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

This study is currently recruiting participants. (see Contacts and Locations)
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

March 16, 2012
February 17, 2013
November 2012
November 2016   (final data collection date for primary outcome measure)
Viral load [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01559805 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intervention to Improve Engagement in Care Among Newly Diagnosed HIV-positive Men
Efficacy Trial of a Brief Health Enhancement Intervention for Newly Diagnosed Men

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Patient Compliance
  • 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.
  • Behavioral: Personalized Cognitive Counseling
    A one-session, individually-focused risk reduction intervention for MSM that has been selected by the CDC as a DEBI.
  • 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.
    Intervention: Behavioral: Positive Choices
  • 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.
    Intervention: Behavioral: Personalized Cognitive Counseling
Sikkema KJ, Hansen NB, Kochman A, Santos J, Watt MH, Wilson PA, Delorenzo A, Laudato J, Mayer G. THE DEVELOPMENT AND FEASIBILITY OF A BRIEF RISK REDUCTION INTERVENTION FOR NEWLY HIV-DIAGNOSED MEN WHO HAVE SEX WITH MEN. J Community Psychol. 2011 Aug 1;39(6):717-732.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
March 2017
November 2016   (final data collection date for primary outcome measure)

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

Male
18 Years and older
No
Contact: Jill Pace, MPH 212-342-4144 jp3299@columbia.edu
United States
 
NCT01559805
AAAJ3106, R01MH097651
Yes
Patrick Wilson, Columbia University
Columbia University
National Institute of Mental Health (NIMH)
Principal Investigator: Patrick A Wilson, PhD Columbia University
Principal Investigator: Nathan B Hansen, PhD Yale University
Columbia University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP