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

This study is not yet open for participant recruitment.
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

February 8, 2012
April 2, 2012
July 2012
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01571128 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings

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.

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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Male and female youth 15-24 years old

  • Adolescent HIV Prevention
  • Adolescent Unintended Pregnancy
Behavioral: combination HIV prevention package for boys and girls
combination HIV prevention package for boys and for girls
  • boys - intervention
    gender specific intervention targeted specifically for boys
    Intervention: Behavioral: combination HIV prevention package for boys and girls
  • girls - intervention
    gender specific intervention targeted specifically for girls
    Intervention: Behavioral: combination HIV prevention package for boys and girls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1320
March 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
15 Years to 24 Years
Yes
Contact: Ann Kurth, PhD 212-998-5316 akurth@nyu.edu
Contact: Jasmine Buttolph, MPH 212-992-7121 jb3436@nyu.edu
United States,   Kenya
 
NCT01571128
1R01AI094607-1
No
Ann Kurth, New York University
New York University
University of Nairobi
Principal Investigator: Irene Inwani, PhD University of Nairobi
Principal Investigator: Ann Kurth, PhD New York University
New York University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP