Clinical trial NCT01559805: Intervention to Improve Engagement in Care Among Newly Diagnosed HIV-positive Men
Official title: Efficacy Trial of a Brief Health Enhancement Intervention for Newly Diagnosed Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Patient Compliance
Keywords: HIV
Viral Load
Risk
Patient Compliance
Homosexuality, Male
Anti-Retroviral Agents
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-03-21
Enrollment: 202
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral load
timeFrame: 12 months
Secondary outcomes:
measure: Sexual HIV transmission risk behavior
timeFrame: Baseline, post (3 months), 6, 9, and 12 months
measure: Care and treatment uptake/adherence
timeFrame: Baseline, post (3 months), 6, 9, and 12 months
measure: Viral load
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: New York
country: United States
facility: Callen-Lorde Community Health Center
state: New York
city: New York
country: United States
facility: Harlem United Community AIDS Center, Inc.
state: New York
city: New York
country: United States
facility: Mailman School of Public Health, Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Patrick A Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Nathan B Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/jcop.20463.