Sexual Risk BehaviorTHRIVENCT01395979
HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories
A study testing Cognitive Processing Therapy for Sexual Risk, Supportive Psychotherapy and Sexual Risk Reduction Intervention in people with Sexual Risk Behavior and Childhood Sexual Abuse, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
Brief Summary: The specific aims of this study are: 1. To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual abuse… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sexual Risk Behavior, Childhood Sexual Abuse, Stress Disorders, Post-Traumatic
- What is being tested?
- Cognitive Processing Therapy for Sexual Risk, Supportive Psychotherapy and Sexual Risk Reduction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2011to May 2017
- 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 MSM.
- Reports history of CSA (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 or with a person 10 years older).
- Reports >1 episode of unprotected anal or vaginal intercourse within the past three months.
- Reports HIV-negative status confirmed by rapid HIV test.
- Is capable of completing and fully understanding the informed consent process and the study procedures.
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 (e.g. bipolar disorder; any psychotic disorder).
- Inability to complete informed consent process (e.g. substantial cognitive impairment, inadequate English language skills).
- Has received CPT for PTSD within the past 12 months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114-2919
The Fenway Institute
Boston, Massachusetts, 02215
University of Miami
Coral Gables, Florida, 33124-0751
About this study
Brief Summary: The specific aims of this study are:
- To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual abuse (CSA). The primary outcome is reduction in unprotected anal/vaginal intercourse (number and proportion) with serodiscordant partners. The investigators will also examine the intervention effect on CSA-related trauma symptom severity and cognitions and behaviors.
- To examine the degree to which intervention-related reductions in sexual risk behavior are mediated by reductions in CSA-related symptom severity, cognitions, and behaviors.
- To examine the degree to which the intervention reduces incident sexually transmitted infections (STIs) during the study period, as well as to explore additional potential moderators and mediators of intervention efficacy.
Read more
Study hypotheses:
- For the primary outcome, the investigators hypothesize that those who receive the intervention will have reduced transmission-risk behavior.
- For the secondary outcome, the investigators hypothesize that those who receive the intervention will have reduced trauma symptom severity (cognitions and behaviors).
Read the detailed description
The prevalence of HIV among men who have sex with men (MSM) is estimated at an alarming 19% domestically (CDC 2010), rates comparable to endemic settings in certain regions of sub-Saharan Africa where approximately 20% of the adult population is HIV infected. Studies have also demonstrated a staggeringly high prevalence of childhood sexual abuse (CSA) in MSM, and shown an association between CSA and HIV risk in MSM. A successful intervention for MSM with a CSA history to prevent HIV has the potential to avert infections among some of the riskiest members of the most HIV vulnerable group in the U.S. Notwithstanding the ability of the existing HIV prevention interventions to show reductions in sexual risk taking, the recent successes of chemoprophylaxis, current policy initiatives, and empirically supported recommendations, all support development of combination prevention interventions that can specify multiple prevention targets, address related risk factors and barriers, and are grounded in a community context. The pathways from CSA to adult sexual risk behavior are varied and complex and this complexity is appropriately addressed in individual-based interventions where empirically supported interventions for CSA related trauma were efficacy tested. The development of an integrated prevention intervention that utilizes cognitive behavioral technologies to address co-occurring and interfering CSA and sexual risk represents a novel and largely untested innovative application that is theoretically designed to address sexual risk directly and indirectly through reductions in CSA-related trauma symptoms. The flexibility of integrated and combination prevention programs has the potential to support triage of MSM with particular risk profiles to the programs that best meet their prevention needs.
This two-arm RCT is designed to test the efficacy of a psycho-social intervention that addresses intersecting epidemics among MSM, HIV and CSA. The experimental condition integrates sexual risk reduction counseling with Cognitive Processing Therapy for Sexual Risk (CPT-SR). CPT-SR has been specifically piloted on MSM with CSA histories and sexual risk to reduce interfering negative CSA-related thoughts about self, to more accurately appraise sexual risk, and to decrease avoidance of sexual safety considerations through rehearsals of sexual safety behaviors. The active and time-matched comparison condition is risk reduction counseling plus supportive psychotherapy. The investigators will randomize HIV-uninfected MSM who report a history of CSA and multiple recent sexual risk episodes for HIV (unprotected anal/vaginal intercourse) across two sites (Boston and Miami). The primary outcome will be self-reported sexual risk taking as assessed via a computer-based questionnaire. Secondary outcomes include trauma symptom severity, both cognitive and behavioral. Study assessment points are at baseline, 3 (post treatment), 6, 9, and 12-month follow-ups.
- Being tested
- Cognitive Processing Therapy for Sexual Risk, Supportive Psychotherapy, Sexual Risk Reduction Intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy for Sexual RiskBehavioural
Also called CPT-SR
Eight weekly sessions, 4 modules.
Supportive PsychotherapyBehavioural
Also called TMC
Eight weekly sessions
Sexual Risk Reduction InterventionBehavioural
Two weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy for Sexual Risk (CPT-SR) | Experimental | The CPT-SR condition will be comprised of 10 individual therapy sessions fully integrating sexual risk reduction counseling into cognitive therapy for sexual abuse-related trauma. Receives: Behavioral: Cognitive Processing Therapy for Sexual Risk; Behavioral: Sexual Risk Reduction Intervention |
| Time-Matched Control (TMC) | Active comparator | The TMC will be comprised of sexual risk reduction counseling/education and supportive psychotherapy. Receives: Behavioral: Supportive Psychotherapy; Behavioral: Sexual Risk Reduction Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in Sexual Risk Behavior for HIV Acquisition
Number of unprotected (no condom was used) insertive or receptive anal or vaginal intercourse acts reported in the past 3 months with casual partners or with partners with unknown or positive HIV status.
Measured: Baseline, (2 weeks post-baseline pre-randomization), 3,6, 9, and 12 month follow ups
Secondary outcomes (1)
Changes from Baseline in Trauma Symptom Severity
Davidson Trauma Scale which has been correlated with measures of Post-Traumatic Stress Disorder (PTSD) severity, depression, and general anxiety, and discriminated well between traumatized individuals with and without PTSD.
Measured: Baseline assessment, 3, 6, and 9-month follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual Risk BehaviorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fenway Community Health, University of Miami
- Responsible party
- Principal investigator, Conall O'Cleirigh, Massachusetts General Hospital
- Investigators
- Conall O'Cleirigh, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395979
- Sponsor's protocol ID
- R01MH095624-01
- Acronym
- THRIVE
- Status last verified
- Mar 2018
- First submitted
- 11 Jul 2011
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Batchelder AW, Fitch C, Feinstein BA, Thiim A, O'Cleirigh C. Psychiatric, Substance Use, and Structural Disparities Between Gay and Bisexual Men with Histories of Childhood Sexual Abuse and Recent Sexual Risk Behavior. Arch Sex Behav. 2021 Oct;50(7):2861-2873. doi: 10.1007/s10508-021-02037-1. Epub 2021 Oct 21.
PubMed 34676467Batchelder AW, Choi K, Dale SK, Pierre-Louis C, Sweek EW, Ironson G, Safren SA, O'Cleirigh C. Effects of syndemic psychiatric diagnoses on health indicators in men who have sex with men. Health Psychol. 2019 Jun;38(6):509-517. doi: 10.1037/hea0000724. Epub 2019 Apr 11.
PubMed 30973745
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories
- ClinicalTrials.gov ID
- NCT01395979
- Acronym / sponsor ID
- THRIVE / R01MH095624-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Fenway Community Health, University of Miami
- Study start
- Oct 2011 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Jul 2011 (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.
Brief Summary: The specific aims of this study are:
- To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual abuse (CSA). The primary outcome is reduction in unprotected anal/vaginal intercourse (number and proportion) with serodiscordant partners. The investigators will also examine the intervention effect on CSA-related trauma symptom severity and cognitions and behaviors.
- To examine the degree to which intervention-related reductions in sexual risk behavior are mediated by reductions in CSA-related symptom severity, cognitions, and behaviors.
- To examine the degree to which the intervention reduces incident sexually transmitted infections (STIs) during the study period, as well as to explore additional potential moderators and mediators of intervention efficacy.
Study hypotheses:
- For the primary outcome, the investigators hypothesize that those who receive the intervention will have reduced transmission-risk behavior.
- For the secondary outcome, the investigators hypothesize that those who receive the intervention will have reduced trauma symptom severity (cognitions and behaviors).
Detailed description
The prevalence of HIV among men who have sex with men (MSM) is estimated at an alarming 19% domestically (CDC 2010), rates comparable to endemic settings in certain regions of sub-Saharan Africa where approximately 20% of the adult population is HIV infected. Studies have also demonstrated a staggeringly high prevalence of childhood sexual abuse (CSA) in MSM, and shown an association between CSA and HIV risk in MSM. A successful intervention for MSM with a CSA history to prevent HIV has the potential to avert infections among some of the riskiest members of the most HIV vulnerable group in the U.S. Notwithstanding the ability of the existing HIV prevention interventions to show reductions in sexual risk taking, the recent successes of chemoprophylaxis, current policy initiatives, and empirically supported recommendations, all support development of combination prevention interventions that can specify multiple prevention targets, address related risk factors and barriers, and are grounded in a community context. The pathways from CSA to adult sexual risk behavior are varied and complex and this complexity is appropriately addressed in individual-based interventions where empirically supported interventions for CSA related trauma were efficacy tested. The development of an integrated prevention intervention that utilizes cognitive behavioral technologies to address co-occurring and interfering CSA and sexual risk represents a novel and largely untested innovative application that is theoretically designed to address sexual risk directly and indirectly through reductions in CSA-related trauma symptoms. The flexibility of integrated and combination prevention programs has the potential to support triage of MSM with particular risk profiles to the programs that best meet their prevention needs.
This two-arm RCT is designed to test the efficacy of a psycho-social intervention that addresses intersecting epidemics among MSM, HIV and CSA. The experimental condition integrates sexual risk reduction counseling with Cognitive Processing Therapy for Sexual Risk (CPT-SR). CPT-SR has been specifically piloted on MSM with CSA histories and sexual risk to reduce interfering negative CSA-related thoughts about self, to more accurately appraise sexual risk, and to decrease avoidance of sexual safety considerations through rehearsals of sexual safety behaviors. The active and time-matched comparison condition is risk reduction counseling plus supportive psychotherapy. The investigators will randomize HIV-uninfected MSM who report a history of CSA and multiple recent sexual risk episodes for HIV (unprotected anal/vaginal intercourse) across two sites (Boston and Miami). The primary outcome will be self-reported sexual risk taking as assessed via a computer-based questionnaire. Secondary outcomes include trauma symptom severity, both cognitive and behavioral. Study assessment points are at baseline, 3 (post treatment), 6, 9, and 12-month follow-ups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy for Sexual Risk (CPT-SR) | Experimental | Behavioral: Cognitive Processing Therapy for Sexual Risk, Behavioral: Sexual Risk Reduction InterventionThe CPT-SR condition will be comprised of 10 individual therapy sessions fully integrating sexual risk reduction counseling into cognitive therapy for sexual abuse-related trauma. |
| Time-Matched Control (TMC) | Active comparator | Behavioral: Supportive Psychotherapy, Behavioral: Sexual Risk Reduction InterventionThe TMC will be comprised of sexual risk reduction counseling/education and supportive psychotherapy. |
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 MSM.
- Reports history of CSA (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 or with a person 10 years older).
- Reports >1 episode of unprotected anal or vaginal intercourse within the past three months.
- Reports HIV-negative status confirmed by rapid HIV test.
- Is capable of completing and fully understanding the informed consent process and the study procedures.
Key exclusion criteria (4 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 (e.g. bipolar disorder; any psychotic disorder).
- Inability to complete informed consent process (e.g. substantial cognitive impairment, inadequate English language skills).
- Has received CPT for PTSD within the past 12 months.
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 |
|---|---|---|
| Cognitive Processing Therapy for Sexual RiskAlso: CPT-SREight weekly sessions, 4 modules. | Behavioural | Cognitive Processing Therapy for Sexual Risk (CPT-SR) |
| Supportive PsychotherapyAlso: TMCEight weekly sessions | Behavioural | Time-Matched Control (TMC) |
| Sexual Risk Reduction InterventionTwo weekly sessions. | Behavioural | Cognitive Processing Therapy for Sexual Risk (CPT-SR), Time-Matched Control (TMC) |
Primary outcome
Changes from Baseline in Sexual Risk Behavior for HIV Acquisition
Time frame: Baseline, (2 weeks post-baseline pre-randomization), 3,6, 9, and 12 month follow ups
Number of unprotected (no condom was used) insertive or receptive anal or vaginal intercourse acts reported in the past 3 months with casual partners or with partners with unknown or positive HIV status.
1 secondary outcome
Changes from Baseline in Trauma Symptom Severity
Time frame: Baseline assessment, 3, 6, and 9-month follow-up assessments
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 30 Mar 2018.
- Derived from this study: PubMed 34676467Batchelder AW, Fitch C, Feinstein BA, Thiim A, O'Cleirigh C. Psychiatric, Substance Use, and Structural Disparities Between Gay and Bisexual Men with Histories of Childhood Sexual Abuse and Recent Sexual Risk Behavior. Arch Sex Behav. 2021 Oct;50(7):2861-2873. doi: 10.1007/s10508-021-02037-1. Epub 2021 Oct 21.
- Derived from this study: PubMed 30973745Batchelder AW, Choi K, Dale SK, Pierre-Louis C, Sweek EW, Ironson G, Safren SA, O'Cleirigh C. Effects of syndemic psychiatric diagnoses on health indicators in men who have sex with men. Health Psychol. 2019 Jun;38(6):509-517. doi: 10.1037/hea0000724. Epub 2019 Apr 11.
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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 O'Cleirigh, Ph.D. principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy for Sexual Risk, Supportive Psychotherapy and Sexual Risk Reduction Intervention in people with Sexual Risk Behavior and Childhood Sexual Abuse, run by Massachusetts General Hospital at 3 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 4 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Changes from Baseline in Sexual Risk Behavior for HIV Acquisition (time frame: Baseline, (2 weeks post-baseline pre-randomization), 3,6, 9, and 12 month follow ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01395979, which also lists 2 linked publications.
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 30 Mar 2018.