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Completed

NCT Number: NCT02845284

'HI-4-TU' Study: Health Improvement for Teen Ugandans Study

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.

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Key information

Conditions

Pregnancy Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases HIV Infections Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

15 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MUJHU CARE Ltd

Kampala, Wakiso DIstrict, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

enhanced group support

Behavioral

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.

enhanced individual support

Behavioral

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • MU-JHU CARE

Registry information

Official study title

Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2016
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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