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Completed

NCT Number: NCT01571128

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

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.

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Key information

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Impact Research and Development Organization, Kisumu, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Male-Specific Intervention Package

Other

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)

Female-Specific Intervention Package

Other

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)

Pre-Exposure Prophylaxis (Females)

Drug

Females 18-24 who are out of school.

Other names: Truvada, Emtricitabine, Tenofovir disoproxil fumarate

Cash Transfer Cohort (Females)

Behavioral

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

Other names: Behavioral Economics, Conditional Cash Transfer

Primary outcomes

  1. Intervention Uptake (acceptability) and Coverage (feasibility)

    Time frame: 6 months

    • 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 outcomes

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

    Time frame: 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.

Other outcomes

  1. Feasibility of administering cash transfer to keep girls in school

    Time frame: 12 months

    Conditional Cash Transfer to reduce HIV risk by staying in school.

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • Impact Research & Development Organization
  • University of Nairobi

Registry information

Acronym: MP3-Youth

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2012
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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