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

March 5, 2012
June 12, 2014
December 2011
June 2015   (final data collection date for primary outcome measure)
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.
Incident Chlamyida and gonorrhea (CT/GC) infection confirmed by laboratory PRC testing over a 12-month follow-up. [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
Incident Chlamyida and gonorrhea (CT/GC) infection confirmed by laboratory PRC testing.
Complete list of historical versions of study NCT01553682 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Project N-Liten- HIV Prevention for African American Women
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Sexually Transmitted Diseases
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Horizons+General Health Promotion (GHP)
  • 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.
    Intervention: Behavioral: Horizons+Motivational Enhancement Therapy (GMET)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
560
December 2015
June 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01553682
IRB00048502, 5R01AA018096
No
Ralph J. DiClemente, Emory University
Emory University
Not Provided
Principal Investigator: Ralph J DiClemente, PhD Emory University
Principal Investigator: Jennifer L. Monahan, PhD University of Georgia
Emory University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP