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

Pregnancy Related Clinical Trial

— PREVENT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03995043
• Other study ID #: ST-POC-1807-15184
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: Karen Yeates, MD
• Phone: 6135336730
• Email: yeatesk[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 198
• Est. completion date: November 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Pregnancy Related
• Reproductive Behavior

Intervention

Behavioral:
• Education
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
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
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)

Locations

Country	Name	City	State
Canada	Queens University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Karen Yeates

Country where clinical trial is conducted

Canada, 

References & Publications (19)

Agarwal S, LeFevre AE, Lee J, L'Engle K, Mehl G, Sinha C, Labrique A; WHO mHealth Technical Evidence Review Group. Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist. BMJ. 2016 Mar 17;352:i1174. doi: 10.1136/bmj.i1174. No abstract available. — View Citation

Bitzer J, Abalos V, Apter D, Martin R, Black A; Global CARE (Contraception: Access, Resources, Education) Group. Targeting factors for change: contraceptive counselling and care of female adolescents. Eur J Contracept Reprod Health Care. 2016 Dec;21(6):417-430. doi: 10.1080/13625187.2016.1237629. Epub 2016 Oct 5. — View Citation

Cleland J. Illustrative questionnaire for interview-surveys with young people. In: Cleland J, Ingham R, Stone N, eds. Asking Young People About Sexual and Reproductive Behaviors. Illustrative Core Instruments. Geneva: WHO, 2001.

Gottschalk LB, Ortayli N. Interventions to improve adolescents' contraceptive behaviors in low- and middle-income countries: a review of the evidence base. Contraception. 2014 Sep;90(3):211-25. doi: 10.1016/j.contraception.2014.04.017. Epub 2014 May 4. — View Citation

Haslegrave M. Ensuring the inclusion of sexual and reproductive health and rights under a sustainable development goal on health in the post-2015 human rights framework for development. Reprod Health Matters. 2013 Nov;21(42):61-73. doi: 10.1016/S0968-8080(13)42742-8. — View Citation

Ingham R, Stone N. Topics for In-depth Interviews and Focus Group Discussions: Partner selection, sexual behaviour and risk taking. In: Cleland J, Ingham R, Stone N, eds. Asking young people about sexual and reproductive behaviours: Illustrative Core Instruments. Geneva: WHO, 2001.

Johnson D, Juras R, Riley P, Chatterji M, Sloane P, Choi SK, Johns B. A randomized controlled trial of the impact of a family planning mHealth service on knowledge and use of contraception. Contraception. 2017 Jan;95(1):90-97. doi: 10.1016/j.contraception.2016.07.009. Epub 2016 Jul 13. — View Citation

Kabagenyi A, Reid A, Ntozi J, Atuyambe L. Socio-cultural inhibitors to use of modern contraceptive techniques in rural Uganda: a qualitative study. Pan Afr Med J. 2016 Oct 17;25:78. doi: 10.11604/pamj.2016.25.78.6613. eCollection 2016. — View Citation

L'Engle KL, Mangone ER, Parcesepe AM, Agarwal S, Ippoliti NB. Mobile Phone Interventions for Adolescent Sexual and Reproductive Health: A Systematic Review. Pediatrics. 2016 Sep;138(3):e20160884. doi: 10.1542/peds.2016-0884. Epub 2016 Aug 23. — View Citation

Ministry of Health and Social Welfare (TZ). National Family Planning Guidelines and Standards [Internet]. Dar es Salaam: Ministry of Health and Social Welfare, 2013 [cited 2018 Sept. 19]. 54 p. Available from: https://www.prb.org/wp-content/uploads/2018/05/National-Family-Planning-Guidelines-and-Standards-2013.Tanzania.pdf

Ministry of Health, Community Development, Gender, Elderly and Children (TZ). Standard Treatment Guidelines & National Essential Medicines List Tanzania Mainland [Internet]. Dar es Salaam: Ministry of Health, Community Development, Gender, Elderly and Children, 2018 [cited 2018 Sept. 19]. 445 p. Available from: http://www.tzdpg.or.tz/fileadmin/documents/dpg_internal/dpg_working_groups_clusters/cluster_2/health/Key_Sector_Documents/Tanzania_Key_Health_Documents/STANDARD_TREATMENT_GUIDELINES__CORRECT_FINAL_USE_THIS-1.pdf

Ministry of Health, Community Development, Gender, Elderly and Children (TZ). Tanzania Demographic and Health Survey and Malaria Indicator Survey (TDHS-MIS) 2015-16 [Internet]. Dar es Salaam: Ministry of Health, Community Development, Gender, Elderly and Children, 2016 [cited 2018 Sept. 19]. 591 p. Available from: https://dhsprogram.com/publications/publication-fr321-dhs-final-reports.cfm

Ministry of Health, Community Development, Gender, Elderly and Children (TZ). The National Road Map Strategic Plan to Improve Reproductive, Maternal, Newborn, Child & Adolescent Health in Tanzania (2016-2020) [Internet]. Dar es Salaam: Ministry of Health, Community Development, Gender, Elderly and Children, 2016 [cited 2018 Sept. 19]. 132 p. Available from: https://www.globalfinancingfacility.org/national-road-map-strategic-plan-improve-reproductive-maternal-newborn-child-adolescent-health

Patton GC, Sawyer SM, Santelli JS, Ross DA, Afifi R, Allen NB, Arora M, Azzopardi P, Baldwin W, Bonell C, Kakuma R, Kennedy E, Mahon J, McGovern T, Mokdad AH, Patel V, Petroni S, Reavley N, Taiwo K, Waldfogel J, Wickremarathne D, Barroso C, Bhutta Z, Fatusi AO, Mattoo A, Diers J, Fang J, Ferguson J, Ssewamala F, Viner RM. Our future: a Lancet commission on adolescent health and wellbeing. Lancet. 2016 Jun 11;387(10036):2423-78. doi: 10.1016/S0140-6736(16)00579-1. Epub 2016 May 9. No abstract available. — View Citation

Rusibamayila A, Phillips J, Kalollela A, Jackson E, Baynes C. Factors influencing pregnancy intentions and contraceptive use: an exploration of the 'unmet need for family planning' in Tanzania. Cult Health Sex. 2017 Jan;19(1):1-16. doi: 10.1080/13691058.2016.1187768. Epub 2016 Jun 14. — View Citation

Sedekia Y, Jones C, Nathan R, Schellenberg J, Marchant T. Using contraceptives to delay first birth: a qualitative study of individual, community and health provider perceptions in southern Tanzania. BMC Public Health. 2017 Oct 3;17(1):768. doi: 10.1186/s12889-017-4759-9. — View Citation

Sexual Reproductive Health and Rights Africa Trust (ZA). Age of Consent: Legal Review Tanzania Country Report [Internet]. Johannesburg: Sexual Reproductive Health and Rights Africa Trust, 2016 [cited 2018 Sept. 19]. 15 p. Available from: https://www.satregional.org/wp-content/uploads/2018/05/Age-of-consent-Tanzania.pdf

Sweya MN, Msuya SE, Mahande MJ, Manongi R. Contraceptive knowledge, sexual behavior, and factors associated with contraceptive use among female undergraduate university students in Kilimanjaro region in Tanzania. Adolesc Health Med Ther. 2016 Oct 3;7:109-115. doi: 10.2147/AHMT.S108531. eCollection 2016. — View Citation

Vahdat HL, L'Engle KL, Plourde KF, Magaria L, Olawo A. There are some questions you may not ask in a clinic: providing contraception information to young people in Kenya using SMS. Int J Gynaecol Obstet. 2013 Nov;123 Suppl 1:e2-6. doi: 10.1016/j.ijgo.2013.07.009. Epub 2013 Aug 2. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants to use voice response and access counseling	Number of beneficiaries who utilize the interactive voice response system and access AFSRH counseling	12 months post randomization
Primary	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
Primary	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	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
Secondary	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
Secondary	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