NCT01571128

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,215 (actual)
• Sponsor: New York University · Academic / Other
• Sex: All
• Age: 15 Years – 24 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV
• Adolescent Behavior
• Gender

Interventions

Type	Name	Description
OTHER	Male-Specific Intervention Package	Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
OTHER	Female-Specific Intervention Package	Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
DRUG	Pre-Exposure Prophylaxis (Females)	Females 18-24 who are out of school.
BEHAVIORAL	Cash Transfer Cohort (Females)	Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-03-23
• Completion: 2016-03-23
• First posted: 2012-04-05
• Last updated: 2022-02-18

Locations

3 sites across 2 countries: United States, Kenya