'HI-4-TU' Study: Health Improvement for Teen Ugandans Study
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|ClinicalTrials.gov Identifier: NCT02845284|
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Human Immunodeficiency Virus Sexually Transmitted Diseases||Behavioral: enhanced group support Behavioral: enhanced individual support||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||519 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
No Intervention: Routine Care
Group education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C&T and family planning C&T services on request.
Experimental: Routine Care plus group support
Routine Care plus enhanced group support
Behavioral: 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.
Experimental: Routine Care plus individual support
Routine Care plus enhanced individual support
Behavioral: 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.
- Composite measure of consistent condom-use and use of an effective family planning method method [ Time Frame: 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.
- Incidence of any Sexually Transmitted Infection [ Time Frame: at one year ]Kaplan-Meier survival analysis will be conducted to determine differences in the probability of sexually transmitted infection between study arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845284
|Contact: Carolyne A Akello, MBChB||+256 414 541 firstname.lastname@example.org|
|MUJHU CARE Ltd||Recruiting|
|Kampala, Wakiso DIstrict, Uganda|
|Contact: Carolyne A Akello, MBChB, MSc +256 414 541 044 email@example.com|
|Contact: Judith Mbanza +256 414 541 044|
|Principal Investigator: Florence Mirembe, MMED, PhD|
|Principal Investigator:||Florence Mirembe, MMED, PhD||MU-JHU Care Ltd|