Intervention to Improve Engagement in Care Among Newly Diagnosed HIV-positive Men
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2012 |
| End Date: | March 2017 |
| Contact: | Jill Pace, MPH |
| Email: | jp3299@columbia.edu |
| Phone: | 212-342-4144 |
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.
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 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.
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.
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
We found this trial at
4
sites
New York, New York 10011
Principal Investigator: Anita E Radix, MD
Phone: 212-271-7203
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10027
Principal Investigator: Tamika Howell, PhD
Phone: 212-271-7203
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New York, New York 10032
Principal Investigator: Patrick A Wilson, PhD
Phone: 212-271-7203
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