Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
- Conditions
- HIVAdolescent BehaviorGender
- Interventions
- Other: Male-Specific Intervention PackageOther: Female-Specific Intervention PackageDrug: Pre-Exposure Prophylaxis (Females)Behavioral: Cash Transfer Cohort (Females)
- Registration Number
- NCT01571128
- Lead Sponsor
- New York University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1215
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Male-Specific Intervention Package Male-Specific Intervention Package Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm. Female-Specific Intervention Package Female-Specific Intervention Package Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm. Pre-Exposure Prophylaxis (Females) Pre-Exposure Prophylaxis (Females) PrEP adherence and feasibility. Longitudinal Arm. Cash Transfer Cohort (Females) Cash Transfer Cohort (Females) School attendance, behavioral data, and feasibility. Longitudinal Arm
- Primary Outcome Measures
Name Time Method Intervention Uptake (acceptability) and Coverage (feasibility) 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 Outcome Measures
Name Time Method Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months 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.
Trial Locations
- Locations (3)
New York University
πΊπΈNew York, New York, United States
Impact Research and Development Organization
π°πͺKisumu, Kenya
University of Nairobi
π°πͺNairobi, Kenya