Intervention to Improve Engagement in Care Among Newly Diagnosed HIV-positive Men

This study is currently recruiting participants.
Verified February 2013 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patrick Wilson, Columbia University
ClinicalTrials.gov Identifier:
NCT01559805
First received: March 16, 2012
Last updated: February 17, 2013
Last verified: February 2013
  Purpose

The study involves delivering one of two interventions - either Promoting Action Towards Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men (MSM) who have recently been diagnosed with HIV and assessing whether participants who received PATH achieve greater suppression of HIV viral load, demonstrate greater uptake of care and adherence to treatment, and engage in less sexual HIV transmission risk behavior than participants who received PCC.

  • PATH consists of two preliminary sessions plus "booster" sessions after 1, 3, and 6 months.
  • Personalized Cognitive Counseling consists of one session.

Participants will complete assessments before participating in their intervention (i.e., at "baseline") and at 3, 6, 9, and 12 month follow-up points. Participants' viral loads will be measured at approximately 6 and 12 months following baseline.


Condition Intervention
HIV
Patient Compliance
Behavioral: Positive Choices
Behavioral: Personalized Cognitive Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Trial of a Brief Health Enhancement Intervention for Newly Diagnosed Men

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Viral load [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual HIV transmission risk behavior [ Time Frame: Baseline, post (3 months), 6, 9, and 12 months ] [ Designated as safety issue: No ]
    Timeline Followback Method (Sobell et al., 1996) for Transmission Risk Behavior, Risk Reduction Behavioral Intentions (Fisher, 1992), HIV Serostatus Disclosure (Kalichman, 2001) & HIV Disclosure or Nondisclosure (Serovich & Mosack, 2003), Risk Reduction Self-Efficacy (Kalichman, 2001), Risk Reduction Skill Enactment (Kalichman, 2001), Compulsive Sexual Behavior Inventory (Minor et al., 2007), Sexual Sensation Seeking (Kalichman & Rompa, 1995)

  • Care and treatment uptake/adherence [ Time Frame: Baseline, post (3 months), 6, 9, and 12 months ] [ Designated as safety issue: No ]
    • Medical Chart/Self-report to assess Treatment Utilization
    • HIV Treatment and Risk-Related Knowledge (Kalichman, 2000)

  • Viral load [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: November 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positive Choices
A two-session, individually-focused intervention focusing on engagement in care, disclosure decision-making, and sexual risk reduction, with booster sessions after 1, 3 and 6 months.
Behavioral: Positive Choices
A two-session, individually-focused intervention focusing on engagement in care, disclosure decision-making, and sexual risk reduction, with booster sessions after 1, 3 and 6 months.
Active Comparator: Personalized Cognitive Counseling
A one-session, individually-focused risk reduction intervention for MSM that has been selected by the CDC as a DEBI.
Behavioral: Personalized Cognitive Counseling
A one-session, individually-focused risk reduction intervention for MSM that has been selected by the CDC as a DEBI.

Detailed Description:

Objectives:

The investigators will conduct a randomized controlled trial to test the efficacy of Promoting Action Towards Health (PATH), a brief health-enhancement and risk reduction intervention targeting newly HIV diagnosed men who have sex with men (MSM).

Specific Aims:

The investigators will establish the efficacy of PATH. The following hypotheses will be tested: Participants in the experimental condition will (1) achieve significantly greater suppression of HIV viral load; (2) demonstrate greater uptake of care and adherence to treatment; and (3) engage in less sexual HIV transmission risk behavior across the study duration than participants in the comparison condition.

Procedures:

440 newly HIV diagnosed (within three months) men will be randomly assigned to either: (1) the PATH experimental condition, or (2) the PCC comparison condition and followed for one year. HIV counselors will be trained to deliver the interventions within each condition. Assessments will be conducted at baseline, 3, 6, 9 and 12 months.

Significance:

Given increases in HIV incidence among MSM, advances in HIV treatment, and the demonstrated efficacy of early treatment in preventing HIV transmission, there is a critical need for effective interventions that can increase engagement and retention of MSM in care and reduce sexual HIV transmission risk behavior. PATH can be seamlessly integrated into medical care and translated into a sustainable model of care for newly diagnosed MSM to meet the urgent need for care programs that identify, treat, and prevent HIV infections.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • receiving an HIV diagnosis within the previous two months
  • entry into HIV primary care
  • residence in the greater New York metropolitan area
  • aged 18 or older
  • provision of written informed consent

Exclusion Criteria:

-demonstrating cognitive impairment, acute psychosis, or suicidal intent or plans

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559805

Contacts
Contact: Jill Pace, MPH 212-342-4144 jp3299@columbia.edu

Locations
United States, Connecticut
Yale University Active, not recruiting
New Haven, Connecticut, United States, 06511
United States, New York
Mailman School of Public Health, Columbia University Recruiting
New York, New York, United States, 10032
Contact: Arlene Kochman, LCSW    212-271-7203    info@pathstudy.net   
Principal Investigator: Patrick A Wilson, PhD         
Callen-Lorde Community Health Center Recruiting
New York, New York, United States, 10011
Contact: Arlene Kochman, LCSW    212-271-7203    info@pathstudy.net   
Principal Investigator: Anita E Radix, MD         
Harlem United Community AIDS Center, Inc. Recruiting
New York, New York, United States, 10027
Contact: Arlene Kochman, LCSW    212-271-7203    info@pathstudy.net   
Principal Investigator: Tamika Howell, PhD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Patrick A Wilson, PhD Columbia University
Principal Investigator: Nathan B Hansen, PhD Yale University
  More Information

Publications:
Responsible Party: Patrick Wilson, Associate Professor of Sociomedical Sciences, Columbia University
ClinicalTrials.gov Identifier: NCT01559805     History of Changes
Other Study ID Numbers: AAAJ3106, R01MH097651
Study First Received: March 16, 2012
Last Updated: February 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
HIV
Viral Load
Risk
Patient Compliance
Homosexuality, Male
Anti-Retroviral Agents

Additional relevant MeSH terms:
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014