Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth) (MP3-Youth)
|ClinicalTrials.gov Identifier: NCT01571128|
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : March 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Adolescent Behavior Gender||Other: Male-Specific Intervention Package Other: Female-Specific Intervention Package Drug: Pre-Exposure Prophylaxis (Females) Behavioral: Cash Transfer Cohort (Females)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1215 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)|
|Actual Study Start Date :||November 2014|
|Primary Completion Date :||March 23, 2016|
|Study Completion Date :||March 23, 2016|
Experimental: Male-Specific Intervention Package
Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm.
Other: Male-Specific Intervention Package
Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
Experimental: Female-Specific Intervention Package
Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm.
Other: Female-Specific Intervention Package
Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
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.
Drug: Pre-Exposure Prophylaxis (Females)
Females 18-24 who are out of school.
Experimental: Cash Transfer Cohort (Females)
School attendance, behavioral data, and feasibility. Longitudinal Arm
Behavioral: Cash Transfer Cohort (Females)
Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571128
|United States, New York|
|New York University|
|New York, New York, United States, 10003|
|Impact Research and Development Organization|
|University of Nairobi|
|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|