Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
MP3-Youth
2 other identifiers
interventional
1,215
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Nov 2014
Shorter than P25 for not_applicable hiv
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2016
CompletedFebruary 18, 2022
September 1, 2018
1.4 years
February 8, 2012
February 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intervention Uptake (acceptability) and Coverage (feasibility)
* Coverage: The proportion of youth in the community who attend each mobile event (estimated from youth population denominator) * Enrollment: The number of participants who consent to being enrolled in the study during each mobile event. * Uptake: The number of participants who choose one or more components of their tailored combination package (and which components). * Intervention Acceptability: Satisfaction with mobile event services
6 months
Secondary Outcomes (1)
Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months
12 months
Other Outcomes (1)
Feasibility of administering cash transfer to keep girls in school
12 months
Study Arms (5)
Male-Specific Intervention Package
EXPERIMENTALGender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm.
Female-Specific Intervention Package
EXPERIMENTALGender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm.
HIV Positive Cohort (Males and Females)
NO INTERVENTIONBehavioral data on HIV positive youth. Longitudinal Arm.
Pre-Exposure Prophylaxis (Females)
EXPERIMENTALPrEP adherence and feasibility. Longitudinal Arm.
Cash Transfer Cohort (Females)
EXPERIMENTALSchool attendance, behavioral data, and feasibility. Longitudinal Arm
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York Universitylead
- University of Nairobicollaborator
- Impact Research & Development Organizationcollaborator
Study Sites (3)
New York University
New York, New York, 10003, United States
Impact Research and Development Organization
Kisumu, Kenya
University of Nairobi
Nairobi, Kenya
Related Publications (1)
Buttolph J, Inwani I, Agot K, Cleland CM, Cherutich P, Kiarie JN, Osoti A, Celum CL, Baeten JM, Nduati R, Kinuthia J, Hallett TB, Alsallaq R, Kurth AE. Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol. JMIR Res Protoc. 2017 Mar 8;6(3):e22. doi: 10.2196/resprot.5833.
PMID: 28274904DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irene Inwani, MD, MPH
Kenyatta National Hospital: University of Nairobi, Kenya
- PRINCIPAL INVESTIGATOR
Ann Kurth, PhD, CNM
New York University
- STUDY DIRECTOR
Jasmine Buttolph, MPH
New York University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2012
First Posted
April 5, 2012
Study Start
November 1, 2014
Primary Completion
March 23, 2016
Study Completion
March 23, 2016
Last Updated
February 18, 2022
Record last verified: 2018-09