NCT01571128

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

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,215

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable hiv

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
2.6 years until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2016

Completed
Last Updated

February 18, 2022

Status Verified

September 1, 2018

Enrollment Period

1.4 years

First QC Date

February 8, 2012

Last Update Submit

February 2, 2022

Conditions

Keywords

HIVPrevention & ControlIntervention StudiesAdolescentGenderCombination preventionPre-Exposure ProphylaxisCash TransferMedical Male CircumcisionHIV TestingMobile Health

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

EXPERIMENTAL

Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm.

Other: Male-Specific Intervention Package

Female-Specific Intervention Package

EXPERIMENTAL

Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm.

Other: Female-Specific Intervention Package

HIV Positive Cohort (Males and Females)

NO INTERVENTION

Behavioral data on HIV positive youth. Longitudinal Arm.

Pre-Exposure Prophylaxis (Females)

EXPERIMENTAL

PrEP adherence and feasibility. Longitudinal Arm.

Drug: Pre-Exposure Prophylaxis (Females)

Cash Transfer Cohort (Females)

EXPERIMENTAL

School attendance, behavioral data, and feasibility. Longitudinal Arm

Behavioral: Cash Transfer Cohort (Females)

Interventions

Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.

Also known as: HIV Counseling and Testing (HTC), Facilitated linkage to care for HIV+: ART/PMTCT, Condoms, Voluntary Medical Male Circumcision (VMMC)
Male-Specific Intervention Package

Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.

Also known as: HIV Counseling and Testing (HTC), Facilitated linkage to care for HIV+: ART/PMTCT, Contraception/Family Planning (FP), Pre-exposure Prophylaxis (PrEP), Conditional Cash Transfer (CCT)
Female-Specific Intervention Package

Females 18-24 who are out of school.

Also known as: Truvada, Emtricitabine, Tenofovir disoproxil fumarate
Pre-Exposure Prophylaxis (Females)

Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.

Also known as: Behavioral Economics, Conditional Cash Transfer
Cash Transfer Cohort (Females)

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (3)

New York University

New York, New York, 10003, United States

Location

Impact Research and Development Organization

Kisumu, Kenya

Location

University of Nairobi

Nairobi, Kenya

Location

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.

MeSH Terms

Conditions

Adolescent BehaviorCoitus

Interventions

CondomsContraceptionFamily Planning ServicesPre-Exposure ProphylaxisEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationEmtricitabineTenofovirEconomics, Behavioral

Condition Hierarchy (Ancestors)

BehaviorSexual Behavior

Intervention Hierarchy (Ancestors)

Contraceptive Devices, MaleContraceptive DevicesEquipment and SuppliesReproductive TechniquesTherapeuticsCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesReproductive Health ServicesPrimary PreventionPreventive Health ServicesPublic Health PracticePublic HealthEnvironment and Public HealthOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical PreparationsPsychologyBehavioral SciencesBehavioral Disciplines and ActivitiesEconomicsHealth Care Economics and Organizations

Study Officials

  • Irene Inwani, MD, MPH

    Kenyatta National Hospital: University of Nairobi, Kenya

    PRINCIPAL INVESTIGATOR
  • Ann Kurth, PhD, CNM

    New York University

    PRINCIPAL INVESTIGATOR
  • Jasmine Buttolph, MPH

    New York University

    STUDY DIRECTOR

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

Locations