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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI094607 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Nairobi | OTHER |
| Impact Research & Development Organization | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male-Specific Intervention Package | Experimental | Gender-specific interventions targeted specifically for boys offered in an integrated services delivery modality. Cross-Sectional Arm. |
|
| Female-Specific Intervention Package | Experimental | Gender-specific interventions targeted specifically for girls offered in an integrated services delivery modality. Cross-Sectional Arm. |
|
| HIV Positive Cohort (Males and Females) | No Intervention | Behavioral data on HIV positive youth. Longitudinal Arm. | |
| Pre-Exposure Prophylaxis (Females) | Experimental | PrEP adherence and feasibility. Longitudinal Arm. |
|
| Cash Transfer Cohort (Females) | Experimental | School attendance, behavioral data, and feasibility. Longitudinal Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Male-Specific Intervention Package | Other | Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Uptake (acceptability) and Coverage (feasibility) |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to medication (HIV+ and PrEP cohort participants only) over 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of administering cash transfer to keep girls in school | Conditional Cash Transfer to reduce HIV risk by staying in school. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Inwani, MD, MPH | Kenyatta National Hospital: University of Nairobi, Kenya | Principal Investigator |
| Ann Kurth, PhD, CNM | New York University | Principal Investigator |
| Jasmine Buttolph, MPH | New York University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University | New York | New York | 10003 | United States | ||
| Impact Research and Development Organization |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28274904 | Derived | Buttolph J, Inwani I, Agot K, Cleland CM, Cherutich P, Kiarie JN, Osoti A, Celum CL, Baeten JM, Nduati R, Kinuthia J, Hallett TB, Alsallaq R, Kurth AE. Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol. JMIR Res Protoc. 2017 Mar 8;6(3):e22. doi: 10.2196/resprot.5833. |
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|
| Female-Specific Intervention Package | Other | Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts. |
|
|
| Pre-Exposure Prophylaxis (Females) | Drug | Females 18-24 who are out of school. |
|
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| Cash Transfer Cohort (Females) | Behavioral | Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school. |
|
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| 12 months |
| Kisumu |
| Kenya |
| University of Nairobi | Nairobi | Kenya |
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012725 | Sexual Behavior |
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| ID | Term |
|---|---|
| D017280 | Condoms |
| D003267 | Contraception |
| D005193 | Family Planning Services |
| D065129 | Pre-Exposure Prophylaxis |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| D060909 | Economics, Behavioral |
| ID | Term |
|---|---|
| D003275 | Contraceptive Devices, Male |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D034121 | Reproductive Health Services |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011584 | Psychology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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