## Protocol Section
### Identification Module
**NCT ID:** NCT01395979

**Acronym:** THRIVE

**Brief Title:** HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories

#### Organization Study ID Info
**ID:** R01MH095624-01
**Link:** https://reporter.nih.gov/quickSearch/R01MH095624-01
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2017-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-03-30

**Type:** ACTUAL

**Last Update Submit Date:** 2018-03-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-05

**Type:** ACTUAL

#### Start Date
**Date:** 2011-10

**Type:** ACTUAL

**Status Verified Date:** 2018-03

#### Study First Post Date
**Date:** 2011-07-18
**Type:** ESTIMATED
**Study First Submit Date:** 2011-07-11
**Study First Submit QC Date:** 2011-07-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Fenway Community Health

**Class:** OTHER

**Name:** University of Miami

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts General Hospital

#### Responsible Party

**Investigator Affiliation:** Massachusetts General Hospital

**Investigator Full Name:** Conall O'Cleirigh

**Investigator Title:** Ph.D.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief 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 (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.
2. 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.
3. 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:

1. For the primary outcome, the investigators hypothesize that those who receive the intervention will have reduced transmission-risk behavior.
2. 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.

### Conditions Module

**Conditions:**

- Sexual Risk Behavior

- Childhood Sexual Abuse

- Stress Disorders, Post-Traumatic

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 232

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Cognitive Processing Therapy for Sexual Risk

- Behavioral: Sexual Risk Reduction Intervention

**Label:** Cognitive Processing Therapy for Sexual Risk (CPT-SR)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The TMC will be comprised of sexual risk reduction counseling/education and supportive psychotherapy.

**Intervention Names:**

- Behavioral: Supportive Psychotherapy

- Behavioral: Sexual Risk Reduction Intervention

**Label:** Time-Matched Control (TMC)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cognitive Processing Therapy for Sexual Risk (CPT-SR)

**Description:** Eight weekly sessions, 4 modules.

**Name:** Cognitive Processing Therapy for Sexual Risk

**Other Names:**

- CPT-SR

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Time-Matched Control (TMC)

**Description:** Eight weekly sessions

**Name:** Supportive Psychotherapy

**Other Names:**

- TMC

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Cognitive Processing Therapy for Sexual Risk (CPT-SR)

- Time-Matched Control (TMC)

**Description:** Two weekly sessions.

**Name:** Sexual Risk Reduction Intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

#### Secondary Outcomes

**Description:** 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.

**Measure:** Changes from Baseline in Trauma Symptom Severity

**Time Frame:** Baseline assessment, 3, 6, and 9-month follow-up assessments

### Eligibility Module

**Eligibility Criteria:** Eligibility Criteria:

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Coral Gables

**Country:** United States

**Facility:** University of Miami

**State:** Florida

**Zip:** 33124-0751

**Location 2:**

**City:** Boston

**Country:** United States

**Facility:** Massachusetts General Hospital

**State:** Massachusetts

**Zip:** 02114-2919

**Location 3:**

**City:** Boston

**Country:** United States

**Facility:** The Fenway Institute

**State:** Massachusetts

**Zip:** 02215

#### Overall Officials

**Official 1:**

**Affiliation:** Massachusetts General Hospital

**Name:** Conall O'Cleirigh, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 34676467

**Citation:** Batchelder 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.

**PMID:** 30973745

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Stress Disorders, Post-Traumatic

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

### Misc Info Module

- Version Holder: 2024-05-24
