- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03307226
Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Masaka, Uganda, 256
- International Center for Child Health and Development
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Masaka, Uganda
- International Center for Child Health and Development
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
(1) female; (2) enrolled in first year of secondary school in Rakai, Masaka, Lwengo or Kalungu districts; (3) age 14-17 years; (4) living within a family (broadly defined and not an institution or orphanage, as those in institutions have different familial needs)
Exclusion Criteria:
(5) they have a cognitive or severe psychiatric impairment that would prevent comprehension of study procedures as assessed during the Informed Consent process or; (6) they are unwilling or unable to commit to completing the study.
We will not exclude girls because of their HIV, STI and/or pregnancy status. Analysis will be adjusted to account for these baseline factors. Girls testing positive for HIV, STI or pregnancy will be referred for care and support.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Youth Development Accounts (YDA)
Youth Development Accounts (YDA)
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Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
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Eksperimentel: YDA + Multiple Family Groups (MFG)
YDA + Multiple Family Groups (MFG)
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Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
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Ingen indgriben: Usual Care
Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in proportion of STIs from baseline to follow-up assessments
Tidsramme: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Change in proportion of girls biologically confirmed STIs (Gonorrhea, Tirchomonas, and Chlamydia) at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in proportion of new HIV infections
Tidsramme: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Change in the proportion of new HIV infections at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Change in adherence to HIV treatment from baseline to follow-up assessments
Tidsramme: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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For HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts
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Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
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Cost-Effectiveness Analyses
Tidsramme: Every year for five years
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Cost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as an additional year of schooling, employment, or a reduction in a disease.
Costs will be measured on a per person basis.
The costs of the intervention will include all program costs.
Research costs will not be included.
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Every year for five years
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Fred Ssewamala, PhD, Washington University School of Medicine
Publikationer og nyttige links
Generelle publikationer
- Byansi W, Ssewamala FM, Neilands TB, Sensoy Bahar O, Nabunya P, Namuwonge F, McKay MM. The Short-Term Impact of a Combination Intervention on Depressive Symptoms Among School-Going Adolescent Girls in Southwestern Uganda: The Suubi4Her Cluster Randomized Trial. J Adolesc Health. 2022 Sep;71(3):301-307. doi: 10.1016/j.jadohealth.2022.04.008. Epub 2022 Jun 1.
- Nabunya P, Damulira C, Byansi W, Muwanga J, Bahar OS, Namuwonge F, Ighofose E, Brathwaite R, Tumwesige W, Ssewamala FM. Prevalence and correlates of depressive symptoms among high school adolescent girls in southern Uganda. BMC Public Health. 2020 Nov 25;20(1):1792. doi: 10.1186/s12889-020-09937-2.
- Ssewamala FM, Bermudez LG, Neilands TB, Mellins CA, McKay MM, Garfinkel I, Sensoy Bahar O, Nakigozi G, Mukasa M, Stark L, Damulira C, Nattabi J, Kivumbi A. Suubi4Her: a study protocol to examine the impact and cost associated with a combination intervention to prevent HIV risk behavior and improve mental health functioning among adolescent girls in Uganda. BMC Public Health. 2018 Jun 5;18(1):693. doi: 10.1186/s12889-018-5604-5.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- Langsomme virussygdomme
- HIV-infektioner
- Erhvervet immundefektsyndrom
Andre undersøgelses-id-numre
- 201703102
- 1R01MH113486-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Erasmus Medical CenterIkke rekrutterer endnuHIV-infektioner | Hiv | HIV-1-infektion | HIV I infektionHolland
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University of WashingtonNational Institute of Mental Health (NIMH)RekrutteringHIV-forebyggelse | HIV præeksponeringsprofylakse | ImplementeringKenya
Kliniske forsøg med Youth Development Accounts (YDA)
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Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...Ikke rekrutterer endnu
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University Hospital, Basel, SwitzerlandSwiss National Science FoundationRekrutteringAdfærdsforstyrrelse | Autisme-spektrum forstyrrelseSchweiz