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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception, Pregnancy Related, Reproductive Behavior

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Personal Support
* Behavioral: Access to contraception


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an individually randomized parallel group study design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Intervention<br>Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH. Personal Support from community peer mentor to access counselling services through SRH | Behavioral: Education<br>* 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.<br>Behavioral: Personal Support<br>* 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.<br>|
| Experimental: Case Intervention<br>Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH. Personal Support from community peer mentor to access counselling services through SRH Access to Contraception and counselling and service provision will be provided by the mobile reproductive health team at contraceptive access points. | Behavioral: Education<br>* 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.<br>Behavioral: Personal Support<br>* 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.<br>Behavioral: Access to contraception<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 month | 
| 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. | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 month post randomization | 
| Change in the number of pregnancies among women at 6 months | Change in unwanted/unplanned pregnancies among participants in the program | 6 month post randomization | 
| Change in the number of pregnancies among women at 12 months | Change in unwanted/unplanned pregnancies among participants in the program | 12 month post randomization |