Intervention to Improve Engagement in Care Among Newly Diagnosed HIV-positive Men
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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 |
- Viral load [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Jill Pace, MPH | 212-342-4144 | jp3299@columbia.edu |
| 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 | |
| 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 May 23, 2013