Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection (HPTN062)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HIV Prevention Trials Network
ClinicalTrials.gov Identifier:
NCT01197027
First received: September 7, 2010
Last updated: June 4, 2012
Last verified: June 2012

September 7, 2010
June 4, 2012
February 2010
March 2012   (final data collection date for primary outcome measure)
Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01197027 on ClinicalTrials.gov Archive Site
Number of self-reported unprotected sex acts [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection
Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection

The purpose of this study is to evaluate the acceptability and feasibility of an enhanced, individual-level counseling intervention for individuals in the acute and early phase of HIV infection aimed at reducing risk behaviors.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Acute HIV Infection
Behavioral: Standard counseling
Standard HIV counseling
  • Experimental: Enhanced counseling
    5 intensive counseling sessions following acute HIV infection
    Intervention: Behavioral: Standard counseling
  • Active Comparator: Standard counseling
    Standard HIV counseling following acute HIV infection
    Intervention: Behavioral: Standard counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be enrolled in CHAVI 001 Note: The inclusion and exclusion criteria for CHAVI 001 are provided below. The criteria will not be reassessed prior to enrollment in HPTN 062.
  • Inclusion Criteria from CHAVI 001

    • Men and women aged ≥ 18 years at the time of screening.
    • Able and willing to provide adequate information for locator purposes.
    • Hemoglobin > 10.0 g/dL.
    • Willing to receive HIV test results.
    • Not intending to relocate out of the area for the duration of study participation and does not have a job or other obligations that may require long absences from the area.
    • Has acute HIV infection. (See Section 2.3 for definition).

Exclusion Criteria:

  • Any prior or current use of antiretroviral therapy (ART). This does not apply to individuals screening for Group 1A. ART use for the prevention of perinatal transmission may be waived after prior consultation with the protocol team.

    • Previous or current participation in a HIV vaccine study. HPTN 062 Version 3.0 Final 03 August 2010
    • Any condition that, in the opinion of the Investigator of Record, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT01197027
HPTN062
No
HIV Prevention Trials Network
HIV Prevention Trials Network
Not Provided
Study Chair: Amy Corneli, PhD FHI 360
Study Chair: Audrey Pettifor, PhD FHI 360
Principal Investigator: Francis Martinson, Md, PhD Kamuzu Central Hospital
HIV Prevention Trials Network
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP