title: Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.
abstract: BACKGROUND
  Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya.
  
  
  OBJECTIVE
  The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention.
  
  
  METHODS
  The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming.
  
  
  RESULTS
  The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake.
  
  
  CONCLUSIONS
  The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54).
authors.affiliation: New York University, College of Nursing Global, New York, NY, United States.
authors.forename: Jasmine
authors.identifier: http://orcid.org/0000-0002-5959-4793
authors.initials: J
authors.lastname: Buttolph
authors.affiliation: University of Nairobi, Kenyatta National Hospital, Nairobi, Kenya.
authors.forename: Irene
authors.identifier: http://orcid.org/0000-0002-4912-1028
authors.initials: I
authors.lastname: Inwani
authors.affiliation: Impact Research & Development Organization (IRDO), Kisumu, Kenya.
authors.forename: Kawango
authors.identifier: http://orcid.org/0000-0002-0475-6951
authors.initials: K
authors.lastname: Agot
authors.affiliation: New York University, College of Nursing Global, New York, NY, United States.
authors.forename: Charles M
authors.identifier: http://orcid.org/0000-0002-6931-9904
authors.initials: CM
authors.lastname: Cleland
authors.affiliation: Kenya Ministry of Health, National AIDS & STI Control Program (NASCOP), Nairobi, Kenya.
authors.forename: Peter
authors.identifier: http://orcid.org/0000-0002-0019-0372
authors.initials: P
authors.lastname: Cherutich
authors.affiliation: University of Nairobi, Kenyatta National Hospital, Nairobi, Kenya.
authors.forename: James N
authors.identifier: http://orcid.org/0000-0003-4180-7858
authors.initials: JN
authors.lastname: Kiarie
authors.affiliation: Department of Obstetrics and Gynecology, Kenyatta National Hospital, University of Nairobi, Nairobi, Kenya.
authors.forename: Alfred
authors.identifier: http://orcid.org/0000-0002-2049-3100
authors.initials: A
authors.lastname: Osoti
authors.affiliation: University of Washington, School of Public Health, Seattle, WA, United States.
authors.forename: Connie L
authors.identifier: http://orcid.org/0000-0002-8813-3419
authors.initials: CL
authors.lastname: Celum
authors.affiliation: University of Washington, School of Public Health, Seattle, WA, United States.
authors.forename: Jared M
authors.identifier: http://orcid.org/0000-0001-8242-8438
authors.initials: JM
authors.lastname: Baeten
authors.affiliation: University of Nairobi, Kenyatta National Hospital, Nairobi, Kenya.
authors.forename: Ruth
authors.identifier: http://orcid.org/0000-0002-7311-9892
authors.initials: R
authors.lastname: Nduati
authors.affiliation: University of Nairobi, Kenyatta National Hospital, Nairobi, Kenya.
authors.forename: John
authors.identifier: http://orcid.org/0000-0002-3273-846X
authors.initials: J
authors.lastname: Kinuthia
authors.affiliation: Imperial College London, Department of Infectious Disease Epidemiology, London, United Kingdom.
authors.forename: Timothy B
authors.identifier: http://orcid.org/0000-0002-9681-0424
authors.initials: TB
authors.lastname: Hallett
authors.affiliation: New York University, College of Nursing Global, New York, NY, United States.
authors.forename: Ramzi
authors.identifier: http://orcid.org/0000-0002-2496-9620
authors.initials: R
authors.lastname: Alsallaq
authors.affiliation: New York University, College of Nursing Global, New York, NY, and Yale School of Nursing, New Haven, CT, United States.
authors.forename: Ann E
authors.identifier: http://orcid.org/0000-0003-2300-6723
authors.initials: AE
authors.lastname: Kurth
keywords: HIV; Kenya; PrEP; VMMC; biometrics; cash transfer; combination prevention; family planning; mobile health; youth