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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Nairobi
Impact Research and Development Organization (IRDO)
Information provided by (Responsible Party):
Ann Kurth, New York University
ClinicalTrials.gov Identifier:
NCT01571128
First received: February 8, 2012
Last updated: December 24, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
HIV
Adolescent Behavior
Gender
Other: Male-Specific Intervention Package
Other: Female-Specific Intervention Package
Drug: Pre-Exposure Prophylaxis (Females)
Behavioral: Cash Transfer Cohort (Females)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • Intervention Uptake (acceptability) and Coverage (feasibility) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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


Secondary Outcome Measures:
  • Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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.


Other Outcome Measures:
  • Feasibility of administering cash transfer to keep girls in school [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Conditional Cash Transfer to reduce HIV risk by staying in school.


Enrollment: 1215
Study Start Date: November 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Male-Specific Intervention Package
Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm.
Other: Male-Specific Intervention Package
Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
Other Names:
  • HIV Counseling and Testing (HTC)
  • Facilitated linkage to care for HIV+: ART/PMTCT
  • Condoms
  • Voluntary Medical Male Circumcision (VMMC)
Experimental: Female-Specific Intervention Package
Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm.
Other: Female-Specific Intervention Package
Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
Other Names:
  • 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)
No Intervention: HIV Positive Cohort (Males and Females)
Behavioral data on HIV positive youth. Longitudinal Arm.
Experimental: Pre-Exposure Prophylaxis (Females)
PrEP adherence and feasibility. Longitudinal Arm.
Drug: Pre-Exposure Prophylaxis (Females)
Females 18-24 who are out of school.
Other Names:
  • Truvada
  • Emtricitabine
  • Tenofovir disoproxil fumarate
Experimental: Cash Transfer Cohort (Females)
School attendance, behavioral data, and feasibility. Longitudinal Arm
Behavioral: Cash Transfer Cohort (Females)
Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.
Other Names:
  • Behavioral Economics
  • Conditional Cash Transfer

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

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571128

Locations
United States, New York
New York University
New York, New York, United States, 10003
Kenya
Impact Research and Development Organization
Kisumu, Kenya
University of Nairobi
Nairobi, Kenya
Sponsors and Collaborators
New York University
University of Nairobi
Impact Research and Development Organization (IRDO)
Investigators
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
  More Information

Responsible Party: Ann Kurth, Principal Investigator, New York University
ClinicalTrials.gov Identifier: NCT01571128     History of Changes
Other Study ID Numbers: 1R01AI094607-1 
Study First Received: February 8, 2012
Last Updated: December 24, 2015
Health Authority: United States: Institutional Review Board - University Committee on Activities Involving Human Subjects (UCAIHS)
United States: Federal Government
Kenya: Kenyatta National Hospital/University of Nairobi - Ethics and Research Committee (KNH-ERC)
Kenya: Pharmacy and Poisons Board of Kenya (PPB)

Keywords provided by New York University:
HIV
Prevention & Control
Intervention Studies
Adolescent
Gender
Combination prevention
Pre-Exposure Prophylaxis
Cash Transfer
Medical Male Circumcision
HIV Testing
Mobile Health

Additional relevant MeSH terms:
Tenofovir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016