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

• 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.
  
  

• 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
  
  

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.