Risk ReductionNCT00797654
HIV Prevention and Trauma Treatment in Men Who Have Sex With Men and Who Have a History of Sexual Abuse
A study testing Information-motivation-behavior skills and cognitive processing therapy and Pre and Post HIV-Test Counseling in people with Risk Reduction, run by Fenway Community Health at 2 sites in United States.
Trial summary
This study will develop a therapy for men who have sex with men who also have a history of childhood sexual abuse to reduce behaviors that put them at a high risk of HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Risk Reduction
- What is being tested?
- Information-motivation-behavior skills and cognitive processing therapy and Pre and Post HIV-Test Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to May 2011
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identifies as a biological man who has sex with men
- Reports history of childhood sexual abuse (sexual contact before the age of 13 with an adult or person 5 years older or sexual contact with the threat of force or harm between the ages of 13 and 16, inclusive, with a person 10 years older)
- Reports unprotected anal or vaginal intercourse within the past 3 months
- HIV-negative serostatus
- Able to understand English
Who cannot join
- All episodes of unprotected anal or vaginal intercourse occurred with only a single, primary HIV-negative partner
- Significant mental health diagnosis requiring immediate treatment, such as acute major depression, panic disorder, or any psychotic disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fenway Community Health
Boston, Massachusetts, 02215
Fenway Health
Boston, Massachusetts, 02215
About this study
Official title: Integrated HIV Prevention and Trauma Treatment in MSM With Sexual Abuse History (Project THRIVE)
This study will develop a therapy for men who have sex with men who also have a history of childhood sexual abuse to reduce behaviors that put them at a high risk of HIV infection.
Read the detailed description
Men who have sex with men (MSM) represent the largest group of new HIV infections. Rates of childhood sexual abuse (CSA) in MSM have been estimated to be higher than in the rest of the population, with some researchers estimating that 37% of all MSM have experienced CSA. CSA in MSM is associated with both higher rates of HIV risk behavior and higher rates of HIV infection. Treatments for preventing HIV are also less likely to be effective in MSM with a history of CSA, and these individuals tend to have higher rates of depression, anxiety, substance abuse, and post-traumatic stress disorder (PTSD) symptoms. This study will create and then test a new HIV prevention therapy that addresses both HIV risk behaviors and the co-occurring psychological health problems in MSM with a history of CSA.
This study includes a pilot phase and an experimental phase. In the pilot phase, the therapeutic treatment will be developed based on elements of successful interventions for reducing sexual risk-taking behaviors and PTSD symptoms. Information-motivation-behavioral (IMB) skills training for sexual risk reduction will be the basis for one of two treatment components, and it is expected to last for two 50-minute sessions. This intervention will include addressing knowledge about issues surrounding sexual risk, using motivational interviewing to address goals and self-efficacy, and providing strategies for behavioral change. Cognitive processing therapy (CPT) for CSA will be the basis for the other component and is expected to last for eight 50-minute sessions. Elements of this intervention will include identifying sexual abuse events, learning how to identify cognitive distortions, and learning processes to challenge and process these distortions.
During the pilot phase, approximately 10 participants will undergo the new treatment. After completing the treatment sessions, participants will undergo exit interviews, in which researchers will solicit feedback about the strengths and weaknesses of the treatment. This feedback will be used to fine tune the treatment.
During the second phase of the study, approximately 50 individuals will be randomly assigned to receive either HIV testing with pre/post-test counseling alone or in combination with the newly developed treatment. The experimental, integrated treatment will be administered over 10 individual therapy sessions comprised of sexual risk reduction counseling and cognitive therapy.
All participants will undergo assessments at enrollment and after treatment (or approximately 3 months after enrollment in comparator group), and at follow-up visits 6 and 9 months after enrollment. These assessments will measure sexual risk behaviors, PTSD symptoms, distress, social support, and substance abuse. Brief questionnaires about sexual behavior and measures of distress will be administered during the integrated treatment sessions.
- Conditions
- Risk Reduction
- Being tested
- Information-motivation-behavior skills and cognitive processing therapy, Pre and Post HIV-Test Counseling
- Keywords
- Sexual Risks for HIV, Psychosocial Sequelae Relating to Childhood Sexual Abuse
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information-motivation-behavior skills and cognitive processing therapyBehavioural
Treatment will include elements from effective interventions for reducing risky sexual behaviors and reducing post-traumatic stress disorder (PTSD) symptoms.
Pre and Post HIV-Test CounselingBehavioural
Treatments are aimed at assessing and reducing behaviors that put participants at high risk of HIV infection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive pre and post HIV-test counseling and an information-motivation-behavior skills training combined with cognitive processing therapy Receives: Behavioral: Information-motivation-behavior skills and cognitive processing therapy; Behavioral: Pre and Post HIV-Test Counseling |
| 2 | Active comparator | Participants will receive pre and post HIV-test counseling Receives: Behavioral: Pre and Post HIV-Test Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported sexual risk taking
For both the Treatment (Cognitive Processing Therapy with Information Motivation Behavior) and Control arms, participants will self-report sexual risk taking at baseline, 3-month post baseline, and at 6 and 9-month follow-ups (after enrollment).
Measured: Measured pre- and post-treatment and after 6 and 9 months
Secondary outcomes (1)
Reductions in negative effects of trauma, with cognitive and behavioral variables tested as potential mediators of treatment outcome
As with the baseline assessment, the Davidson Post-Traumatic Stress Disorder scale, and the MINI Neuro-psychiatric Interview for PTSD will be administered by an Independent Assessor who will be blind to participant group assignment.
Measured: Measured pre- and post-treatment and after 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk ReductionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenway Community Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Conall O'Cleirigh, Fenway Community Health
- Investigators
- Conall M. O'Cleirigh, PhD, Principal investigator, Fenway Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797654
- Sponsor's protocol ID
- R34MH081760-02
- Other IDs
- R34MH081760-02
- Status last verified
- Aug 2016
- First submitted
- 24 Nov 2008
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated HIV Prevention and Trauma Treatment in MSM With Sexual Abuse History (Project THRIVE)
- ClinicalTrials.gov ID
- NCT00797654
- Acronym / sponsor ID
- R34MH081760-02
- Conditions
- Risk Reduction
- Keywords
- Sexual Risks for HIV, Psychosocial Sequelae Relating to Childhood Sexual Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fenway Community HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 25 Nov 2008 (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 study will develop a therapy for men who have sex with men who also have a history of childhood sexual abuse to reduce behaviors that put them at a high risk of HIV infection.
Detailed description
Men who have sex with men (MSM) represent the largest group of new HIV infections. Rates of childhood sexual abuse (CSA) in MSM have been estimated to be higher than in the rest of the population, with some researchers estimating that 37% of all MSM have experienced CSA. CSA in MSM is associated with both higher rates of HIV risk behavior and higher rates of HIV infection. Treatments for preventing HIV are also less likely to be effective in MSM with a history of CSA, and these individuals tend to have higher rates of depression, anxiety, substance abuse, and post-traumatic stress disorder (PTSD) symptoms. This study will create and then test a new HIV prevention therapy that addresses both HIV risk behaviors and the co-occurring psychological health problems in MSM with a history of CSA.
This study includes a pilot phase and an experimental phase. In the pilot phase, the therapeutic treatment will be developed based on elements of successful interventions for reducing sexual risk-taking behaviors and PTSD symptoms. Information-motivation-behavioral (IMB) skills training for sexual risk reduction will be the basis for one of two treatment components, and it is expected to last for two 50-minute sessions. This intervention will include addressing knowledge about issues surrounding sexual risk, using motivational interviewing to address goals and self-efficacy, and providing strategies for behavioral change. Cognitive processing therapy (CPT) for CSA will be the basis for the other component and is expected to last for eight 50-minute sessions. Elements of this intervention will include identifying sexual abuse events, learning how to identify cognitive distortions, and learning processes to challenge and process these distortions.
During the pilot phase, approximately 10 participants will undergo the new treatment. After completing the treatment sessions, participants will undergo exit interviews, in which researchers will solicit feedback about the strengths and weaknesses of the treatment. This feedback will be used to fine tune the treatment.
During the second phase of the study, approximately 50 individuals will be randomly assigned to receive either HIV testing with pre/post-test counseling alone or in combination with the newly developed treatment. The experimental, integrated treatment will be administered over 10 individual therapy sessions comprised of sexual risk reduction counseling and cognitive therapy.
All participants will undergo assessments at enrollment and after treatment (or approximately 3 months after enrollment in comparator group), and at follow-up visits 6 and 9 months after enrollment. These assessments will measure sexual risk behaviors, PTSD symptoms, distress, social support, and substance abuse. Brief questionnaires about sexual behavior and measures of distress will be administered during the integrated treatment sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Information-motivation-behavior skills and cognitive processing therapy, Behavioral: Pre and Post HIV-Test CounselingParticipants will receive pre and post HIV-test counseling and an information-motivation-behavior skills training combined with cognitive processing therapy |
| 2 | Active comparator | Behavioral: Pre and Post HIV-Test CounselingParticipants will receive pre and post HIV-test counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Identifies as a biological man who has sex with men
- Reports history of childhood sexual abuse (sexual contact before the age of 13 with an adult or person 5 years older or sexual contact with the threat of force or harm between the ages of 13 and 16, inclusive, with a person 10 years older)
- Reports unprotected anal or vaginal intercourse within the past 3 months
- HIV-negative serostatus
- Able to understand English
Key exclusion criteria (2 listed)
- All episodes of unprotected anal or vaginal intercourse occurred with only a single, primary HIV-negative partner
- Significant mental health diagnosis requiring immediate treatment, such as acute major depression, panic disorder, or any psychotic disorder
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 |
|---|---|---|
| Information-motivation-behavior skills and cognitive processing therapyTreatment will include elements from effective interventions for reducing risky sexual behaviors and reducing post-traumatic stress disorder (PTSD) symptoms. | Behavioural | 1 |
| Pre and Post HIV-Test CounselingTreatments are aimed at assessing and reducing behaviors that put participants at high risk of HIV infection. | Behavioural | 1, 2 |
Primary outcome
Self-reported sexual risk taking
Time frame: Measured pre- and post-treatment and after 6 and 9 months
For both the Treatment (Cognitive Processing Therapy with Information Motivation Behavior) and Control arms, participants will self-report sexual risk taking at baseline, 3-month post baseline, and at 6 and 9-month follow-ups (after enrollment).
1 secondary outcome
Reductions in negative effects of trauma, with cognitive and behavioral variables tested as potential mediators of treatment outcome
Time frame: Measured pre- and post-treatment and after 6 and 9 months
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 9 Aug 2016.
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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.
Conall M. O'Cleirigh, PhD principal investigator
Fenway Community Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information-motivation-behavior skills and cognitive processing therapy and Pre and Post HIV-Test Counseling in people with Risk Reduction, run by Fenway Community Health at 2 sites 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 5 inclusion and 2 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 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Self-reported sexual risk taking (time frame: Measured pre- and post-treatment and after 6 and 9 months). 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 9 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.