Trauma-Informed Toolkit for HIV Prevention in African American Women

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Trauma-Informed Toolkit for HIV Prevention in African American Women?

Research shows that trauma-informed care (TIC) can help people with HIV by reducing triggers of past trauma and promoting patient empowerment, which can improve their engagement and retention in healthcare. This approach is particularly important for those who have experienced interpersonal violence, as it can help prevent re-traumatization and improve overall health outcomes. ^{1 2 3 4 5}

Is the Trauma-Informed Toolkit for HIV Prevention in African American Women safe for humans?

The Trauma-Informed Toolkit, which includes trauma-informed care approaches, has been used in various settings to address trauma among people with HIV and other conditions. While specific safety data for this toolkit is not detailed, trauma-informed care is generally considered safe and beneficial for improving health outcomes in diverse populations. ^{2 6 7 8 9}

How is the Trauma-Informed Toolkit treatment for HIV prevention in African American women different from other treatments?

The Trauma-Informed Toolkit is unique because it specifically addresses the impact of trauma on HIV prevention, focusing on the socio-cultural and gender-specific needs of African American women. Unlike other treatments, it integrates trauma-informed care to improve the effectiveness of HIV services by considering the pervasive impact of trauma and gender-based violence on HIV outcomes. ^{2 6 10 11 12}

What is the purpose of this trial?

Pre-exposure prophylaxis may be a viable option for African American women at-risk for HIV infection, but few studies have identified optimal strategies to reach African American women in need of Pre-Exposure Prophylaxis nor examined effective strategies to scale-up Pre-Exposure Prophylaxis among African American women in the South. African American women in the South experience high rates of intimate partner violence which could force women to choose between HIV prevention or intimate partner violence prevention. The proposed research study seeks to develop, pilot-test, and evaluate a Pre-Exposure Prophylaxis Implementation Toolkit within two community healthcare clinics located in Jackson, Mississippi to increase Pre-Exposure Prophylaxis uptake among African American, address intimate partner violence as a barrier to Pre-Exposure Prophylaxis uptake, and ultimately combat racial disparities in women's HIV diagnoses.

Research Team

Tiara C. Willie, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

This trial is for African American women receiving care at community healthcare clinics in Mississippi, who are at risk for HIV infection and may also be dealing with intimate partner violence. Participants must speak and understand English.

Inclusion Criteria

Currently providing care at a community healthcare clinic in Mississippi

Exclusion Criteria

Inability to read and comprehend questions

Timeline

Formative Evaluation

Key informant interviews with clinical staff and focus groups with African American women to inform the development of the Pre-Exposure Prophylaxis Implementation Toolkit

Not specified

Toolkit Development and Pilot Testing

Development of the Pre-Exposure Prophylaxis Implementation Toolkit and pilot testing in two community healthcare clinics using a nonrandomized waitlist control design

8 months

Effectiveness Stage

Assessment of changes in Pre-Exposure Prophylaxis uptake and retention in care at the clinic level from 8-months before and after the Toolkit is implemented

8 months

Adoption Stage

Focus groups with clinical staff to assess barriers and facilitators to the Toolkit's adoption

Not specified

Follow-up

Participants are monitored for retention in care and effectiveness of the Toolkit implementation

6 months

Treatment Details

Interventions

• Trauma-Informed Toolkit

Trial Overview The study is testing a Trauma-Informed Toolkit designed to increase the use of Pre-Exposure Prophylaxis (PrEP) among African American women. It aims to address both HIV prevention and intimate partner violence within two clinics in Jackson, Mississippi.

Participant Groups

Group I: Trauma-Informed Pre-Exposure Prophylaxis Implementation Toolkit Experimental Treatment 1 Intervention

The Toolkit to be developed in the proposed study includes components from the women-specific Pre-Exposure Prophylaxis care continuum theoretical model and implementation challenges, and is adapted to identify and provide care to women experiencing intimate partner violence. Overall, the Toolkit is designed to create culturally-congruent, intimate partner violence-informed clinical settings; and equip clinical staff with the knowledge and skills they need to address HIV prevention for African American women; and integrate intimate partner violence into Pre-Exposure Prophylaxis care services.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Findings from Research

The LinkPositively intervention, designed specifically for Black women living with HIV who have experienced interpersonal violence, aims to improve engagement in HIV care through technology-based support, including peer navigation and a mobile app.

Preliminary results from the ongoing pilot trial involving 80 participants will assess the feasibility and acceptability of this intervention, with the potential to enhance HIV care outcomes if proven effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Trauma-Informed HIV Intervention (LinkPositively) to Improve HIV Care Among Black Women Affected by Interpersonal Violence: Protocol for a Pilot Randomized Controlled Trial. Stockman, JK., Anderson, KM., Fernandez DeSoto, A., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of trauma-informed care and trauma-responsive services in clinical settings: a latent class regression analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Interventions for addressing trauma among people with HIV: a narrative review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Support for Trauma-informed Care Implementation Among Ryan White HIV Clinics in the Southeastern United States. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Gathering Trauma Narratives: A Qualitative Study on the Impact of Self-Identified Traumas on People Living with HIV (PLWH). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Application of the Consolidated Framework for Implementation Research to Facilitate Delivery of Trauma-Informed HIV Care. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Trauma-Informed HIV Prevention and Treatment. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Using systems-mapping to address Adverse Childhood Experiences (ACEs) and trauma: A qualitative study of stakeholder experiences. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Creating a Communitywide System of Trauma-Informed Care. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Trauma informed interventions: A systematic review. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

A Trauma-Informed HIV Intervention (LinkPositively) to Improve HIV Care Among Black Women Affected by Interpersonal Violence: Protocol for a Pilot Randomized Controlled Trial. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Adapting an Evidence-Based HIV-Prevention Intervention for Women in Domestic Violence Shelters. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a socio-cultural intervention to reduce unprotected sex for HIV among African American/Black women. [2022]