Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2012 by New York University
Sponsor:
Collaborator:
University of Nairobi
Information provided by (Responsible Party):
Ann Kurth, New York University
ClinicalTrials.gov Identifier:
NCT01571128
First received: February 8, 2012
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

The MP3-Youth study will provide critical information for design and evaluation of combination HIV prevention intervention packages that are sensitive to gender-specific risks among this most-at-risk population in high-HIV burden African settings.


Condition Intervention Phase
Adolescent HIV Prevention
Adolescent Unintended Pregnancy
Behavioral: combination HIV prevention package for boys and girls
Phase 4

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Gender-Specific Combination HIV Prevention for Youth in High Burden Settings

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • Number of male/female youth 15-24 years old (n = 200; subcohort) who uptake prevention intervention components who will be followed over 12-months to determine changes in behavior at three points in time (0, 6, and 12 months). [ Time Frame: 0, 6, and 12 months ] [ Designated as safety issue: No ]
    Behavioral 1) risk factors and 2) longitidinal adherence to HIV prevention interventions will be measured by 1) self report via a cross-sectional ACASI interview and 2) a repeated text message survey for a subcohort of n=200 youth followed at 6- and 12-months who will be selected from the n=1000 youth enrolled in one-time mobile clinics.


Secondary Outcome Measures:
  • Prevention package operational outcomes [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Feasibility and acceptability measures regarding the combination prevention packages will be collected, such as: cost effectiveness, cultural feasibility, cultural acceptability of package and location, scale up feasibility (cost, human resources, and sustainability), and fidelity


Estimated Enrollment: 1320
Study Start Date: July 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
boys - intervention
gender specific intervention targeted specifically for boys
Behavioral: combination HIV prevention package for boys and girls
combination HIV prevention package for boys and for girls
girls - intervention
gender specific intervention targeted specifically for girls
Behavioral: combination HIV prevention package for boys and girls
combination HIV prevention package for boys and for girls

Detailed Description:

The MP3-Youth study will provide critical information for design and evaluation of combination HIV prevention intervention packages that are sensitive to gender-specific risks among this most-at-risk population in high-HIV burden African settings. Our team of biobehavioral and clinical scientists, mathematical modelers, and trial design specialists will:

Aim 1: Identify gender (sex)-specific drivers of HIV acquisition risk, including pregnancy among females, for youth in sub-Saharan Africa, and interventions to best address those risks.

Aim 2: Conduct mathematical modeling to select optimal combination intervention package components and to assess potential population-level impact.

Aim 3: In partnership with a highly-productive nongovernmental organization (NGO) that is delivering PEPFAR-funded HIV prevention services, develop and pilot a combination HIV prevention package specific for female and for male youth - 'MP3-Youth' - in Nyanza Province, Kenya.

Aim 4: Design a phase IV study protocol for testing the effectiveness of a gender-specific youth HIV prevention package in sub-Saharan Africa. We will disseminate these research protocol recommendations, and study instruments including the mathematical modeling tool, as a combination prevention intervention research toolkit.

Design: Study activities comprise systematic review and meta-analysis of the HIV prevention literature for youth in sub-Saharan Africa; development of a mathematical modeling tool; and a community-based HIV combination prevention pilot that will take place in western Kenya. These activities will culminate in a testable combination HIV prevention trial protocol for youth, which is the main study deliverable.

Population: Aim 1: Focus groups will be held with male and female youth, parents, teachers, religious and community leaders. Aim 3: Pilot study will include male and female youths (ages 15-24) from Nyanza Province, Kenya.

Deliverables: Study deliverables include selection procedures for a population-specific combination HIV prevention package; measurement instruments, mobile prevention delivery protocols, mathematical modeling tools, and a testable study trial protocol. The entire MP3-Youth Package will be placed on a web site for open access.

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Male and female youth 15-24 years old

Criteria

Inclusion Criteria:

  • boys/girls between the ages of 15-24
  • living in Western Kenya
  • Able to give consent

Exclusion Criteria:

  • not a boy/girl between the ages of 15-24
  • not living in Western Kenya
  • not fluent in KiSwahili or English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT01571128

Contacts
Contact: Ann Kurth, PhD 212-998-5316 akurth@nyu.edu
Contact: Jasmine Buttolph, MPH 212-992-7121 jb3436@nyu.edu

Locations
United States, New York
New York University Not yet recruiting
New york City, New York, United States, 10003
Contact: Ann Kurth, Phd    212-998-5316    akurth@nyu.edu   
Contact: Jasmine Buttolph, MPH    212-992-7121    jb3436@nyu.edu   
Principal Investigator: Ann Kurth, PhD         
Kenya
Impact Research and Development Organization Not yet recruiting
Kisumu, Kenya
Contact: Kawango Agot, PhD    +254 729390100    mamagifto@yahoo.com   
Contact: Spala Ohaga    +254 729390100    sohaga@impact-rdo.org   
Sub-Investigator: Kawango Agot, PhD         
University of Nairobi Not yet recruiting
Nairobi, Kenya
Contact: Irene Inwani, PhD    254 - 722608483    malweyi@wananchi.com   
Contact: Francis Njiri    254 - 722608483    fnjiri@gmail.com   
Principal Investigator: Irene Inwani, Phd         
Sponsors and Collaborators
New York University
University of Nairobi
Investigators
Principal Investigator: Irene Inwani, PhD University of Nairobi
Principal Investigator: Ann Kurth, PhD New York University
  More Information

No publications provided

Responsible Party: Ann Kurth, Principal Investigator, New York University
ClinicalTrials.gov Identifier: NCT01571128     History of Changes
Other Study ID Numbers: 1R01AI094607-1
Study First Received: February 8, 2012
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board
Kenya: Ethical Review Committee

Keywords provided by New York University:
HIV prevention
Unintended pregnancy
combination prevention
gender specific interventions

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 10, 2014