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Comprehensive Reproductive Support Program for Pregnancy Prevention (PREVENT Trial)

N/A
Waitlist Available
Research Sponsored by Dr. Karen Yeates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women 15-19 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess a program to help adolescent girls better access contraceptive services and reduce unplanned pregnancies in Tanzania. The program uses mobile messaging, interactive voice response and connects girls to mentors and discreet access points.

Who is the study for?
The PREVENT Project is for girls aged 15-19 living in Kilimanjaro, Tanzania who can read SMS texts in English or Swahili. They must have a mobile phone, be willing to participate for 12 months, and not be pregnant nor planning pregnancy within the year. Girls using long-term contraception or with cognitive delays are excluded.
What is being tested?
This study tests an educational program on reproductive health via text messages and voice services. It connects participants to local support and discreet contraceptive access points. The case group receives additional personal support and access to contraceptives through the program.
What are the potential side effects?
Since this trial involves education and personal support rather than medical treatment, there are no direct side effects from medications; however, unintended consequences may include privacy concerns or misinformation if not properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman between 15 and 19 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in unmet need for contraceptives at 12 months
Change in unmet need for contraceptives at 6 months
Secondary study objectives
Change in the number of pregnancies among women at 12 months
Change in the number of pregnancies among women at 6 months
Questionnaire to test knowledge regarding sexual and reproductive health
Other study objectives
Number of participants to use voice response and access counseling

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Control InterventionExperimental Treatment2 Interventions
1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH. 2. Personal Support from community peer mentor to access counselling services through SRH
Group II: Case InterventionExperimental Treatment3 Interventions
1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH. 2. Personal Support from community peer mentor to access counselling services through SRH 3. Access to Contraception and counselling and service provision will be provided by the mobile reproductive health team at contraceptive access points.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Education
2017
N/A
~4790

Find a Location

Who is running the clinical trial?

Dr. Karen YeatesLead Sponsor
1 Previous Clinical Trials
3,000 Total Patients Enrolled
Queen's UniversityLead Sponsor
371 Previous Clinical Trials
123,747 Total Patients Enrolled

Media Library

Education Clinical Trial Eligibility Overview. Trial Name: NCT03995043 — N/A
Reproductive Behavior Research Study Groups: Case Intervention, Control Intervention
Reproductive Behavior Clinical Trial 2023: Education Highlights & Side Effects. Trial Name: NCT03995043 — N/A
Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT03995043 — N/A
~132 spots leftby Aug 2025
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