Females of African American Legacy Empowering Self (FemAALES)
FemAALES
Reducing HIV/STD Risk in African American Women With At-Risk Male Partners
2 other identifiers
interventional
256
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Jul 2013
Longer than P75 for not_applicable hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedAugust 3, 2018
August 1, 2018
4.8 years
June 11, 2014
August 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in number of sex partners from baseline
Determine the impact of the FemAALES intervention compared to the control condition on the number of vaginal and anal sex partners in the prior 90 days .
3 and 9 months
Change in frequency of unprotected sex from baseline.
Determine the impact of the FemAALES interventions compared to the control condition on the number of vaginal or anal sex acts reported without condoms in the prior 90 days.
3 and 9 months
Change in bacterial STDs from baseline
Examine the impact of the FemAALES interventions compared to the control condition on the incidence of gonorrhea and chlamydia.
9 months
Secondary Outcomes (1)
Change in Safer Sex Negotiation Skills and Behaviors
3 and 9 months
Other Outcomes (1)
Intervention Effect on Use of New Media
9 months
Study Arms (2)
FemAALES
EXPERIMENTALFemales of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention.
Standard of Care
ACTIVE COMPARATORA one-time STD/family planning testing and counseling session provided to all study participants.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- female sex
- self-identifies as Black/African American
- years of age or older
- English speaking
- has had unprotected vaginal or anal sex in the last 90 days
- any male partner in the last 90 days has done one or more of the following: had sex with a man; had sex with a male-to-female transgender; used crack cocaine, heroin, or methamphetamines; been incarcerated for more than 6 months; had sex with other female partners during the relationship; OR - a male partner in the last 90 days has an unknown sexual history
- publicly funded or public subsidized health insurance
You may not qualify if:
- participated in a small group HIV prevention program in the past 12 months, participated in HARRP program in the past 12 months, has private insurance, refuses chlamydia or gonorrhea test at baseline,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St. John's Well Child and Family Center
Los Angeles, California, 90037, United States
Charles Drew University of Medicine and Science
Los Angeles, California, 90059, United States
Related Publications (1)
Adeyeba MO, Montazeri Q, Bivens-Davis T, Schrode KM, Harawa NT. Reducing Human Immunodeficiency Virus and Sexually Transmitted Infections Risk in African American Women with At-Risk Male Partners: A Randomized Trial. J Womens Health (Larchmt). 2023 Mar;32(3):311-322. doi: 10.1089/jwh.2022.0194. Epub 2022 Dec 14.
PMID: 36520613DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina T Harawa, Ph.D, MPH
Charles Drew University
- PRINCIPAL INVESTIGATOR
Martin Shapiro, MD Ph.D MPH
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Samuel Gonzalez, MS
St. John's Well Child and Family Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2014
First Posted
July 15, 2014
Study Start
July 1, 2013
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
August 3, 2018
Record last verified: 2018-08