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'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
Sponsor:
Collaborator:
MU-JHU CARE
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Pregnancy Human Immunodeficiency Virus Sexually Transmitted Diseases Behavioral: enhanced group support Behavioral: enhanced individual support Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 519 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Carolyne A Akello, MBChB +256 414 541 044 cakello@mujhu.org

Locations
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Uganda
MUJHU CARE Ltd Recruiting
Kampala, Wakiso DIstrict, Uganda
Contact: Carolyne A Akello, MBChB, MSc    +256 414 541 044    cakello@mujhu.org   
Contact: Judith Mbanza    +256 414 541 044      
Principal Investigator: Florence Mirembe, MMED, PhD         
Sponsors and Collaborators
Johns Hopkins University
MU-JHU CARE
Investigators
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Principal Investigator: Florence Mirembe, MMED, PhD MU-JHU Care Ltd

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02845284     History of Changes
Other Study ID Numbers: IRB00061475
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
adolescent
reproductive health

Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Sexually Transmitted Diseases
Immune System Diseases
Virus Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Infection