Overview

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)
Phase phase 4
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm.
male-specific intervention package HIV Counseling and Testing (HTC)
Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
(Experimental)
Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm.
female-specific intervention package HIV Counseling and Testing (HTC)
Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
(No Intervention)
Behavioral data on HIV positive youth. Longitudinal Arm.
(Experimental)
PrEP adherence and feasibility. Longitudinal Arm.
pre-exposure prophylaxis (females) Truvada
Females 18-24 who are out of school.
(Experimental)
School attendance, behavioral data, and feasibility. Longitudinal Arm
cash transfer cohort (females) Behavioral Economics
Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.

Primary Outcomes

Measure
Intervention Uptake (acceptability) and Coverage (feasibility)
time frame: 6 months

Secondary Outcomes

Measure
Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months
time frame: 12 months

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by New York University.