'HI-4-TU' Study: Health Improvement for Teen Ugandans Study
Condition: Pregnancy; Human Immunodeficiency Virus; Sexually Transmitted Diseases
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Sexually Transmitted Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): enhanced group support; enhanced individual support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: adolescent; reproductive health