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

New York University1,215 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,215

Conditions

HIV Adolescent Behavior Gender

Interventions

Male-Specific Intervention PackageOTHER

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

Female-Specific Intervention PackageOTHER

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

Pre-Exposure Prophylaxis (Females)DRUG

Females 18-24 who are out of school.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 24 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

New York University

New York, New York, United States

Impact Research and Development Organization

Kisumu, Kenya

University of Nairobi

Nairobi, Kenya

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months

* Adherence to once daily Truvada (PrEP) among HIV-uninfected eligible females and patterns of adherence and sexual HIV acquisition risk exposure (PrEP cohort participants only). Measured by self-report, eCAPs, and clinical assessments; monthly for first 6 months and every 3 months for the following 6 months and DBS for analysis of TFV/FTC: TFV-DP/FTC-TP at months 2 and 9. * Adherence to ART for positives (HIV+ cohort participants only). Measured by self-report monthly SMS: 0, 3, 6,9,12 months). POC CD4 and baseline viral load by dried blood spot will be measured at mobile event baseline and repeated at 12 months.

Time frame: 12 months

Data from ClinicalTrials.gov

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