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

NCT ID: NCT02845284

Last Updated: 2019-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 486 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-30
• Study Completion Date: 2017-12-30

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.

Conditions

Pregnancy; Human Immunodeficiency Virus; Sexually Transmitted Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Routine Care

Group education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C\&T and family planning C\&T services on request.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Routine Care plus group support

Routine Care plus enhanced group support

Group Type: EXPERIMENTAL

enhanced group support

Intervention Type: 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.

Routine Care plus individual support

Routine Care plus enhanced individual support

Group Type: EXPERIMENTAL

enhanced individual support

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

MU-JHU CARE

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence Mirembe, MMED, PhD

Role: PRINCIPAL_INVESTIGATOR

MU-JHU Care Ltd

Locations

MUJHU CARE Ltd

Kampala, Wakiso DIstrict, Uganda

Countries

Uganda

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00061475

Identifier Type: -

Identifier Source: org_study_id