AzTrials
AzTrials

HIVGEMMNCT02103218

A Risky Sex Prevention Intervention for Middle School Age Minority Girls

A study testing Education, activities, empowerment, racial pride building and General Health education, activities in people with HIV and Risky Sex Prevention, run by University of North Carolina, Greensboro at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 11 to 99 years, women only
Conditions the study is for
HIV, Risky Sex Prevention
What is being tested?
Education, activities, empowerment, racial pride building and General Health education, activities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteUnited States
Study dates
Nov 2012to 13 Feb 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 99 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina, Greensboro

    Greensboro, North Carolina, 27402

Other trials in United States

About this study

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.

Read the 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.

Being tested
Education, activities, empowerment, racial pride building, General Health education, activities
Keywords
HIV, risky sex prevention, intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education, activities, empowerment, racial pride buildingBehavioural

    Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.

  • General Health education, activitiesBehavioural

    Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).

Study groups in NCT02103218
Study groupRoleWhat they receive
Risky sex preventionExperimentaleducation, activities, empowerment, racial pride building
Receives: Behavioral: Education, activities, empowerment, racial pride building
Healthy behaviorsActive comparatorGeneral health education, activities
Receives: Behavioral: General Health education, activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adolescent Sexual Activity Index

    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).

    Measured: 12 months

  2. Any Sex no Condom, Past 3 Months

    Any sex no condom, past 3 months

    Measured: 12 months

  3. Sex With Multiple Partners, Ever

    Sex with multiple partners, ever

    Measured: 12 months

  4. Drugs/Alcohol Use During Sex, Past 3 Months

    Drugs/Alcohol use during sex, past 3 months

    Measured: 12 months

Secondary outcomes (12)

  1. HIV Knowledge

    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.

    Measured: 12 month

  2. Maternal Bond Scale

    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.

    Measured: 12 months

  3. Mother-Teen Sexual Risk Communication

    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.

    Measured: 12 months

  4. Mother-Adolescent Communication: Open Family Communication (Girl)

    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.

    Measured: 12 months

  5. Maternal Monitoring Scale (Girl)

    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.

    Measured: 12 months

  6. Rosenberg Self-Esteem

    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.

    Measured: 12 months

  7. Racial Pride

    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.

    Measured: 12 months

  8. Empowerment: Interpersonal

    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.

    Measured: 12 months

  9. Empowerment: Relationship

    Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner.

    Measured: 12 months

  10. Empowerment: Personal

    Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment.

    Measured: 12 months

  11. Sexual Assertiveness: Refusal

    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).

    Measured: 12 months

  12. Sexual Assertiveness: Prevent

    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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2014 (estimated)
  2. Study startNov 2012
  3. Primary completion13 Feb 2018
  4. Study completion13 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02103218
Sponsor's protocol ID
P20MD002289-1
Other IDs
P20MD002289
Acronym
GEMM
Status last verified
May 2021
First submitted
31 Mar 2014
Last updated
16 Jun 2021
Data monitoring committee
Yes

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.

    PubMed 23452110

  • 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.

    PubMed 29932539

Questions about this trial

What is this clinical trial studying?

A study testing Education, activities, empowerment, racial pride building and General Health education, activities in people with HIV and Risky Sex Prevention, run by University of North Carolina, Greensboro at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adolescent Sexual Activity Index (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02103218, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.

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