Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
This trial is active, not recruiting.
|Conditions||hiv, adolescent behavior, gender|
|Treatments||male-specific intervention package, female-specific intervention package, pre-exposure prophylaxis (females), cash transfer cohort (females)|
|Sponsor||New York University|
|Collaborator||University of Nairobi|
|Start date||November 2014|
|End date||April 2016|
|Trial size||1215 participants|
|Trial identifier||NCT01571128, 1R01AI094607-1|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Intervention model||parallel assignment|
Intervention Uptake (acceptability) and Coverage (feasibility)
time frame: 6 months
Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months
time frame: 12 months
Male or female participants from 15 years up to 24 years old.
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.
|Official title||Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)|
|Principal investigator||Irene Inwani, MD, MPH|
|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.|
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