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

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.

Inclusion Criteria:

- Any male or female between the ages of 15-24.

- Able to understand spoken English or Kiswahili or Dholuo.

- Willing to give informed consent or if younger than 18 years of age has a parent or
guardian willing to provide consent in addition to the minor's assent

- Willing to be tested for HIV.

- Willing to get participant ID based on biometric finger scan.

Exclusion Criteria:

- Any male or female younger than 15 or older than 24.

- Unable to understand spoken English, or Kiswahili or Dholuo.

- If under 18 and not an emancipated minor, unable to get parental consent.