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
  Purpose

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.


Condition Intervention Phase
Acute HIV Infection
Behavioral: Standard counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection

Resource links provided by NLM:


Further study details as provided by HIV Prevention Trials Network:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Number of self-reported unprotected sex acts [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced counseling
5 intensive counseling sessions following acute HIV infection
Behavioral: Standard counseling
Standard HIV counseling
Active Comparator: Standard counseling
Standard HIV counseling following acute HIV infection
Behavioral: Standard counseling
Standard HIV counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197027

Locations
Malawi
Kamuzu Central Hospital
Lilongwe, Malawi
Sponsors and Collaborators
HIV Prevention Trials Network
Investigators
Study Chair: Amy Corneli, PhD FHI 360
Study Chair: Audrey Pettifor, PhD FHI 360
Principal Investigator: Francis Martinson, Md, PhD Kamuzu Central Hospital
  More Information

No publications provided

Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT01197027     History of Changes
Other Study ID Numbers: HPTN062
Study First Received: September 7, 2010
Last Updated: June 4, 2012
Health Authority: Malawi: National Health Sciences Research Committee

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 27, 2014