Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02845284
Other study ID # IRB00061475
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2016
Est. completion date December 30, 2017

Study information

Verified date May 2019
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 486
Est. completion date December 30, 2017
Est. primary completion date December 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 19 Years
Eligibility 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)

Study Design


Intervention

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.
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.

Locations

Country Name City State
Uganda MUJHU CARE Ltd Kampala Wakiso DIstrict

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University MU-JHU CARE

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite measure of consistent condom-use and use of an effective family planning method method A log-binomial regression model will be used to obtain the prevalence rate ratios. A comparison of this binary outcome will be conducted at one year.
Primary Incidence of any Sexually Transmitted Infection Kaplan-Meier survival analysis will be conducted to determine differences in the probability of sexually transmitted infection between study arms. at one year
See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Completed NCT02528136 - The Clinical Carbetocin Myocardium Trial Phase 4