'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
1 other identifier
interventional
486
1 country
1
Brief Summary
This randomized clinical trial is an adolescent focused implementation science study directed at improved social support and prevention of both HIV/STI's and subsequent unplanned pregnancies. The study population is pregnant adolescents who are attending antenatal care in Kampala, Uganda The acceptability and effectiveness of two enhanced peer lead, reproductive health promotion interventions compared to routine health care will be studied. The study participants will be individually randomized to one of three arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2016
CompletedFirst Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2017
CompletedMay 17, 2019
May 1, 2019
1.7 years
July 20, 2016
May 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Composite measure of consistent condom-use and use of an effective family planning method method
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
Kaplan-Meier survival analysis will be conducted to determine differences in the probability of sexually transmitted infection between study arms.
at one year
Study Arms (3)
Routine Care
NO INTERVENTIONGroup education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C\&T and family planning C\&T services on request.
Routine Care plus group support
EXPERIMENTALRoutine Care plus enhanced group support
Routine Care plus individual support
EXPERIMENTALRoutine Care plus enhanced individual support
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- MU-JHU CAREcollaborator
Study Sites (1)
MUJHU CARE Ltd
Kampala, Wakiso DIstrict, Uganda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florence Mirembe, MMED, PhD
MU-JHU Care Ltd
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 27, 2016
Study Start
March 30, 2016
Primary Completion
December 1, 2017
Study Completion
December 30, 2017
Last Updated
May 17, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share