Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth)
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| First Received Date ICMJE | February 8, 2012 | ||||||||
| Last Updated Date | April 2, 2012 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01571128 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Gender-Specific Combination HIV Prevention for Youth in High Burden Settings | ||||||||
| Official Title ICMJE | Gender-Specific Combination HIV Prevention for Youth in High Burden Settings | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Ecologic or Community Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Male and female youth 15-24 years old |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: combination HIV prevention package for boys and girls
combination HIV prevention package for boys and for girls |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 1320 | ||||||||
| Estimated Completion Date | March 2015 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years to 24 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Kenya | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01571128 | ||||||||
| Other Study ID Numbers ICMJE | 1R01AI094607-1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ann Kurth, New York University | ||||||||
| Study Sponsor ICMJE | New York University | ||||||||
| Collaborators ICMJE | University of Nairobi | ||||||||
| Investigators ICMJE |
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| Information Provided By | New York University | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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