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Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection (HPTN062)
This study has been completed.
Sponsor:
HIV Prevention Trials Network
Information provided by (Responsible Party):
HIV Prevention Trials Network
ClinicalTrials.gov Identifier:
NCT01197027
First received: September 7, 2010
Last updated: June 4, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Acute HIV Infection | Behavioral: Standard counseling | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection |
Resource links provided by NLM:
Further study details as provided by HIV Prevention Trials Network:
Primary Outcome Measures:
- 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 Measures:
- Number of self-reported unprotected sex acts [ Time Frame: 6 months ]
| Enrollment: | 28 |
| Study Start Date: | February 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Enhanced counseling
5 intensive counseling sessions following acute HIV infection
|
Behavioral: Standard counseling
Standard HIV counseling
|
|
Active Comparator: Standard counseling
Standard HIV counseling following acute HIV infection
|
Behavioral: Standard counseling
Standard HIV counseling
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197027
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197027
Locations
| Malawi | |
| Kamuzu Central Hospital | |
| Lilongwe, Malawi | |
Sponsors and Collaborators
HIV Prevention Trials Network
Investigators
| Study Chair: | Amy Corneli, PhD | FHI 360 |
| Study Chair: | Audrey Pettifor, PhD | FHI 360 |
| Principal Investigator: | Francis Martinson, Md, PhD | Kamuzu Central Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | HIV Prevention Trials Network |
| ClinicalTrials.gov Identifier: | NCT01197027 History of Changes |
| Other Study ID Numbers: |
HPTN062 |
| Study First Received: | September 7, 2010 |
| Last Updated: | June 4, 2012 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Infection Communicable Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on September 19, 2017