View clinical trials related to Pregnancy in Adolescence.
Filter by:The study will utilize an exploratory study design, applying formative research methods to inform the development and pilot testing of an unintended teen pregnancy prevention intervention.
Pregnant adolescents living with HIV (ALHIV) in Kenya frequently experience stigma and difficulty telling a family member about their HIV and pregnancy status. This study will develop and evaluate a digital intervention for pregnant unmarried ALHIV to address the effects of stigma and strengthen communication skills. Family caregivers are an important yet underappreciated and understudied source of social support for pregnant unmarried ALHIV. The study will also identify acceptable approaches to involve family caregivers in addressing the detrimental effects of the intersecting stigmas faced by pregnant ALHIV. Together, these approaches are expected to improve engagement in PMTCT services among pregnant ALHIV. The study specific aims are to: (1) Develop and evaluate a digital intervention for pregnant unmarried ALHIV aged 15-19 to increase awareness of stigma and its consequences; improve disclosure self-efficacy and skills; and facilitate enlistment of family caregivers as social support allies to enhance uptake of PMTCT services; and (2) Identify acceptable approaches to increase awareness about stigma and enhance skills in communication and provision of social support among family caregivers. We will use data from individual interviews with pregnant ALHIV and joint interviews with pregnant ALHIV/caregiver dyads to develop initial intervention specifications and mock-ups. We will then conduct focus groups to obtain feedback on sample materials in order to refine the materials and develop an intervention prototype. We will then conduct a pilot to evaluate acceptability, usability, and preliminary efficacy of the prototype. All participating adolescents will receive a session in using the digital intervention with a mobile phone. The research team will ask questions both before the session and two weeks after the session in order to assess the intervention's usability and acceptability and preliminary improvements in the adolescents regarding stigma, disclosure, and social support. We will conduct focus groups with caregivers to identify acceptable approaches to involve them. Data will be used to finalize content and specifications of the digital intervention for pregnant ALHIV and will provide the framework for a future complementary intervention for caregivers, which will both be tested in a larger R34 or R01 trial.
The New Jersey Physicians Advisory Group (NJPAG) previously created the Yes You Can…Make Smart Choices! (YYC…MSC!) program with the goal of preventing teen pregnancy and enhancing character development in youth. YYC…MSC! is a fully developed intervention that NJPAG has experience implementing that is grounded in a theoretical framework with promising evidence of effectiveness. However, this intervention has not yet undergone a rigorous evaluation with a control or comparison group. This evaluation aims to conduct a randomized control trial (RCT) to determine the program's effectiveness. This evaluation will focus on the entire PREIS planned intervention, YYC…MSC!. The intervention will be implemented in 13 Newark Public Schools in New Jersey, including Weequahic High School and Newark School of Global Studies. Findings from this study will expand the evidence base on adolescent pregnancy prevention through this innovative program. After the study, findings will be disseminated to encourage program interest, support, and adoption in real-world service systems or communities, including schools. The primary research question is, "What is the effect of the 2-week YYC…MSC! program on 9th grade students in Northeast urban school districts' reports of engaging in sexual intercourse 12-months after the pre-survey compared to those that do not receive the program?" The outcome for the primary research questions is sexual intercourse in the last 3 months and the domain is sexual activity.
TRAIL is a multi-tiered school-wide intervention delivered to middle and high school aged youth. The overall goal of the TRAIL project is to decrease rates of teen births by increasing the capacity of students to make healthy decisions regarding sexual health through the use of a school-wide pregnancy prevention model. The program will be delivered to youth in eighth and ninth grade at the intervention sites.
A culturally tailored program that creates a safe, open space to increase knowledge, self-efficacy, skills, and comfort related to sexual and reproductive health, including HIV/STI and teen pregnancy prevention, mental health, and substance use risk reduction behavior, and strengthens protective factors, decision-making skills, and connections to trusted adults may help participants chart a path toward optimal health. To address a significant gap in evidence-based, culturally-tailored sexual and reproductive health services for Black and African American adolescents, Public Health Management Corporation (PHMC) is conducting a rigorous evaluation of an innovative group-level, two pronged intervention called Talking Matters using an individual randomized control trial (RCT) design. Due to social distancing guidelines during COVID-19 at the start of the study, all Talking Matters activities, including recruitment, screening, consent, intervention implementation, and data collection, will be conduct virtually and remotely. Developed and piloted over the past two years through FY2018 Phase I New and Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence funding from the Office of Population Affairs (OPA), Talking Matters is a promising group-level, two-pronged intervention tailored for urban Black and African American 14 to 19 year old adolescents who are recruited from school- and community-based settings in Philadelphia, PA. Grounded in Social Cognitive Theory, the Transtheoretical Model, and Self-Determination Theory, and using evidence-based Motivational Interviewing strategies, the primary goals of Talking Matters are to reduce adolescents' risk for teen and unplanned pregnancy, sexually transmitted infections (STIs) and HIV, and to strengthen protective factors improve optimal health. The two prongs of Talking Matters include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT). An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. Adult participants of the LTRT training are not human subjects of the Talking Matters study.
Black adolescents who are pregnant represent a high-risk and understudied perinatal population in health research. Adolescent pregnancy (<20 years) is disproportionately prevalent among Blacks compared with Whites and is a prominent risk factor for obesity. Fortunately, metabolic consequences of increasing physical activity coupled with minimal sedentary time can mitigate biological imperils and behavioral interventions targeting perinatal populations have demonstrated efficacy for this approach. Intervention studies to promote physical activity and reduce sedentarism among Black, perinatal adolescents in disadvantaged, rural settings may be a promising strategy to prevent obesity and reduce disparities. In the proposed study, investigators will assess the feasibility and acceptability of #BabyLetsMove, a mobile health intervention targeting three behavioral goals: (1) limit TV time to less than 2 hours a day (sedentary behavior); (2) take 10,000 steps or more per day (physical activity); and (3) do 20 minutes or more of structured activity like prenatal yoga or dance videos per day (exercise). In the #BabyLetsMove feasibility trial investigators aim to conduct a single-arm, 4-week pilot with 20 Black adolescents (15- to 19-years) enrolled in Mississippi's Supplemental Nutritional Program for Women, Infants and Children (WIC) to test the intervention's feasibility and acceptability. Participants will receive one text message per day for 4-weeks targeting behavior change strategies and two health coaching sessions via mobile phone; an introduction session in week one and a problem-solving session in week three. Investigators will also use qualitative interviewing with additional adolescents (n=20) to solicit user feedback regarding the acceptability of intervention content and materials. Finally, in preparation for a pilot study using an effectiveness-implementation hybrid study design, investigators will conduct a pre-implementation evaluation using quantitative surveying (n=6 surveys) with WIC providers (n=60) to better under the culture and climate of WIC. Investigators hypothesize the #BabyLetsMove intervention will be acceptable to adolescents and a future pilot randomized controlled trial will be feasible. Investigators also anticipate identifying modifiable barriers and facilitators to implementing the intervention through WIC, which will help to design an implementation strategy with a high likelihood for uptake by WIC.
This protocol describes an evaluation of the CyberRwanda program, a digital health tool designed with and for adolescents in Rwanda, with a focus on successful futures, broadly, and family planning and reproductive health, more specifically. CyberRwanda is a tablet-based system that provides information on family planning and reproductive health through a set of vignettes. The program also allows users to order and purchase contraceptives, with pick up at nearby participating pharmacies. The program will be implemented in schools in eight districts in Rwanda. The investigators will conduct a 3-arm, cluster, randomized controlled trial to evaluate the impact of CyberRwanda on three primary outcomes: uptake of a contraceptive method, initiation of childbearing, and HIV testing. The investigators will compare two implementation models (facilitated and self-service) to a control arm at the school (cluster) level. The study will enroll 60 schools (20 per arm) and 100 students per school, and follow students for 24 months.
This multi-site study is employing a brief contraception counseling intervention in the Emergency Department (ED) to shed light on factors that affect decision making as well as barriers and facilitators to conception initiation in the Emergency Department (ED) setting. The overarching goal of the study is to reduce unintended pregnancy among females ages 15 to 18 who present to the Emergency Department (ED).
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.
A randomized controlled trial is being conducted in high schools in North Carolina and New York City to determine the impact of a school-based, positive youth development program on sexual behaviors associated with teen pregnancy