV-negative populations.
Individuals who reported living with HIV, engaging in HIV risk behavior in the past 3 months, experiencing a traumatic stressor and trauma-related symptoms in the past 3 months were assigned to one of three conditions: 1) standard HIV prevention skills; 2) standard HIV prevention skills + trauma-focused stress reduction skills training; or 3) trauma-focused stress reduction skills training.
- Being tested
- HIV Skills-based Prevention
- Keywords
- HIV, AIDS, PTSD, Prevention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Skills-based PreventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post-intervention and 3 months after the small group intervention sessions
Secondary outcomes (2)
To determine whether key variables moderate the intervention's effects. For instance, gender, age, ethnicity, or psychological distress (e.g., depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior.
To determine whether there is evidence that the theoretical mediator variables, which include trauma-related stress symptoms, self-efficacy, communication skills, and social support mediate the intervention's effects on outcomes. This information will
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2003
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Stanford 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Cheryl Gore-Felton, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186030
- Sponsor's protocol ID
- 5R03MH063643-02
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 6 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Risk and Trauma-Related Stress in Persons Living With HIV
- ClinicalTrials.gov ID
- NCT00186030
- Acronym / sponsor ID
- 5R03MH063643-02
- Keywords
- HIV, AIDS, PTSD, Prevention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 102 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Mar 2004
- First posted
- 16 Sep 2005 (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 two-year study tested the concept that an intervention, which reduces trauma-related symptoms among adults who are living with human immunodeficiency virus (HIV), are experiencing trauma-related stress symptoms, and engaging in behavior that facilitates HIV transmission, can reduce the transmission risk of (HIV). Our central premise was that by first treating trauma symptoms, we would enhance the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance.
The study aims were to:
- To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post-intervention and 3 months after the small group intervention sessions;
- To determine whether key variables moderate the intervention's effects. For instance, gender, age, ethnicity, or psychological distress (e.g., depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior; and
- To determine whether there is evidence that the theoretical mediator variables, which include trauma-related stress symptoms, self-efficacy, communication skills, and social support mediate the intervention's effects on outcomes. This information addresses the theoretical question of why the intervention works.
Detailed description
There are no published longitudinal studies examining the impact of traumatic events on risk behavior among HIV-positive men and women. As a result, we know very little about how stress, particularly trauma-related stress, influences HIV risk behavior. This study will be one of the first randomized studies to examine the efficacy of reducing HIV risk behavior by combining a trauma-focused stress reduction intervention with a standard HIV prevention skills intervention. This study is specifically targeting a low-income, urban population, a group that experiences a disproportionate rate of crime as well as HIV infection. Findings of the research will likely provide information on the relationship between trauma and risk behavior. Furthermore, this research can identify key issues related to stress, psychosocial factors, and overall health that will be relevant to investigate in future, larger-scale studies of HIV-positive as well as HIV-negative populations.
Individuals who reported living with HIV, engaging in HIV risk behavior in the past 3 months, experiencing a traumatic stressor and trauma-related symptoms in the past 3 months were assigned to one of three conditions: 1) standard HIV prevention skills; 2) standard HIV prevention skills + trauma-focused stress reduction skills training; or 3) trauma-focused stress reduction skills training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- must be 18 years or older, must be HIV-positive
- report engaging in behavior that could put them at risk for HIV transmission during the past 3 months
- report experiencing one or more trauma-related symptoms (i.e., reexperiencing, hyperarousal, or avoidance) occurring within the past three months.
Key exclusion criteria (1 listed)
- experience psychological symptoms or substance use problems so severe that it would impair their ability or the ability of others to participate in a group intervention
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 |
|---|---|---|
| HIV Skills-based Prevention | Behavioural | – |
Primary outcome
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post-intervention and 3 months after the small group intervention sessions
2 secondary outcomes
To determine whether key variables moderate the intervention's effects. For instance, gender, age, ethnicity, or psychological distress (e.g., depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior.
To determine whether there is evidence that the theoretical mediator variables, which include trauma-related stress symptoms, self-efficacy, communication skills, and social support mediate the intervention's effects on outcomes. This information will
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 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.
Cheryl Gore-Felton, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HIV Skills-based Prevention in people with HIV and PTSD, run by Stanford 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 3 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: stopped early, as of the sponsor's last update on 6 Oct 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post-intervention and 3 months after the small group intervention sessions. 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 6 Oct 2006; AzTrials last refreshed its copy on 7 Nov 2026.