HPTN 062

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

What is HPTN 062?

Protocol Status: Closed

Study Summary

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.

Protocol Team Member: Kevin McKenna get info

Protocol Co-Chair: Amy Corneli get info

Protocol Co-Chair: Audrey Pettifor get info

DAIDS Medical Officer: David Burns get info

DAIDS Medical Officer: Wairimu Chege get info