Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth) (MP3-Youth)
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|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|
|Actual Primary Completion Date :||March 23, 2016|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|