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

NCT03995043 | Not Yet Recruiting DMC

• 1 other identifier: ST-POC-1807-15184
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception; Pregnancy Related; Reproductive Behavior

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Questionnaire to test knowledge regarding sexual and reproductive health

  12 month post randomization

• Change in the number of pregnancies among women at 6 months

  6 month post randomization

• Change in the number of pregnancies among women at 12 months

  12 month post randomization

Other Outcomes (1)

• Number of participants to use voice response and access counseling

  12 months post randomization

Study Arms (2)

Control Intervention

EXPERIMENTAL

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

Behavioral: Education; Behavioral: Personal Support

Case Intervention

EXPERIMENTAL

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.

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

Interventions

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.

Case Intervention; Control Intervention

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.

Case Intervention; Control Intervention

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)

Case Intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Gender Eligibility Details: Study dealing with female contraception use and access.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Karen Yeates: lead

Study Sites (1)

Queens University

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (19)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27297661 BACKGROUND

• 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.

  PMID: 27757057 BACKGROUND

• 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.

  PMID: 28974208 BACKGROUND

• 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.

  PMID: 28292041 BACKGROUND

• 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.

  PMID: 24315064 BACKGROUND

• 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.

  PMID: 27174304 BACKGROUND

• 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.

  PMID: 24916724 BACKGROUND

• 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.

  PMID: 27553221 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26988021 BACKGROUND

• 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.

  PMID: 27701924 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27421767 BACKGROUND

• 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.

  PMID: 24012514 BACKGROUND

MeSH Terms

Conditions

Reproductive Behavior

Interventions

Educational Status; Health Services Accessibility

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Karen Yeates, MD

CONTACT

6135336730; yeatesk@queensu.ca

Joel Birkemeier, MD

CONTACT

4193025370; birkej02@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded through the study arm and the outcomes assessor and investigator are blinded to participant group assignment for the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is an individually randomized parallel group study design.

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 21, 2019
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)