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NCT Number: NCT03995043

Project for Reproductive Equity Through Volunteers and Entrepreneurship, Networks and Technology

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.

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Key information

Conditions

Contraception Behavior Pregnancy Related Reproductive Behavior

Age range

15 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Queens University

Kingston, Ontario, K7L 2V7, Canada

Location contact

Karen E Yeates, MD

CONTACT

[email protected]

613-533-6730

Karen E Yeates, MD

SUB_INVESTIGATOR

Zac Mtema, Phd

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

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.

Personal Support

Behavioral

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.

Access to contraception

Behavioral

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)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Joel Birkemeier, MD

CONTACT

[email protected]

4193025370

Karen Yeates, MD

CONTACT

[email protected]

6135336730

Sponsors and collaborators

Lead sponsor

Dr. Karen Yeates

Other

Registry information

Official study title

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

Acronym: PREVENT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 21, 2019
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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