- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01553682
Project N-Liten- HIV Prevention for African American Women
June 24, 2015 updated by: Ralph J. DiClemente, Emory University
Reducing Alcohol-Related HIV Risk in African American Females
Young African-American women who report a higher frequency of alcohol use have particularly higher rates of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV) sex behaviors.
Unfortunately, there are no evidence-based HIV interventions designed to be gender- and culturally-appropriate for this population.
To address this, the investigators propose to add to the CDC-defined evidence-based intervention (DEBI), Horizons, a new intervention form, Group Motivational Enhancement Therapy (GMET), which has shown promise in reducing alcohol use and alcohol-related HIV risk-taking.
To test how effective the combined Horizons+GMET alcohol-specific portion is, it will be evaluated with a time equivalent Horizons+attention control general health promotion (GHP) portion focusing on nutrition health promotion, and to an enhanced standard-of-care program.
In this study, 600 young African American women, 18-24 years of age, who report 3 or more occasions where they drank alcohol in the past 90 days will be recruited to complete a four-part baseline assessment consisting of: 1. an audio computer assisted self interview (ACASI), 2. videotaped communication role plays to objectively measure communication skill ability (subsample), 3. provide a vaginal specimen to test for STDs and 4. Provide a urine pregnancy screen.
After participants complete their baseline assessment, they will be randomly assigned to one of three conditions: 1. Horizons+GMET alcohol-specific condition, 2. a time-equivalent Horizons+GHP condition, or 3. an enhanced standard-of-care control condition.
The GMET alcohol-specific component has shown to be effective in influencing several alcohol-specific concepts (attitudes, norms, self-efficacy) and reducing sexual risk-taking among culturally-diverse high-risk youth.
The GMET alcohol-specific module was designed to increase woman's awareness of the unfavorable effects of alcohol on themselves, their sexual decision-making, and their male partner and teaches women strategies to reduce the possibility of engaging in sex under the influence of alcohol.
In addition, the GMET alcohol-specific module provides skills training needed to effectively talk about sexual intentions to use condoms and/or refuse risky sex when they or their male sex partner has been using alcohol.
After completing one of the three conditions, participants will complete a brief ACASI posttest to evaluate immediate changes in hypothesized social and psychological mediators of safer sex and alcohol use.
Participants will also return to complete follow-up assessments at 3, 6, 9, and 12-months after their intervention.
If the Horizons+GMET intervention is observed to be effective, investigators will work closely with the CDC DEBI program to help distribute the intervention to public health agencies and community based organizations (CBOs).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
560
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
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
-
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
18 years to 24 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
To be eligible, participants must be:
- African American women;
- 18-24 years of age, inclusive at time of enrollment;
- unmarried;
- report having at least one episode of unprotected vaginal or anal sex in the past 90 days;
- report ≥ 3 alcohol drinking episodes in the past 90 days;
- not pregnant; and
- provide written informed consent.
Exclusion Criteria:
Those with:
- the presence of active psychosis reflected by the participant's status during the baseline assessment, and/or
- an acute or chronic illness that could preclude participation for the duration of the program and follow-up will be excluded.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Enhanced Standard-Of-Care
Participants will watch a video about how to prevent STIs and HIV, then do question and answer session.
This group will be last 1 hour.
It will be led by one African American health educator, and have about 4-8 other young women participants.
Participants will be asked to rate the workshop anonymously.
|
|
Active Comparator: Horizons+General Health Promotion (GHP)
Participants will attend the Horizons HIV Prevention Program with an extra workshop on nutrition health promotion.
Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays.
They will be led by African American health educators, and have about 8-12 other young women participants.
The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior.
The nutrition health promotion workshop will give ideas on healthy nutrition and exercise.
Participants will be asked to rate the workshop anonymously.
|
Participants will attend the Horizons HIV Prevention Program with an extra workshop on nutrition health promotion.
Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays.
They will be led by African American health educators, and have about 8-12 other young women participants.
The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior.
The nutrition health promotion workshop will give ideas on healthy nutrition and exercise.
Participants will be asked to rate the workshop anonymously.
|
Experimental: Horizons+Motivational Enhancement Therapy (GMET)
Participants will attend the Horizons Plus HIV Prevention Program.
Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays.
They will be led by African American health educators, and have about 8-12 other young women participants.
The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior.
Participants will be asked to rate the workshop anonymously.
|
Participants will attend the Horizons Plus HIV Prevention Program.
Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays.
They will be led by African American health educators, and have about 8-12 other young women participants.
The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior.
Participants will be asked to rate the workshop anonymously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incident STD infection confirmed by laboratory PRC testing over a 12-month follow-up.
Time Frame: 12 months post-randomization
|
Incident STD infection confirmed by laboratory PRC testing.
|
12 months post-randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of condom-protected vaginal or anal sex acts over a 12-month follow-up.
Time Frame: 12 months post-randomization
|
Assessed by ACASI
|
12 months post-randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ralph J DiClemente, PhD, Emory University
- Principal Investigator: Jennifer L. Monahan, PhD, University of Georgia
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.
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
December 1, 2011
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
March 5, 2012
First Submitted That Met QC Criteria
March 12, 2012
First Posted (Estimate)
March 14, 2012
Study Record Updates
Last Update Posted (Estimate)
June 25, 2015
Last Update Submitted That Met QC Criteria
June 24, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00048502
- 5R01AA018096 (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.
Clinical Trials on Sexually Transmitted Diseases
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID)RecruitingSTI | Sexually Transmitted Disease (STD) | Sexually Transmitted Infection (STI)United States
-
National Institute of Allergy and Infectious Diseases...Terminated
-
Boston Medical CenterCompletedSexually Transmitted InfectionUnited States
-
University of ChicagoCompletedSexually Transmitted InfectionUnited States
-
University of California, San FranciscoNational Institute of Mental Health (NIMH); MRC/UVRI and LSHTM Uganda Research... and other collaboratorsCompletedSexually Transmitted InfectionUganda
-
Assistance Publique Hopitaux De MarseilleCompletedSexually Transmitted InfectionFrance
-
University of Illinois at ChicagoEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHiv | Sexually Transmitted InfectionSouth Africa
-
Boston Medical CenterCompletedSexually Transmitted InfectionUnited States
-
Sagami Rubber Industries Co., Ltd.Essential Access HealthCompletedContraception | Prevention of Sexually Transmitted InfectionsUnited States
-
NYU Langone HealthCompletedHiv | Sexually Transmitted InfectionUnited States
Clinical Trials on Horizons+General Health Promotion (GHP)
-
University of RochesterCenters for Disease Control and PreventionNot yet recruitingWell-Being, PsychologicalUnited States
-
Rhode Island HospitalCompletedHIV InfectionsUnited States
-
Rhode Island HospitalCompleted
-
Rhode Island HospitalCompleted
-
University of PennsylvaniaChildren's Hospital of Philadelphia; National Institute of Nursing Research...CompletedAdolescent | Attention | Accidents, Traffic | Motor VehiclesUnited States
-
Rhode Island HospitalUniversity of ChicagoCompleted
-
Pacific Institute for Research and EvaluationNational Institute of Mental Health (NIMH)Completed
-
Rhode Island HospitalCompleted
-
Emory UniversityCenters for Disease Control and PreventionCompleted
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell NeoplasmUnited States