- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02845284
'HI-4-TU' Study: Health Improvement for Teen Ugandans Study
Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The overall goal of this research to test the acceptability and effectiveness of two enhanced adolescent friendly reproductive health prevention interventions versus current routine care. In each intervention group, 152 adolescent mothers will be randomized to either the enhanced group peer support education and counseling intervention or to the enhanced one-to-one (individual) peer support education and counseling group with a young, model, peer educator trained to deliver Reproductive Health Education and counseling messages, beginning during pregnancy (≥ 28 weeks) and followed up to 9 months postpartum or study end at or after 6 months (whichever comes first). The control group will consist of 215 adolescent mothers randomized to routine care as provided at Mulago hospital (or the designated health facility) where midwives deliver group sessions during antenatal and postpartum care visits as well as standard PMTCT services including routine opt-out HIV C&T and availability of partner C&T. Syphilis testing should also be routinely provided and treatment provided for infected pregnant mothers and their partners as per local standard of care.
The 3 groups will be enrolled with study visits at 3, 6 and 9 months post partum however the intervention groups (Arms 2 and 3) will have additional visits at 36 weeks Antepartum, delivery, 6 and 10 weeks postpartum, Quantitative baseline data will be collected on routine demographic characteristics, reproductive history, pregnancy intentions and sexual risk/perceptions and HIV/Sexually Transmitted Infection status.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Wakiso DIstrict
-
Kampala, Wakiso DIstrict, Uganda
- MUJHU Care Ltd
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Pregnant at ≥28 weeks of gestation
- Agreeing to provide written informed consent to be screened for and take part in the study
- Agreeing to provide adequate locator information with residence within 30 km
- Agreeing to a home visit
- Agreeing to come for follow up visits and to receive study follow up phone calls
Exclusion Criteria:
- Serious illness or social conditions that would prevent adherence to study requirements
- High risk pregnancy or fetal death in utero (with the exception of risk defined only by maternal age)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Routine Care
Group education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C&T and family planning C&T services on request.
|
|
Eksperimentell: Routine Care plus group support
Routine Care plus enhanced group support
|
Routine Care plus enhanced group support, and peer education beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.
|
Eksperimentell: Routine Care plus individual support
Routine Care plus enhanced individual support
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Routine Care plus individual peer education and support beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Composite measure of consistent condom-use and use of an effective family planning method method
Tidsramme: A comparison of this binary outcome will be conducted at one year.
|
A log-binomial regression model will be used to obtain the prevalence rate ratios.
|
A comparison of this binary outcome will be conducted at one year.
|
Incidence of any Sexually Transmitted Infection
Tidsramme: at one year
|
Kaplan-Meier survival analysis will be conducted to determine differences in the probability of sexually transmitted infection between study arms.
|
at one year
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Florence Mirembe, MMED, PhD, MU-JHU Care Ltd
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Sykdomsattributter
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
- Seksuelt overførbare sykdommer
Andre studie-ID-numre
- IRB00061475
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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