Clinical Trials Logo

Clinical Trial Summary

This study uses a randomized controlled trial (RCT) design to evaluate the impacts of the Future Foundation (FF) 2.0 Personal Responsibility Education Innovative Strategies (PREIS) program on reducing students' sexual activity (vaginal), recent risking sexual activity without condom use, and unprotected sex (no condoms/contraceptives). FF will implement the 2.0 PREIS Program with three cohorts of African-American youth in the 6th to 8th grades. FF aims to recruit and enroll 400 students who are new to the program for Cohort 1, 150 new students for Cohort 2, and another 150 new students for Cohort 3. These cohorts of eligible students will come from grades 6-8 in Woodland and McNair middle schools and projected to attend Banneker high school. Random assignment will be an ongoing process throughout the project enrollment periods. By the end of the recruitment processes, a total of 700 students will be randomly assigned to either the treatment or the control group, resulting in 350 students in each condition. Each year, the FF 2.0 PREIS intervention model will offer year-round grant-funded services, including after-school, summer programming, and parent engagement activities. The 350 youth randomly assigned to the treatment group will be offered the FF 2.0 PREIS program (Cohort 1 will target 200 treatment youth from January 2018 through June 2018; Cohort 2 will target 75 treatment youth from August 2018 through May 2019; and Cohort 3 will serve 75 treatment youth from August 2019 through May 2020.), while the 350 students assigned to the control group may receive after school and/or summer programming from another community-based organization. The primary hypotheses for the RCT study are the following: significantly fewer numbers of students in the FF 2.0 PREIS intervention engage in vaginal sex than their control group peers do by the time of the end of the program and also at the six-month follow-up; significantly fewer numbers of students in the FF 2.0 PREIS intervention engage in recent unprotected sex significantly than the control group students do at the end of the program and also at the six-month follow-up; and significantly greater numbers of participants in the FF 2.0 PREIS intervention remain abstinent or report condom use during recent vaginal sexual activity than the control group students do at the end of the program and also at the six-month follow-up.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03729726
Study type Interventional
Source Metis Associates, Inc.
Contact Jing Zhu, Ph.D.
Phone 2124258833
Email jzhu@metisassoc.com
Status Recruiting
Phase N/A
Start date May 11, 2017
Completion date October 2021

See also
  Status Clinical Trial Phase
Completed NCT02579135 - Reducing HIV Risk Among Adolescents: Evaluating Project HEART N/A
Completed NCT04121962 - A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence) N/A
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Recruiting NCT05889689 - Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters N/A
Not yet recruiting NCT06007534 - Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments N/A
Completed NCT02516930 - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China N/A
Completed NCT03063385 - Puerto Rico Cuidalos Parent-adolescent Program N/A
Completed NCT02009046 - Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students N/A
Completed NCT01411878 - Louisville Teen Pregnancy Prevention Project N/A
Completed NCT01303575 - Internet-Based Sexual Health Education for Middle School Native American Youth N/A
Completed NCT00167505 - All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students N/A
Completed NCT00183456 - A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs Phase 2
Completed NCT00336180 - Adolescent Drug and HIV Prevention in South Africa Phase 2/Phase 3
Completed NCT01084395 - Reducing HIV Risk Among Mexican Youth N/A
Completed NCT00161382 - Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students N/A
Completed NCT00710060 - Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations Phase 3
Completed NCT00640653 - Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents N/A
Completed NCT00289939 - Reducing HIV & Domestic Violence Risk in Women Offenders Phase 3
Completed NCT00137943 - Parents Matter!: Interventions to Promote Effective Parent-Child Communication Phase 1
Completed NCT03408743 - Engineering an Online STI Prevention Program: CSE2 N/A