HIVFemAALESNCT02189876
Females of African American Legacy Empowering Self (FemAALES)
A study testing FemAALES in people with HIV, run by Charles Drew University of Medicine and Science at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- FemAALES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female sex
- self-identifies as Black/African American
- 18 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
Who cannot join
- 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,
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. John's Well Child and Family Center
Los Angeles, California, 90037
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Official title: Reducing HIV/STD Risk in African American Women With At-Risk Male Partners
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.
Read the detailed description
Two thirds of female HIV/AIDS cases occur in Black women and an estimated 76% of these are attributed to heterosexual contact. HIV is the third-leading killer of Black women ages 25-44, and STI associated morbidity may contribute to racial disparities in cervical cancer, adverse pregnancy outcomes, and infant mortality.
The investigators propose to test the efficacy of the FemAALES of African American Legacy Empowering Self Intervention in a population of adult Black/African American women who have either no health insurance or a public/subsidized form of health insurance against a Control or "Standard of Care" arm involving family planning and STI counseling.
In addition, the investigators will explore the impact of the FemAALES intervention on the use of new media for social support and networking, obtaining health information, and identifying resources and services. FemAALES incorporates cultural contextual, and partnership issues and promotes access to resources not readily available to this population. FemAALES curriculum is guided by the Theory of Reasoned Action and Planning and Critical Thinking and Cultural Affirmation Model developed by a collaborating community-based organization.
The primary specific aims are to:
- Determine the impact of the FemAALES of African American Legacy Empowering Self (FemAALES II) on HIV risk factors including:
- number of sex partners
- unprotected anal/vaginal sex
- incidence of bacterial STIs
- Determine the impact of the FemAALES interventions on psychosocial outcomes, including self-efficacy for safer sex negotiation and discussions with partners regarding HIV/STI testing and risk
- Hypothesis 1: Compared to the control, FemAALES will reduce the number of vaginal/anal sex partners and number of episodes of unprotected intercourse at 3months and 9 months post intervention
- Hypothesis 2: Compared to the control, FemAALES will reduce the incidence of gonorrhea and chlamydia
- Hypothesis 3: Compared to the control, FemAALES will improve self-efficacy for condom negotiation
- Hypothesis 4: Compared to the control. FemAALES will increase the proportion of women who have discussions regarding sexual and drug use risk factors with their sexual partners.
A third, exploratory aim, is to assess the impact of the FemAALES intervention on the use of new social media for social support and networking, obtaining health information and identifying resources and services.
- Conditions
- HIV
- Being tested
- Standard of Care, FemAALES
- Keywords
- HIV Prevention, Behavioral Intervention, Condom Use, African American, Sexually Transmitted Disease, Sexually Transmitted Infection, Internet
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
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.
FemAALESBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FemAALES | Experimental | Females of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention. Receives: Behavioral: Standard of Care; Behavioral: FemAALES |
| Standard of Care | Active comparator | A one-time STD/family planning testing and counseling session provided to all study participants. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: 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.
Measured: 9 months
Secondary outcomes (1)
Change in Safer Sex Negotiation Skills and Behaviors
Determine the impact of the FemAALES conditions compared to the control condition on psychosocial outcomes, including self-efficacy for safer sex negotiation and discussions regarding HIV/STI risk with sexual partners.
Measured: 3 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2013
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of California, Los Angeles, St. John's Well Child & Family Center
- Responsible party
- Sponsor
- Investigators
- Nina T Harawa, Ph.D, MPH, Principal investigator, Charles Drew UniversityMartin Shapiro, MD Ph.D MPH, Principal investigator, University of California, Los AngelesSamuel Gonzalez, MS, Principal investigator, St. John's Well Child and Family Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189876
- Sponsor's protocol ID
- MD-13-010
- Other IDs
- P20MD000182
- Acronym
- FemAALES
- Status last verified
- Aug 2018
- First submitted
- 11 Jun 2014
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36520613
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV/STD Risk in African American Women With At-Risk Male Partners
- ClinicalTrials.gov ID
- NCT02189876
- Acronym / sponsor ID
- FemAALES / MD-13-010
- Conditions
- HIV
- Keywords
- HIV Prevention, Behavioral Intervention, Condom Use, African American, Sexually Transmitted Disease, Sexually Transmitted Infection, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of California, Los Angeles, St. John's Well Child & Family Center
- Study start
- Jul 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Two thirds of female HIV/AIDS cases occur in Black women and an estimated 76% of these are attributed to heterosexual contact. HIV is the third-leading killer of Black women ages 25-44, and STI associated morbidity may contribute to racial disparities in cervical cancer, adverse pregnancy outcomes, and infant mortality.
The investigators propose to test the efficacy of the FemAALES of African American Legacy Empowering Self Intervention in a population of adult Black/African American women who have either no health insurance or a public/subsidized form of health insurance against a Control or "Standard of Care" arm involving family planning and STI counseling.
In addition, the investigators will explore the impact of the FemAALES intervention on the use of new media for social support and networking, obtaining health information, and identifying resources and services. FemAALES incorporates cultural contextual, and partnership issues and promotes access to resources not readily available to this population. FemAALES curriculum is guided by the Theory of Reasoned Action and Planning and Critical Thinking and Cultural Affirmation Model developed by a collaborating community-based organization.
The primary specific aims are to:
- Determine the impact of the FemAALES of African American Legacy Empowering Self (FemAALES II) on HIV risk factors including:
- number of sex partners
- unprotected anal/vaginal sex
- incidence of bacterial STIs
- Determine the impact of the FemAALES interventions on psychosocial outcomes, including self-efficacy for safer sex negotiation and discussions with partners regarding HIV/STI testing and risk
- Hypothesis 1: Compared to the control, FemAALES will reduce the number of vaginal/anal sex partners and number of episodes of unprotected intercourse at 3months and 9 months post intervention
- Hypothesis 2: Compared to the control, FemAALES will reduce the incidence of gonorrhea and chlamydia
- Hypothesis 3: Compared to the control, FemAALES will improve self-efficacy for condom negotiation
- Hypothesis 4: Compared to the control. FemAALES will increase the proportion of women who have discussions regarding sexual and drug use risk factors with their sexual partners.
A third, exploratory aim, is to assess the impact of the FemAALES intervention on the use of new social media for social support and networking, obtaining health information and identifying resources and services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FemAALES | Experimental | Behavioral: Standard of Care, Behavioral: FemAALESFemales of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention. |
| Standard of Care | Active comparator | Behavioral: Standard of CareA one-time STD/family planning testing and counseling session provided to all study participants. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- female sex
- self-identifies as Black/African American
- 18 years of age or older
- English speaking
- has had unprotected vaginal or anal sex in the last 90 days
Key exclusion criteria (1 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareAll 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. | Behavioural | FemAALES, Standard of Care |
| FemAALESWomen 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. | Behavioural | FemAALES |
Primary outcome
Change in number of sex partners from baseline
Time frame: 3 and 9 months
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 .
Change in frequency of unprotected sex from baseline.
Time frame: 3 and 9 months
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.
Change in bacterial STDs from baseline
Time frame: 9 months
Examine the impact of the FemAALES interventions compared to the control condition on the incidence of gonorrhea and chlamydia.
1 secondary outcome
Change in Safer Sex Negotiation Skills and Behaviors
Time frame: 3 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Derived from this study: PubMed 36520613Adeyeba 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina T Harawa, Ph.D, MPH principal investigator
Charles Drew University
Martin Shapiro, MD Ph.D MPH principal investigator
University of California, Los Angeles
Samuel Gonzalez, MS principal investigator
St. John's Well Child and Family Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemAALES in people with HIV, run by Charles Drew University of Medicine and Science at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of sex partners from baseline (time frame: 3 and 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02189876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.