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

No phase Interventional Contraception Pregnancy Related Reproductive Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Education, Personal Support, Access to contraception.
Who it may be relevant to
Registry conditions: Contraception, Pregnancy Related, Reproductive Behavior. Basic parameters: 15 years — 19 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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)

Primary outcome measures

  • Change in unmet need for contraceptives at 6 months [Time frame: 6 month]
  • Change in unmet need for contraceptives at 12 months [Time frame: 12 month]
Secondary outcome measures (3)
  • Questionnaire to test knowledge regarding sexual and reproductive health [Time frame: 12 month post randomization]
  • Change in the number of pregnancies among women at 6 months [Time frame: 6 month post randomization]
  • Change in the number of pregnancies among women at 12 months [Time frame: 12 month post randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Health services research

Study locations

Canada · 1 center
  • Queens University — Kingston

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/
  • 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 27174304

Identifiers

NCT: NCT03995043 · ST-POC-1807-15184

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗