Females of African American Legacy Empowering Self (FemAALES)

NCT02189876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2018-08-03

No results posted yet for this study

Summary

The FemAALES Project is a community collaborative two-arm intervention designed to prevent HIV (human immunodeficiency) and STD (sexually transmitted disease) infection and transmission among African American women and men by reducing sexual risk factors and enhancing sexual negotiation skills. The team of investigators is a collaboration of researchers and community service providers who are committed to developing prevention interventions that employ holistic and culturally relevant approaches. This includes recognizing the impact of forces such as racism, sexism, and gender expectations on individual behavior and relationship dynamics in African American communities. Specifically, the investigators hypothesis is that compared to the control condition the FemAALES intervention arm will reduce risky sexual behavior and STI (sexually transmitted infection) incidence and will increase condom self-efficacy and risk behavior communication with sexual partners.

Conditions

Interventions

BEHAVIORAL

Standard of Care

All participants will be provided a STD/HIV pre-test counseling session. This session will be provided by either certified project staff or clinical staff at a Los Angeles clinic that conduct State of CA Fam Pact services for patients who are of child bearing age, including our current study partner St. John's Well Child and Family Center and our former study partner, JWCH (John Wesley Community Health) Institute-Wesley Health Center Clinics. Following the counseling session, the participant will be asked to provide a sample of urine to test for Chlamydia and Gonorrhea.

BEHAVIORAL

FemAALES

Women will attend 9 small group sessions over 4 weeks. Three of these sessions will focus specifically on participants learning to use a computer, set up an email account, communicate with the team and the group using the Internet, and developing a prevention message for display on project website and social media accounts. The other 6 sessions will include discussions on the following topics: being a Black woman in American, Black history, assessing personal health, changing current behaviors, HIV/AIDS information, and education, self-empowerment, communication skills, reasons to change, and goal setting.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • University of California, Los Angeles

    collaborator OTHER
  • St. John's Well Child & Family Center

    collaborator UNKNOWN
  • Charles Drew University of Medicine and Science

    lead OTHER

Principal Investigators

  • Nina T Harawa, Ph.D, MPH · Charles Drew University

  • Martin Shapiro, MD Ph.D MPH · University of California, Los Angeles

  • Samuel Gonzalez, MS · St. John's Well Child and Family Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02189876 on ClinicalTrials.gov