Clinical trial NCT03995043: Project for Reproductive Equity Through Volunteers and Entrepreneurship, Networks and Technology
Official title: Project for Reproductive Equity Through Volunteers and Entrepreneurship, Networks and Technology: The PREVENT Project Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Contraception
Pregnancy Related
Reproductive Behavior
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 198
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an individually randomized parallel group study design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

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

Primary outcomes:
measure: Change in unmet need for contraceptives at 6 months
timeFrame: 6 month
measure: Change in unmet need for contraceptives at 12 months
timeFrame: 12 month
Secondary outcomes:
measure: Questionnaire to test knowledge regarding sexual and reproductive health
timeFrame: 12 month post randomization
measure: Change in the number of pregnancies among women at 6 months
timeFrame: 6 month post randomization
measure: Change in the number of pregnancies among women at 12 months
timeFrame: 12 month post randomization
Other outcomes:
measure: Number of participants to use voice response and access counseling
timeFrame: 12 months post randomization
Locations:
city: Kingston
country: Canada
facility: Queens University
state: Ontario
Study officials:
References:
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