Clinical trial NCT01197027: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute HIV Infection
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
First posted: 2010-09-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit
timeFrame: Week 2
Secondary outcomes:
measure: Number of self-reported unprotected sex acts
timeFrame: 6 months
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Kamuzu Central Hospital
Study officials:
affiliation: FHI 360
name: Amy Corneli, PhD
role: STUDY_CHAIR
affiliation: FHI 360
name: Audrey Pettifor, PhD
role: STUDY_CHAIR
affiliation: Kamuzu Central Hospital
name: Francis Martinson, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.