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

Phase 3

Completed

• Conditions: Acute HIV Infection
• Interventions: Behavioral: Standard counseling

• Registration Number: NCT01197027
• Lead Sponsor: HIV Prevention Trials Network

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced counseling	Standard counseling	5 intensive counseling sessions following acute HIV infection
Standard counseling	Standard counseling	Standard HIV counseling following acute HIV infection

Primary Outcome Measures

Name	Time	Method
Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit	Week 2

Secondary Outcome Measures

Name	Time	Method
Number of self-reported unprotected sex acts	6 months

Trial Locations

Locations (1)

Kamuzu Central Hospital; 🇲🇼 Lilongwe, Malawi