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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Acute HIV Infection	Behavioral: Standard counseling	Phase 3

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	28 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	February 2010
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	April 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit [ Time Frame: Week 2 ]

Secondary Outcome Measures :

1. Number of self-reported unprotected sex acts [ Time Frame: 6 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pettifor A, Corneli A, Kamanga G, McKenna K, Rosenberg NE, Yu X, Ou SS, Massa C, Wiyo P, Lynn D, Tharaldson J, Golin C, Hoffman I; HPTN 062 Study Protocol Team. HPTN 062: A Pilot Randomized Controlled Trial Exploring the Effect of a Motivational-Interviewing Intervention on Sexual Behavior among Individuals with Acute HIV Infection in Lilongwe, Malawi. PLoS One. 2015 May 11;10(5):e0124452. doi: 10.1371/journal.pone.0124452. eCollection 2015.

Responsible Party:	HIV Prevention Trials Network
ClinicalTrials.gov Identifier:	NCT01197027 History of Changes
Other Study ID Numbers:	HPTN062
First Posted:	September 9, 2010
Last Update Posted:	June 6, 2012
Last Verified:	June 2012

Additional relevant MeSH terms:

HIV Infections; Acquired Immunodeficiency Syndrome; Infection; Communicable Diseases; 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