FM2 first, LAST delayed for Reproductive Health

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Janet S. St. Lawrence, Portland, ORReproductive HealthFamilies Matter 2 - Behavioral
Eligibility
13 - 80
All Sexes
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Study Summary

This trial will test whether a parent and adolescent intervention can help reduce the risk of STIs, HIV, and unintended pregnancies among young people in Botswana.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Families Talking Together Plus (FTT +)
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Momentary Affect Regulation - Safer Sex Intervention (MARSSI)

Study Objectives

11 Primary · 0 Secondary · Reporting Duration: one year

One year
Changes in Parent Use of Positive Reinforcement Scale (parent and youth)
Changes in Parental Monitoring Scale (parent and youth)
Changes in scores on Self Efficacy Beliefs Scale (youth)
Changes in scores on the Condom Attitudes Scale (youth)
Changes on Family Communication Scale (parents and youth)
Changes on Parental Responsiveness Scale (parent and youth)
one year
Change in Attitudes toward Transactional Sex Scale (youth)
Change in number of sex partners (youth and parent)
Changes in Condom Barriers Scale(youth)
Changes in Reproductive Health Knowledge Test scores (youth)
Changes in frequency of unprotected intercourse (youth and parents)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Cope2Thrive
1
Families Talking Together Plus (FTT +)
1
Momentary Affect Regulation - Safer Sex Intervention (MARSSI)

Trial Design

3 Treatment Groups

FM2 first, LAST delayed
1 of 3
FM2 and LAST simultaneous
1 of 3
Comparison arm
1 of 3

Active Control

1000 Total Participants · 3 Treatment Groups

Primary Treatment: FM2 first, LAST delayed · No Placebo Group · N/A

FM2 first, LAST delayedActiveComparator Group · 2 Interventions: Families Matter 2, Living as a Safer Teen · Intervention Types: Behavioral, Behavioral
FM2 and LAST simultaneousActiveComparator Group · 2 Interventions: Families Matter 2, Living as a Safer Teen · Intervention Types: Behavioral, Behavioral
Comparison armActiveComparator Group · 2 Interventions: Families Matter 2, Living as a Safer Teen · Intervention Types: Behavioral, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

Portland State UniversityLead Sponsor
21 Previous Clinical Trials
25,863 Total Patients Enrolled
Esther S Seloilwe, Ph.D.Study DirectorUniversity of Botswana
Janet S St. Lawrence, Ph.D.Principal InvestigatorPortland State University

Eligibility Criteria

Age 13 - 80 · All Participants · 1 Total Inclusion Criteria

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References

Frequently Asked Questions

Is there a call for participants in this clinical investigation?

"Clinicaltrials.gov confirms that this medical study is recruiting patients, having been first posted on April 22nd 2019 and recently updated September 18th 2020." - Anonymous Online Contributor

Unverified Answer

Does this study have an age restriction, and if so is it accommodating individuals over eighty-five?

"This trial seeks to include participants aged 13-80. There are additional specialised trials available for those under 18 and above 65 years old, respectively." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment rate for this research project?

"Affirmative. The information located on clinicaltrials.gov indicates that the trial is actively recruiting patients, having been first posted on April 22nd 2019 and last updated on September 18th 2020. This medical study requires 1000 participants from one site." - Anonymous Online Contributor

Unverified Answer

What is the accepted demographic of participants in this experiment?

"The research team is actively searching for 1000 patients aged 13 to 80 with reproductive health issues, who are located in Gaborone Botswana and have a parent or guardian." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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