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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • North Carolina
      • Greensboro, North Carolina, United States, 27402
        • University of North Carolina, Greensboro

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Risky sex prevention
education, activities, empowerment, racial pride building
Behavioral: Education, activities, empowerment, racial pride building
Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.
Active Comparator: Healthy behaviors
General health education, activities
Behavioral: General Health education, activities
Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Greensboro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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