NCT01559805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
Last Updated

January 10, 2022

Status Verified

January 1, 2022

Enrollment Period

5 years

First QC Date

March 16, 2012

Last Update Submit

January 5, 2022

Conditions

HIVPatient Compliance

Keywords

HIVViral LoadRiskPatient ComplianceHomosexuality, MaleAnti-Retroviral Agents

Outcome Measures

Primary Outcomes (1)

  • Viral load

    12 months

Secondary Outcomes (3)

  • Sexual HIV transmission risk behavior

    Baseline, post (3 months), 6, 9, and 12 months

  • Care and treatment uptake/adherence

    Baseline, post (3 months), 6, 9, and 12 months

  • Viral load

    6 months

Study Arms (2)

Positive Choices

EXPERIMENTAL

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

Personalized Cognitive Counseling

ACTIVE COMPARATOR

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

Behavioral: Personalized Cognitive Counseling

Interventions

Positive ChoicesBEHAVIORAL

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.

Positive Choices
Personalized Cognitive CounselingBEHAVIORAL

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

Personalized Cognitive Counseling

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • demonstrating cognitive impairment, acute psychosis, or suicidal intent or plans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Yale University

New Haven, Connecticut, 06511, United States

Location

Callen-Lorde Community Health Center

New York, New York, 10011, United States

Location

Harlem United Community AIDS Center, Inc.

New York, New York, 10027, United States

Location

Mailman School of Public Health, Columbia University

New York, New York, 10032, United States

Location

Related 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. doi: 10.1002/jcop.20463.

    PMID: 22228917BACKGROUND

MeSH Terms

Conditions

Patient ComplianceHomosexuality, Male

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHomosexualitySexualitySexual Behavior

Study Officials

  • Patrick A Wilson, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Nathan B Hansen, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 21, 2012

Study Start

November 1, 2012

Primary Completion

November 6, 2017

Study Completion

December 14, 2021

Last Updated

January 10, 2022

Record last verified: 2022-01

Locations

US(4)