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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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:


Acquired Immunodeficiency Syndrome HIV Infections Communicable Diseases Infection Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections	RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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