About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Education
BehavioralReceive 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
BehavioralContact 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
BehavioralWill 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)
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
Change in the number of pregnancies among women at 6 months
Change in unwanted/unplanned pregnancies among participants in the program
Change in the number of pregnancies among women at 12 months
Change in unwanted/unplanned pregnancies among participants in the program
Other outcomes
Number of participants to use voice response and access counseling
Number of beneficiaries who utilize the interactive voice response system and access AFSRH counseling
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Karen Yeates
Lead sponsor
Queen's University
Sponsor institution
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