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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-19
SponsorDr. Karen Yeates

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Education

    Behavioral

    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 Support

    Behavioral

    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 contraception

    Behavioral

    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)

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Control InterventionExperimental treatment 2 interventions
Group B: Case InterventionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
12 month

Secondary outcomes

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.

Time frame
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

Time frame
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

Time frame
12 month post randomization

Other outcomes

1

Number of participants to use voice response and access counseling

Number of beneficiaries who utilize the interactive voice response system and access AFSRH counseling

Time frame
12 months post randomization

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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