Project for Reproductive Equity Through Volunteers and Entrepreneurship, Networks and Technology (PREVENT)

Dr. Karen Yeates

Status: Begins enrollment in 9 months

Conditions: Contraception; Pregnancy Related; Reproductive Behavior

Treatments: Behavioral: Education; Behavioral: Access to contraception; Behavioral: Personal Support

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03995043

ST-POC-1807-15184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 estimated patients

Sex: Female

Ages: 15 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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198 participants in 2 patient groups

Control Intervention

Experimental group

Description:

1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH. 2. Personal Support from community peer mentor to access counselling services through SRH

Treatment:

Behavioral: Personal Support

Behavioral: Education

Case Intervention

Experimental group

Description:

1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH. 2. Personal Support from community peer mentor to access counselling services through SRH 3. Access to Contraception and counselling and service provision will be provided by the mobile reproductive health team at contraceptive access points.

Treatment:

Behavioral: Personal Support

Behavioral: Access to contraception

Behavioral: Education