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Completed

NCT Number: NCT01197027

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

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.

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Key information

Conditions

Acute HIV Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kamuzu Central Hospital

Lilongwe, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Counseling

Behavioral

Standard HIV counseling

Primary outcomes

  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 outcomes

  1. Number of self-reported unprotected sex acts

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

HIV Prevention Trials Network

Network

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2010
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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