Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
Condition: HIV; Adolescent Behavior; Gender
Study type: Interventional

Summary: 
      MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a gender-specific
      combination HIV prevention package for youth (aged 15-24) in high burden settings. The study
      aims to pilot a combination package of gender-specific interventions in western Kenya in a
      mobile health delivery format using integrated services delivery.
    

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.
    

Intervention name(s): Male-Specific Intervention Package; Female-Specific Intervention Package; Pre-Exposure Prophylaxis (Females); Cash Transfer Cohort (Females)
Intervention type(s): Other; Other; Drug; Behavioral
Intervention description(s): Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.; Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.; Females 18-24 who are out of school.; Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.
Other intervention name(s): HIV Counseling and Testing (HTC); Facilitated linkage to care for HIV+: ART/PMTCT; Condoms; Voluntary Medical Male Circumcision (VMMC); HIV Counseling and Testing (HTC); Facilitated linkage to care for HIV+: ART/PMTCT; Contraception/Family Planning (FP); Pre-exposure Prophylaxis (PrEP); Conditional Cash Transfer (CCT); Truvada; Emtricitabine; Tenofovir disoproxil fumarate; Behavioral Economics; Conditional Cash Transfer
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Prevention & Control; Intervention Studies; Adolescent; Gender; Combination prevention; Pre-Exposure Prophylaxis; Cash Transfer; Medical Male Circumcision; HIV Testing; Mobile Health