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

NCT01197027 | Completed Phase 3

• 1 other identifier: HPTN 062
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute HIV Infection

Outcome Measures

Primary Outcomes (1)

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

  Week 2

Secondary Outcomes (1)

• Number of self-reported unprotected sex acts

  6 months

Study Arms (2)

Enhanced counseling

EXPERIMENTAL

5 intensive counseling sessions following acute HIV infection

Behavioral: Standard counseling

Standard counseling

ACTIVE COMPARATOR

Standard HIV counseling following acute HIV infection

Behavioral: Standard counseling

Interventions

Standard counseling BEHAVIORAL

Standard HIV counseling

Enhanced counseling; Standard counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• HIV Prevention Trials Network: lead

Study Sites (1)

Kamuzu Central Hospital

Lilongwe, Malawi

Location

Related Publications (1)

• 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.

  PMID: 25962118 DERIVED

Study Officials

• Amy Corneli, PhD

  FHI 360

  STUDY CHAIR

• Audrey Pettifor, PhD

  FHI 360

  STUDY CHAIR

• Francis Martinson, Md, PhD

  Kamuzu Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 9, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

MA (1)