Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-29 @ 7:41 PM
Study NCT ID:
NCT01571128
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2012-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
Sponsor:
New York University
Organization:
Study Overview
Official Title:
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MP3-Youth
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01AI094607 | NIH | None | https://reporter.nih.gov/quic… | View |