- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02103218
A Risky Sex Prevention Intervention for Middle School Age Minority Girls (GEMM)
May 27, 2021 updated by: Dr. Tracy R. Bartlett, University of North Carolina, Greensboro
African American adolescent females are more likely to have sex at an early age, to have older sex partners that have had multiple sexual experiences, and are less likely to use a condom than their white counterparts.
Lack of sexual assertiveness is a factor in the risky sex behaviors of young African American women.
African American girls at the greatest risk for contracting HIV are the ones that report that their partners could convince them to have sex and report trouble communicating their wishes related to sex.
Thus far no intervention has addressed the disparate rate of HIV infection in young African American girls.
This study is unique in promoting increases in racial pride as a component of empowerment to help African American girls self-protect against HIV.
The study has the potential to empower young African American girls to delay sex initiation or reduce risky sex behaviors and thus reduce their risk of contracting HIV.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a longitudinal intervention study with a study condition intervention and a control condition intervention.
Potential participants will be invited to a recruitment meeting.
If they choose to participate, they will be asked to sign informed consent or assent.
There are 4 data collections for moms and girls - 1 after recruitment but before the start of the intervention, 1 at the end of the intervention (after the girls 12 week intervention), 1 three months after the end of the intervention (about 6 months after recruitment), and the final data collection 9 months after the end of the intervention (about 12 months from recruitment).
Girls are asked to attend 12 group intervention sessions of about 2 hours each, once weekly, and then a final termination session that is followed by a celebration session to which their mothers are invited and then an evaluation session.
Moms are asked to participate in 3 one hour education sessions over the 12 weeks that their daughters are in the weekly sessions, the celebration with their daughters, and then their evaluation session.
Moms will also be asked to give their daughter empowering messages 5-7 times/week and girls asked to receive them.
Finally, moms will be asked to receive calls from the study team once per month or 1 year to be asked about the empowering messages they have been sending their daughters.
Study Type
Interventional
Enrollment (Actual)
212
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Greensboro, North Carolina, United States, 27402
- University of North Carolina, Greensboro
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Mother Inclusion Criteria:
- Must be 21 years or older.
- Must be daughter's primary female guardian/caregiver and she lives with me at least 50% of the time.
- Must understand spoken and written English.
- Must be able to provide a phone number where they can be reached and will be able to maintain contact with researchers for one year after start of study.
- Must be able to provide or arrange reliable transportation for their daughter after each session or data collection.
Mother Exclusion Criteria:
- Must not be incarcerated at the time of recruitment
- Must not have a physical or mental health condition that may affect my or my daughter's participation in the study.
Daughter Inclusion Criteria:
- Must be in middle school (grades 6-8) at the time of recruitment.
- Must be between the ages of 11-14 at the time of recruitment.
- Must self-identify as Black, African-American, or a mixed race that includes black or African-American.
- Must be able to understand written and spoken English.
Daughter Exclusion Criteria:
- Must not be in a classroom for developmentally delayed students in school.
- Must not be currently pregnant at the time of recruitment.
- Must not have a mental or physical health condition that may affect her participation in the study.
- Must not be suspended or expelled from school at the time of recruitment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Risky sex prevention
education, activities, empowerment, racial pride building
|
Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.
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Active Comparator: Healthy behaviors
General health education, activities
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Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adolescent Sexual Activity Index
Time Frame: 12 months
|
Adolescent Sexual Activity Index (Female).
The theoretical minimum and maximum values are min=0 and max=10 (Hansen, Paskett, & Carter, 1999).
A higher index value indicates more activity (worse outcome).
|
12 months
|
Any Sex no Condom, Past 3 Months
Time Frame: 12 months
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Any sex no condom, past 3 months
|
12 months
|
Sex With Multiple Partners, Ever
Time Frame: 12 months
|
Sex with multiple partners, ever
|
12 months
|
Drugs/Alcohol Use During Sex, Past 3 Months
Time Frame: 12 months
|
Drugs/Alcohol use during sex, past 3 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Knowledge
Time Frame: 12 month
|
HIV-Knowledge Questionnaire for Adolescent Girls.
The theoretical minimum and maximum values are min=0 and max=18.
Higher scores indicate higher HIV knowledge which is a better outcome.
|
12 month
|
Maternal Bond Scale
Time Frame: 12 months
|
Maternal Bond Scale.
The theoretical minimum and maximum are min=8 to max=40.
Higher scores indicate stronger maternal bonds which is a better outcome.
|
12 months
|
Mother-Teen Sexual Risk Communication
Time Frame: 12 months
|
Mother-Teen Sexual Risk Communication.
The theoretical minimum and maximum are min=8 to max=40.
Higher scores indicate greater mother-teen communication about sexual risk which is a better outcome.
|
12 months
|
Mother-Adolescent Communication: Open Family Communication (Girl)
Time Frame: 12 months
|
Mother-Adolescent Communication: Open Family Communication (Girl).
The theoretical minimum and maximum values are min=10 and max=50.
A higher value indicates greater mother-adolescent open family communication which is a better outcome.
|
12 months
|
Maternal Monitoring Scale (Girl)
Time Frame: 12 months
|
Maternal Monitoring Scale (Girl).
The theoretical minimum and maximum values are min=8 and max=40.
A higher value indicates greater maternal monitoring which is a better outcome.
|
12 months
|
Rosenberg Self-Esteem
Time Frame: 12 months
|
Rosenberg Self-Esteem Scale.
The theoretical minimum and maximum values are min=10 and max=40.
A higher value indicates higher self-esteem which is a better outcome.
|
12 months
|
Racial Pride
Time Frame: 12 months
|
Racial Pride Scale.
The theoretical minimum and maximum values are min=7 and max=28.
A higher value indicates stronger feelings of racial pride which is a better outcome.
|
12 months
|
Empowerment: Interpersonal
Time Frame: 12 months
|
Empowerment Scale: Interpersonal.
The theoretical minimum and maximum values are min=4 and max=20.
A higher value indicates greater personal influence on relationship decisions.
|
12 months
|
Empowerment: Relationship
Time Frame: 12 months
|
Empowerment Scale: Interpersonal.
The theoretical minimum and maximum values are min=3 and max=21.
A higher value indicates greater influence over a partner.
|
12 months
|
Empowerment: Personal
Time Frame: 12 months
|
Empowerment Scale: Personal.
The theoretical minimum and maximum values are min=3 and max=21.
A higher value indicates greater personal empowerment.
|
12 months
|
Sexual Assertiveness: Refusal
Time Frame: 12 months
|
Sexual Assertiveness Refusal subscale.
The theoretical minimum and maximum scores are min=6 and max=30.
Higher scores indicate greater assertiveness in refusing sexual activity (better outcome).
|
12 months
|
Sexual Assertiveness: Prevent
Time Frame: 12 months
|
Sexual Assertiveness Prevent subscale.
The theoretical minimum and maximum scores are min=6 and max=30.
Higher scores indicate greater assertiveness in taking measures to prevent pregnancy (better outcome).
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12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mother Adolescent Communication: Open Family Communication (Mother)
Time Frame: 12 months
|
Mother Adolescent Communication: Open Family Communication (Mother).
The theoretical minimum and maximum values are min=10 and max=50.
A higher value indicates greater mother-adolescent open family communication which is a better outcome.
|
12 months
|
Maternal Monitoring Scale (Mother)
Time Frame: 12 months
|
Maternal Monitoring Scale (Mother).
The theoretical minimum and maximum values are min=8 and max=40.
A higher value indicates greater maternal monitoring which is a better outcome.
|
12 months
|
Communication About Sex Self-Efficacy Scale
Time Frame: 12 months
|
Communication about Sex Self-Efficacy Scale.
The theoretical minimum and maximum scores are min=12 and max=60.
Higher scores indicate greater self-efficacy (better outcome).
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tracy R Bartlett, PhD, University of North Carolina, Greensboro
- Study Chair: Debra C Wallace, PhD, Univeristy of North Carolina, Greensboro
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wallace DC, Bartlett R. Recruitment and retention of African American and Hispanic girls and women in research. Public Health Nurs. 2013 Mar;30(2):159-66. doi: 10.1111/phn.12014. Epub 2012 Nov 22.
- Bartlett R, Johnson A, Randolph I, McCoy TP. Communication and Bonding Between African-American Middle School Girls and Their Maternal Figures. J Natl Black Nurses Assoc. 2016 Jul;27(1):18-23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
February 13, 2018
Study Completion (Actual)
February 13, 2018
Study Registration Dates
First Submitted
March 31, 2014
First Submitted That Met QC Criteria
April 2, 2014
First Posted (Estimate)
April 3, 2014
Study Record Updates
Last Update Posted (Actual)
June 16, 2021
Last Update Submitted That Met QC Criteria
May 27, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P20MD002289-1
- P20MD002289 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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