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NCT01197027 Clinical Trial

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

Acute HIV Infection Clinical Trial

Official title:
Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01197027
Other study ID # HPTN 062
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2010
Est. completion date April 2012

Study information
Verified date August 2022
Source HIV Prevention Trials Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date April 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Standard counseling
Standard HIV counseling

Locations
Country Name City State
Malawi Kamuzu Central Hospital Lilongwe

Sponsors (1)
Lead Sponsor Collaborator
HIV Prevention Trials Network

Country where clinical trial is conducted

Malawi, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit Week 2
Secondary Number of self-reported unprotected sex acts 6 months
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