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

Primary Purpose

Acute HIV Infection

Status
Completed
Phase
Phase 3
Locations
Malawi
Study Type
Interventional
Intervention
Standard counseling
Sponsored by
HIV Prevention Trials Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute HIV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kamuzu Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced counseling

Standard counseling

Arm Description

5 intensive counseling sessions following acute HIV infection

Standard HIV counseling following acute HIV infection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of self-reported unprotected sex acts

Full Information

First Posted
September 7, 2010
Last Updated
August 25, 2022
Sponsor
HIV Prevention Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT01197027
Brief Title
Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection
Official Title
Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HIV Prevention Trials Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute HIV Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced counseling
Arm Type
Experimental
Arm Description
5 intensive counseling sessions following acute HIV infection
Arm Title
Standard counseling
Arm Type
Active Comparator
Arm Description
Standard HIV counseling following acute HIV infection
Intervention Type
Behavioral
Intervention Name(s)
Standard counseling
Intervention Description
Standard HIV counseling
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Number of self-reported unprotected sex acts
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Corneli, PhD
Organizational Affiliation
FHI 360
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Audrey Pettifor, PhD
Organizational Affiliation
FHI 360
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francis Martinson, Md, PhD
Organizational Affiliation
Kamuzu Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamuzu Central Hospital
City
Lilongwe
Country
Malawi

12. IPD Sharing Statement

Citations:
PubMed Identifier
25962118
Citation
Pettifor A, Corneli A, Kamanga G, McKenna K, Rosenberg NE, Yu X, Ou SS, Massa C, Wiyo P, Lynn D, Tharaldson J, Golin C, Hoffman I; HPTN 062 Study Protocol Team. HPTN 062: A Pilot Randomized Controlled Trial Exploring the Effect of a Motivational-Interviewing Intervention on Sexual Behavior among Individuals with Acute HIV Infection in Lilongwe, Malawi. PLoS One. 2015 May 11;10(5):e0124452. doi: 10.1371/journal.pone.0124452. eCollection 2015.
Results Reference
derived

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

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