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
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Acute HIV Infection
• Communicable Diseases
• HIV Infections
• Infections

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