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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by New York University
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: August 14, 2014
Last verified: August 2014

February 8, 2012
August 14, 2014
October 2014
May 2015   (final data collection date for primary outcome measure)
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
Number of male/female youth 15-24 years old (n = 200; subcohort) who uptake prevention intervention components who will be followed over 12-months to determine changes in behavior at three points in time (0, 6, and 12 months). [ Time Frame: 0, 6, and 12 months ] [ Designated as safety issue: No ]
Behavioral 1) risk factors and 2) longitidinal adherence to HIV prevention interventions will be measured by 1) self report via a cross-sectional ACASI interview and 2) a repeated text message survey for a subcohort of n=200 youth followed at 6- and 12-months who will be selected from the n=1000 youth enrolled in one-time mobile clinics.
Complete list of historical versions of study NCT01571128 on ClinicalTrials.gov Archive Site
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.
Prevention package operational outcomes [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
Feasibility and acceptability measures regarding the combination prevention packages will be collected, such as: cost effectiveness, cultural feasibility, cultural acceptability of package and location, scale up feasibility (cost, human resources, and sustainability), and fidelity
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.
Not Provided
 
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • Adolescent Behavior
  • Gender
  • 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)
  • 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)
  • Drug: Pre-Exposure Prophylaxis (Females)
    Females 18-24 who are out of school.
    Other Names:
    • Truvada
    • Emtricitabine
    • Tenofovir disoproxil fumarate
  • 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
  • Experimental: Male-Specific Intervention Package
    Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm.
    Intervention: Other: Male-Specific Intervention Package
  • Experimental: Female-Specific Intervention Package
    Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm.
    Intervention: Other: Female-Specific Intervention Package
  • 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.
    Intervention: Drug: Pre-Exposure Prophylaxis (Females)
  • Experimental: Cash Transfer Cohort (Females)
    School attendance, behavioral data, and feasibility. Longitudinal Arm
    Intervention: Behavioral: Cash Transfer Cohort (Females)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1320
May 2016
May 2015   (final data collection date for primary outcome measure)

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.
Both
15 Years to 24 Years
Yes
Contact: Ann Kurth, PhD 212-998-5316 akurth@nyu.edu
Contact: Jasmine Buttolph, MPH 212-992-7121 jb3436@nyu.edu
Kenya,   United States
 
NCT01571128
1R01AI094607-1
No
Ann Kurth, New York University
New York University
  • University of Nairobi
  • Impact Research and Development Organization (IRDO)
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
New York University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP