Project N-Liten- HIV Prevention for African American Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ralph J. DiClemente, Emory University
ClinicalTrials.gov Identifier:
NCT01553682
First received: March 5, 2012
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Sexually Transmitted Diseases
Behavioral: Horizons+General Health Promotion (GHP)
Behavioral: Horizons+Motivational Enhancement Therapy (GMET)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing Alcohol-Related HIV Risk in African American Females

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Incident STD infection confirmed by laboratory PRC testing over a 12-month follow-up. [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
    Incident STD infection confirmed by laboratory PRC testing.


Secondary Outcome Measures:
  • Proportion of condom-protected vaginal or anal sex acts over a 12-month follow-up. [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
    Assessed by ACASI


Enrollment: 560
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: 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.
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.
Behavioral: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553682

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Ralph J DiClemente, PhD Emory University
Principal Investigator: Jennifer L. Monahan, PhD University of Georgia
  More Information

No publications provided

Responsible Party: Ralph J. DiClemente, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01553682     History of Changes
Other Study ID Numbers: IRB00048502, 5R01AA018096
Study First Received: March 5, 2012
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
HIV
STDs
African American Females
Alcohol

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 09, 2014