Clinical trial NCT01553682: Project N-Liten- HIV Prevention for African American Women
Official title: Reducing Alcohol-Related HIV Risk in African American Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Keywords: HIV
STDs
African American Females
Alcohol
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 560
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: Incident STD infection confirmed by laboratory PRC testing over a 12-month follow-up.
timeFrame: 12 months post-randomization
Secondary outcomes:
measure: Proportion of condom-protected vaginal or anal sex acts over a 12-month follow-up.
timeFrame: 12 months post-randomization
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Ralph J DiClemente, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Georgia
name: Jennifer L. Monahan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DiClemente RJ, Rosenbaum JE, Rose ES, Sales JM, Brown JL, Renfro TL, Bradley ELP, Davis TL, Capasso A, Wingood GM, Liu Y, West SG, Hardin JW, Bryan AD, Feldstein Ewing SW. Horizons and Group Motivational Enhancement Therapy: HIV Prevention for Alcohol-Using Young Black Women, a Randomized Experiment. Am J Prev Med. 2021 May;60(5):629-638. doi: 10.1016/j.amepre.2020.11.014. Epub 2021 Mar 5.