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Completed

NCT Number: NCT01559805

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Choices

Behavioral

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.

Personalized Cognitive Counseling

Behavioral

A one-session, individually-focused risk reduction intervention for MSM that has been selected by the CDC as a DEBI.

Primary outcomes

  1. Viral load

    Time frame: 12 months

Secondary outcomes

  1. 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)

  2. 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)
  3. Viral load

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Efficacy Trial of a Brief Health Enhancement Intervention for Newly Diagnosed Men

Important dates

Study start
2012
Primary completion
2017
Study completion
2021
First posted
Mar 21, 2012
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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