HPTN 062

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

Study Summary
Study Documents - Study Details - Key Study Personnel - Study Sites Publications
 

What is HPTN 062?

HPTN 062 was a research study conducted in Lilongwe, Malawi 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.

Who participated in the study?

A total of 28 participants diagnosed with acute HIV infection (AHI) were randomized to receive either brief education alone, or the brief education plus the Motivational Interviewing (MI)-based intervention, called Uphungu Wanga.

What happened during the study?

Participants in Uphungu Wanga received four sessions delivered on the day of diagnosis, three days later and at weeks 1 and 2 with a booster session at week 8; participants were followed for 24 weeks from diagnosis. An interviewer administered quantitative questionnaire was conducted at baseline and at weeks 2, 4, 8, 12, 16, 20 and 24. Semi-structured qualitative interviews (SSI) were conducted at weeks 2, 8, 12, and 24.

Results:

The majority of participants in both arms reported rapid and sustained behavior change following diagnosis with acute HIV infection. Very few participants reported having sex without a condom after diagnosis. Participants reported a trend towards fewer sex partners and abstaining from sex during study follow-up. Participants in the MI-based arm provided concrete examples of risk reduction strategies in the SSIs while those in the brief education arm primarily described reducing risk behavior, suggesting that the MI-based group may have acquired more risk reduction skills.

Study Documents

HPTN 062 Version 3.0

HPTN 062 Version 2.0

Study Details

Protocol Status: Concluded
Study Purpose:

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 Design:

A single-site, two arm, randomized study

Study Population:

Men and women 18 years of age or older diagnosed with acute HIV infection and enrolled in the Center for HIV/AIDS Vaccine Immunology (CHAVI) 001.

Study Size:

A target group of 46 individuals with acute HIV infection.

Study Duration:

The study will be conducted over approximately 2.5 years. Participants will be enrolled for approximately 24 months. Participants will be followed weekly for the first 2 weeks and then monthly starting at week 4 for a total of 6 months from enrollment.

Treatment Regimen:

Participants will be randomized in a 1:1 ratio to one of two study arms as shown below:

Experimental Arm: Standard HIV post-test counseling at enrollment (baseline), and standard risk- reduction counseling at follow-up plus Four enhanced counseling sessions between enrollment and week 2 and a fifth booster session at week 8.

Control Arm: Standard HIV post-test counseling at enrollment (baseline) and standard risk- reduction counseling at follow-up.

Primary Objectives:

1. To evaluate the feasibility of delivering an enhanced individual-level counseling intervention to individuals in the acute and early phases of HIV infection.

2. To evaluate the acceptability of an enhanced, individual-level counseling intervention among individuals in the acute and early phases of HIV infection

Secondary Objectives:

1. To examine the effectiveness of an enhanced, individual-level counseling intervention aimed at individuals in the acute and early phases of HIV infection in reducing risk behaviors for HIV transmission.

2. To examine participant risk behaviors for HIV transmission and participant perceptions of infectiousness after the acute and early phases of HIV infection.

Key Study Personnel

David Burns, DAIDS Medical Officer
Wairimu Chege, DAIDS Medical Officer
Audrey Pettifor, Protocol Co-Chair

Study Sites List