Project for Reproductive Equity Through Volunteers and Entrepreneurship, Networks and Technology (PREVENT)

March 17, 2025 updated by: Dr. Karen Yeates

Project for Reproductive Equity Through Volunteers and Entrepreneurship, Networks and Technology: the PREVENT Project Protocol

The PREVENT Project is a multifaceted, adolescent friendly, culturally competent program aimed to address the issues surrounding unplanned pregnancies and lack of access and uptake of contraceptive services among adolescent girls. The intervention uses a mobile platform that provides educational SMS (Short Message Service) messaging, interactive voice response, and connects adolescent girls to community based AFSRH (Adolescent Friendly Sexual Reproductive Health) counselling services, as well as discreet contraceptive access points headed by female entrepreneurs. The program will be piloted for 12 months in various wards and villages in rural and urban Kilimanjaro, Tanzania.The acceptability and practicality of the intervention will be assessed using mixed methods. Questionnaires and focus groups will be conducted with the study participants, as well as the medical and non-medical volunteers at the start and end of the pilot. The study will be heavily supported by all-female non-medical social entrepreneurs and sexual reproductive health community mentors (volunteers), and, all-female medical reproductive health team. Recruitment will also take place in hair saloons (local hair braiding and styling establishments) and other female run business such as tailors and female clothing stores that have enlisted to become contraceptive access points in the study. There will be 2 intervention groups, control and case group. Both groups will receive educational SMS (text) messages on SRH (Sexual Reproductive Health) and access individually tailored educational resources through interactive voice response (IVR) services/system via PREVENT mobile platform. In addition to personal support to be able to contact with a SRH community peer mentor in the community for AFSRH counselling and support. The case group will then have access to contraception provided with detailed and discreet information on accessing PREVENT contraceptive access points in all communities included in the study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The PREVENT study seeks to impact knowledge, perceptions, and behavioural changes regarding SRH among adolescent girls. As a result, the data collected in the PREVENT study will be grouped into two main themes: SRH knowledge and attitudes, as well as family planning (pregnancy avoidance) and contraceptive services uptake and outcomes. All data collected during the study will be directly entered and stored into the secure PREVENT mobile platform and related secure storage functions within the platform.

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Queens University
        • Contact:
        • Contact:
          • Karen E Yeates, MD
        • Contact:
          • Zac Mtema, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women 15-19 years of age
  • Reside within the study area for the duration of the study
  • Have a personal mobile phone and be willing to provide the phone number to the researchers to receive the intervention messages
  • Report being SMS literate (ie. able to read text messages in English or Swahili)
  • Be able and willing to return for follow-up after 12 months
  • Be able and willing to give written informed consent for enrollment in the study

Exclusion Criteria:

  • Be pregnant or planning pregnancy within 12 months (assessed when obtaining consent using HCG (human chorionic gonadotropin) urine dipstick).
  • Participation in another study or intervention that may affect the outcome of this study
  • Already utilizing a long-term form of contraception such as intra-uterine device, or implantable or inject-able contraception
  • Having a non-medical condition detected through screening that hinders study participation such as developmental or cognitive delay

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Intervention
  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
Behavioral: Education
Receive educational SMS (text) messages about contraceptive use and family planning on SRH and access individually tailored educational resources through interactive voice response (IVR) services/system via PREVENT mobile platform.
Behavioral: Personal Support
Contact with a female business owner within the community (hair saloons, tailors, female clothing stores) act as both a confidential, and non-judgmental resource to answer questions and provide counselling in SRH to study participants.
Experimental: Case Intervention
  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.
Behavioral: Education
Receive educational SMS (text) messages about contraceptive use and family planning on SRH and access individually tailored educational resources through interactive voice response (IVR) services/system via PREVENT mobile platform.
Behavioral: Personal Support
Contact with a female business owner within the community (hair saloons, tailors, female clothing stores) act as both a confidential, and non-judgmental resource to answer questions and provide counselling in SRH to study participants.
Behavioral: Access to contraception
Will be provided by the mobile reproductive health team at contraceptive access points, and, at the health facility partners who will be providing full reproductive health services to program participants and will be the access points for Intra-Uterine Device (IUD) insertion where requested and medically suitable. Results of point of care urine HCG (pregnancy) testing (voluntary at enrollment and mandatory when accessing contraceptive services)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in unmet need for contraceptives at 6 months
Time Frame: 6 month
Percent change in unmet need for contraceptives among study participants using Tanzania Demographic and health survey.
6 month
Change in unmet need for contraceptives at 12 months
Time Frame: 12 month
Percent change in unmet need for contraceptives among study participants using Tanzania Demographic and health survey.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire to test knowledge regarding sexual and reproductive health
Time Frame: 12 month post randomization
Change in health knowledge by participants regarding sexual and reproductive health through engagement with the program using the Family Health International/Pathfinder adolescent fertility questionnaires. Focused on sociodemographic characteristics, levels of sexual activity, knowledge and use of contraceptives, incidence and outcomes of pregnancy, and knowledge and sources of information on reproductive health topics.
12 month post randomization
Change in the number of pregnancies among women at 6 months
Time Frame: 6 month post randomization
Change in unwanted/unplanned pregnancies among participants in the program
6 month post randomization
Change in the number of pregnancies among women at 12 months
Time Frame: 12 month post randomization
Change in unwanted/unplanned pregnancies among participants in the program
12 month post randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants to use voice response and access counseling
Time Frame: 12 months post randomization
Number of beneficiaries who utilize the interactive voice response system and access AFSRH counseling
12 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Karen Yeates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (Actual)

June 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ST-POC-1807-15184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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