Adolescent Behavior, Gender, HIV
Conditions
Keywords
HIV, Prevention & Control, Intervention Studies, Adolescent, Gender, Combination prevention, Pre-Exposure Prophylaxis, Cash Transfer, Medical Male Circumcision, HIV Testing, Mobile Health
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.
Interventions
OTHERMale-Specific Intervention Package
Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
OTHERFemale-Specific Intervention Package
Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
DRUGPre-Exposure Prophylaxis (Females)
Females 18-24 who are out of school.
BEHAVIORALCash Transfer Cohort (Females)
Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.
Sponsors
University of Nairobi
Impact Research & Development Organization
New York University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of administering cash transfer to keep girls in school | 12 months | Conditional Cash Transfer to reduce HIV risk by staying in school. |
Countries
Kenya, United States
Outcome results
None listed