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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559805
• Other study ID #: AAAJ3106
• Secondary ID: R01MH097651
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: December 14, 2021

Study information

• Verified date: January 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 14, 2021
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Patient Compliance

Intervention

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

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut
United States	Callen-Lorde Community Health Center	New York	New York
United States	Harlem United Community AIDS Center, Inc.	New York	New York
United States	Mailman School of Public Health, Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load		12 months
Secondary	Sexual HIV transmission risk behavior	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
Secondary	Care and treatment uptake/adherence	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
Secondary	Viral load		6 months