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

January 5, 2022 updated by: Columbia University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 12 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.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • New York
      • New York, New York, United States, 10011
        • Callen-Lorde Community Health Center
      • New York, New York, United States, 10027
        • Harlem United Community AIDS Center, Inc.
      • New York, New York, United States, 10032
        • Mailman School of Public Health, Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • receiving an HIV diagnosis within the previous 12 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral load
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual HIV transmission risk behavior
Time Frame: Baseline, post (3 months), 6, 9, and 12 months
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)
Baseline, post (3 months), 6, 9, and 12 months
Care and treatment uptake/adherence
Time Frame: Baseline, post (3 months), 6, 9, and 12 months
  • Medical Chart/Self-report to assess Treatment Utilization
  • HIV Treatment and Risk-Related Knowledge (Kalichman, 2000)
Baseline, post (3 months), 6, 9, and 12 months
Viral load
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Patrick A Wilson, PhD, Columbia University
  • Principal Investigator: Nathan B Hansen, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 6, 2017

Study Completion (Actual)

December 14, 2021

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAAJ3106
  • R01MH097651 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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