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ContraceptionPREVENTNCT03995043

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

A study testing Education, Personal Support and Access to contraception in people with Contraception and Pregnancy Related, run by Dr. Karen Yeates at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 15 to 19 years, women onlyHealthy volunteers can take part
What is being tested?
Education, Personal Support and Access to contraception
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
1 siteCanada
Study dates
Dec 2027to 1 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 19 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Karen Yeates, MD contact

6135336730

yeatesk@queensu.ca

Joel Birkemeier, MD contact

4193025370

birkej02@nyu.edu

Canada1 site
  • Queens University

    Kingston, Ontario, K7L 2V7

    Karen E Yeates, MD, 613-533-6730, yeatesk@queensu.ca

    Karen E Yeates, MD

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Education, Personal Support, Access to contraception
Medical subject headings
Reproductive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EducationBehavioural

    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 SupportBehavioural

    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 contraceptionBehavioural

    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)

Study groups in NCT03995043
Study groupRoleWhat they receive
Control InterventionExperimental1. 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
Receives: Behavioral: Education; Behavioral: Personal Support
Case InterventionExperimental1. 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.
Receives: Behavioral: Education; Behavioral: Personal Support; Behavioral: Access to contraception

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in unmet need for contraceptives at 6 months

    Percent change in unmet need for contraceptives among study participants using Tanzania Demographic and health survey.

    Measured: 6 month

  2. Change in unmet need for contraceptives at 12 months

    Percent change in unmet need for contraceptives among study participants using Tanzania Demographic and health survey.

    Measured: 12 month

Secondary outcomes (3)
  1. Questionnaire to test knowledge regarding sexual and reproductive health

    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.

    Measured: 12 month post randomization

  2. Change in the number of pregnancies among women at 6 months

    Change in unwanted/unplanned pregnancies among participants in the program

    Measured: 6 month post randomization

  3. Change in the number of pregnancies among women at 12 months

    Change in unwanted/unplanned pregnancies among participants in the program

    Measured: 12 month post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study startDec 2027 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an individually randomized parallel group study design.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03995043
Sponsor's protocol ID
ST-POC-1807-15184
Acronym
PREVENT
Status last verified
Aug 2026
First submitted
13 Jun 2019
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ministry of Health, Community Development, Gender, Elderly and Children (TZ). Tanzania Demographic and Health Survey and Malaria Indicator Survey (TDHS-MIS) 2015-16 [Internet]. Dar es Salaam: Ministry of Health, Community Development, Gender, Elderly and Children, 2016 [cited 2018 Sept. 19]. 591 p. Available from: https://dhsprogram.com/publications/publication-fr321-dhs-final-reports.cfm

  • Ministry of Health, Community Development, Gender, Elderly and Children (TZ). The National Road Map Strategic Plan to Improve Reproductive, Maternal, Newborn, Child & Adolescent Health in Tanzania (2016-2020) [Internet]. Dar es Salaam: Ministry of Health, Community Development, Gender, Elderly and Children, 2016 [cited 2018 Sept. 19]. 132 p. Available from: https://www.globalfinancingfacility.org/national-road-map-strategic-plan-improve-reproductive-maternal-newborn-child-adolescent-health

  • Rusibamayila A, Phillips J, Kalollela A, Jackson E, Baynes C. Factors influencing pregnancy intentions and contraceptive use: an exploration of the 'unmet need for family planning' in Tanzania. Cult Health Sex. 2017 Jan;19(1):1-16. doi: 10.1080/13691058.2016.1187768. Epub 2016 Jun 14.

    PubMed 27297661
  • Sweya MN, Msuya SE, Mahande MJ, Manongi R. Contraceptive knowledge, sexual behavior, and factors associated with contraceptive use among female undergraduate university students in Kilimanjaro region in Tanzania. Adolesc Health Med Ther. 2016 Oct 3;7:109-115. doi: 10.2147/AHMT.S108531. eCollection 2016.

    PubMed 27757057
  • Sedekia Y, Jones C, Nathan R, Schellenberg J, Marchant T. Using contraceptives to delay first birth: a qualitative study of individual, community and health provider perceptions in southern Tanzania. BMC Public Health. 2017 Oct 3;17(1):768. doi: 10.1186/s12889-017-4759-9.

    PubMed 28974208
  • Kabagenyi A, Reid A, Ntozi J, Atuyambe L. Socio-cultural inhibitors to use of modern contraceptive techniques in rural Uganda: a qualitative study. Pan Afr Med J. 2016 Oct 17;25:78. doi: 10.11604/pamj.2016.25.78.6613. eCollection 2016.

    PubMed 28292041
  • Haslegrave M. Ensuring the inclusion of sexual and reproductive health and rights under a sustainable development goal on health in the post-2015 human rights framework for development. Reprod Health Matters. 2013 Nov;21(42):61-73. doi: 10.1016/S0968-8080(13)42742-8.

    PubMed 24315064
  • Patton GC, Sawyer SM, Santelli JS, Ross DA, Afifi R, Allen NB, Arora M, Azzopardi P, Baldwin W, Bonell C, Kakuma R, Kennedy E, Mahon J, McGovern T, Mokdad AH, Patel V, Petroni S, Reavley N, Taiwo K, Waldfogel J, Wickremarathne D, Barroso C, Bhutta Z, Fatusi AO, Mattoo A, Diers J, Fang J, Ferguson J, Ssewamala F, Viner RM. Our future: a Lancet commission on adolescent health and wellbeing. Lancet. 2016 Jun 11;387(10036):2423-78. doi: 10.1016/S0140-6736(16)00579-1. Epub 2016 May 9. No abstract available.

    PubMed 27174304
  • Gottschalk LB, Ortayli N. Interventions to improve adolescents' contraceptive behaviors in low- and middle-income countries: a review of the evidence base. Contraception. 2014 Sep;90(3):211-25. doi: 10.1016/j.contraception.2014.04.017. Epub 2014 May 4.

    PubMed 24916724
  • L'Engle KL, Mangone ER, Parcesepe AM, Agarwal S, Ippoliti NB. Mobile Phone Interventions for Adolescent Sexual and Reproductive Health: A Systematic Review. Pediatrics. 2016 Sep;138(3):e20160884. doi: 10.1542/peds.2016-0884. Epub 2016 Aug 23.

    PubMed 27553221
  • Ministry of Health and Social Welfare (TZ). National Family Planning Guidelines and Standards [Internet]. Dar es Salaam: Ministry of Health and Social Welfare, 2013 [cited 2018 Sept. 19]. 54 p. Available from: https://www.prb.org/wp-content/uploads/2018/05/National-Family-Planning-Guidelines-and-Standards-2013.Tanzania.pdf

  • Agarwal S, LeFevre AE, Lee J, L'Engle K, Mehl G, Sinha C, Labrique A; WHO mHealth Technical Evidence Review Group. Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist. BMJ. 2016 Mar 17;352:i1174. doi: 10.1136/bmj.i1174. No abstract available.

    PubMed 26988021
  • Bitzer J, Abalos V, Apter D, Martin R, Black A; Global CARE (Contraception: Access, Resources, Education) Group. Targeting factors for change: contraceptive counselling and care of female adolescents. Eur J Contracept Reprod Health Care. 2016 Dec;21(6):417-430. doi: 10.1080/13625187.2016.1237629. Epub 2016 Oct 5.

    PubMed 27701924
  • Cleland J. Illustrative questionnaire for interview-surveys with young people. In: Cleland J, Ingham R, Stone N, eds. Asking Young People About Sexual and Reproductive Behaviors. Illustrative Core Instruments. Geneva: WHO, 2001.

  • Ingham R, Stone N. Topics for In-depth Interviews and Focus Group Discussions: Partner selection, sexual behaviour and risk taking. In: Cleland J, Ingham R, Stone N, eds. Asking young people about sexual and reproductive behaviours: Illustrative Core Instruments. Geneva: WHO, 2001.

Questions about this trial

What is this clinical trial studying?

A study testing Education, Personal Support and Access to contraception in people with Contraception and Pregnancy Related, run by Dr. Karen Yeates at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karen Yeates, MD (6135336730, yeatesk@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in unmet need for contraceptives at 6 months (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03995043, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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