Clinical trial NCT02845284: 'HI-4-TU' Study: Health Improvement for Teen Ugandans Study
Official title: Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Human Immunodeficiency Virus
Sexually Transmitted Diseases
Keywords: adolescent
reproductive health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: MU-JHU CARE
First posted: 2016-07-27
Enrollment: 486
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Composite measure of consistent condom-use and use of an effective family planning method method
timeFrame: A comparison of this binary outcome will be conducted at one year.
measure: Incidence of any Sexually Transmitted Infection
timeFrame: at one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: MUJHU CARE Ltd
state: Wakiso DIstrict
Study officials:
affiliation: MU-JHU Care Ltd
name: Florence Mirembe, MMED, PhD
role: PRINCIPAL_INVESTIGATOR
References: