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

August 25, 2022 updated by: HIV Prevention Trials Network
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Lilongwe, Malawi
        • Kamuzu Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit
Time Frame: Week 2
Week 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of self-reported unprotected sex acts
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPTN 062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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