- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Wakiso DIstrict
-
Kampala, Wakiso DIstrict, Uganda
- MUJHU Care Ltd
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Routine Care
Group education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C&T and family planning C&T services on request.
|
|
|
Experimentell: 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.
|
|
Experimentell: Routine Care plus individual support
Routine Care plus enhanced individual support
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Composite measure of consistent condom-use and use of an effective family planning method method
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Florence Mirembe, MMED, PhD, MU-JHU Care Ltd
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunologiska bristsyndrom
- Immunsystemets sjukdomar
- Sjukdomsegenskaper
- Långsamma virussjukdomar
- HIV-infektioner
- Förvärvat immunbristsyndrom
- Sexuellt överförbara sjukdomar
Andra studie-ID-nummer
- IRB00061475
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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