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

N/ANot Yet RecruitingNCT03995043

Dr. Karen Yeates198 enrolled

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.

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.

Study Type

INTERVENTIONAL

Interventions

EducationBEHAVIORAL

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 SupportBEHAVIORAL

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 contraceptionBEHAVIORAL

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)

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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.

Time frame: 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.

Time frame: 12 month

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.

Time frame: 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

Time frame: 6 month post randomization

Change in the number of pregnancies among women at 12 months