Comprehensive Reproductive Support Program for Pregnancy Prevention

(PREVENT Trial)

Overseen By Joel Birkemeier, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Dr. Karen Yeates

Disqualifiers: Pregnancy, Long-term contraception, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

198 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing contraceptive services and education, so it's best to discuss your specific medications with the study team.

What data supports the effectiveness of this treatment for pregnancy prevention?

Research shows that educational programs can improve knowledge and attitudes, reduce stress, and enhance engagement in treatment. These findings suggest that similar educational and support interventions could be effective in helping individuals make informed decisions about pregnancy prevention. ^{1 2 3 4 5}

Is the Comprehensive Reproductive Support Program for Pregnancy Prevention safe for humans?

The research on educational interventions for contraception, which is part of the Comprehensive Reproductive Support Program, shows that these programs are generally safe as they focus on increasing knowledge and decision-making skills without involving any physical treatments or medications. ^{6 7 8 9 10}

How does the Comprehensive Reproductive Support Program for Pregnancy Prevention differ from other treatments?

This treatment is unique because it focuses on education, including coping and mental health education, to prevent pregnancy, rather than relying solely on medical or contraceptive methods. It emphasizes teaching decision-making and negotiation skills, which can empower individuals to make informed choices about their reproductive health. ^{7 11 12 13 14}

What is the purpose of 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

The PREVENT Project is for girls aged 15-19 living in Kilimanjaro, Tanzania who can read SMS texts in English or Swahili. They must have a mobile phone, be willing to participate for 12 months, and not be pregnant nor planning pregnancy within the year. Girls using long-term contraception or with cognitive delays are excluded.

Inclusion Criteria

Be able and willing to return for follow-up after 12 months

Have a personal mobile phone and be willing to provide the phone number to the researchers to receive the intervention messages

I am a woman between 15 and 19 years old.

Exclusion Criteria

Be pregnant or planning pregnancy within 12 months (assessed when obtaining consent using HCG (human chorionic gonadotropin) urine dipstick)

Already utilizing a long-term form of contraception such as intra-uterine device, or implantable or inject-able contraception

Participation in another study or intervention that may affect the outcome of this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive educational SMS messages, access to interactive voice response services, and personal support from community peer mentors. The case group also receives access to contraception and counseling services.

12 months

Follow-up

Participants are monitored for changes in SRH knowledge, contraceptive use, and pregnancy outcomes.

12 months

Treatment Details

Interventions

• Access to contraception
• Education
• Personal Support

Trial Overview This study tests an educational program on reproductive health via text messages and voice services. It connects participants to local support and discreet contraceptive access points. The case group receives additional personal support and access to contraceptives through the program.

Participant Groups

Group I: Control Intervention Experimental Treatment 2 Interventions

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

Group II: Case Intervention Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Dr. Karen Yeates

Lead Sponsor

Trials

2

Recruited

3,200+

Dr. Karen Yeates

Lead Sponsor

Trials

2

Recruited

3,200+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Findings from Research

A quality improvement project involving 124 psychiatric patients showed that individualized safety plans created during inpatient treatment were well-tailored, scoring an average of 32.85 out of 44 on a customization rubric.

Postdischarge, 96.1% of patients retained their safety plans, and 36.8% reported using them, with 67.9% of those users finding the plans helpful, indicating that these plans can support recovery after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. Leonard, J., Chiappetta, L., Stark, S., et al.[2023]

All five reviewed adolescent pregnancy prevention programs effectively emphasized abstinence, decision-making skills, and education on sexuality and contraception, with four providing access to contraceptive services.

Programs targeting younger adolescents were particularly successful, reducing sexual initiation by up to 15 percentage points and increasing contraceptive use by as much as 22 percentage points, with the most effective programs also significantly decreasing pregnancy rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the impact of effective teenage pregnancy prevention programs. Frost, JJ., Forrest, JD.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A program of supported education for adult Israeli students with schizophrenia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Educating relatives about schizophrenia. [2019]

4. France pubmed.ncbi.nlm.nih.gov

[Psychoeducation, a project of therapeutic alliance for nursing staff and families]. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Specific and non-specific effects of educational intervention with families living with a schizophrenic relative. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of Contraceptive Education on Contraceptive Knowledge and Decision Making: A Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Integration of a Comprehensive Contraception Education Program Into Clinical Practice in a Family Planning Clinic. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Young women's preferences for contraceptive education & development of an online educational resource. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Reproductive health education program for Mexican women. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of Contraceptive Education on Knowledge and Decision Making: An Updated Systematic Review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Sexuality and life skills education. A multistrategy intervention in Mexico. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Understanding the impact of effective teenage pregnancy prevention programs. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

The intrauterine device and its dynamics. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Innovations in adolescent reproductive and sexual health education in Santiago de Chile: effects of physician leadership and direct service. [2017]