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

HIV Clinical Trial

— MP3-Youth  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571128
• Other study ID #: 1R01AI094607-1
• Secondary ID: 1R01AI094607
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 23, 2016

Study information

• Verified date: September 2018
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1215
• Est. completion date: March 23, 2016
• Est. primary completion date: March 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Gender
• HIV

Intervention

Other:
• Male-Specific Intervention Package
Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
• Female-Specific Intervention Package
Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.

Drug:
• Pre-Exposure Prophylaxis (Females)
Females 18-24 who are out of school.

Behavioral:
• Cash Transfer Cohort (Females)
Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.

Locations

Country	Name	City	State
Kenya	Impact Research and Development Organization	Kisumu
Kenya	University of Nairobi	Nairobi
United States	New York University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University	Impact Research & Development Organization, University of Nairobi

Countries where clinical trial is conducted

United States,  Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of administering cash transfer to keep girls in school	Conditional Cash Transfer to reduce HIV risk by staying in school.	12 months
Primary	Intervention Uptake (acceptability) and Coverage (feasibility)	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	6 months
Secondary	Adherence to medication (HIV+ and PrEP cohort participants only) over 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.	12 months