Clinical trial NCT01571128: Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
Official title: Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Adolescent Behavior
Gender
Keywords: HIV
Prevention & Control
Intervention Studies
Adolescent
Gender
Combination prevention
Pre-Exposure Prophylaxis
Cash Transfer
Medical Male Circumcision
HIV Testing
Mobile Health
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: University of Nairobi
name: Impact Research & Development Organization
First posted: 2012-04-05
Enrollment: 1215
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Uptake (acceptability) and Coverage (feasibility)
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months
timeFrame: 12 months
Other outcomes:
measure: Feasibility of administering cash transfer to keep girls in school
timeFrame: 12 months
Locations:
city: New York
country: United States
facility: New York University
state: New York
city: Kisumu
country: Kenya
facility: Impact Research and Development Organization
city: Nairobi
country: Kenya
facility: University of Nairobi
Study officials:
affiliation: Kenyatta National Hospital: University of Nairobi, Kenya
name: Irene Inwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Ann Kurth, PhD, CNM
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Jasmine Buttolph, MPH
role: STUDY_DIRECTOR
References:
citation: 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.