PrEP Adherence Program for Women with Trauma-Related Conditions

Overseen By Kaixuan An

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: HIV positive, Severe cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to help women adhere to their PrEP medication, which can prevent HIV. It targets women dealing with trauma-related mental health issues who are not currently using PrEP. The trial aims to determine if this new approach, called the Integrated Intervention to Promote PrEP Uptake, is more effective than standard treatment in encouraging PrEP use. Suitable participants include women in mental health treatment, those who have experienced trauma, and those who are sexually active with a male partner. Participants must also be HIV-negative and have access to a smartphone.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve PrEP adherence for women facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mental health treatment and PrEP adherence, so it's best to discuss your specific medications with the study team.

What prior data suggests that this intervention is safe for promoting PrEP uptake in women with trauma-related conditions?

Research has shown that the combined approach to initiating and maintaining PrEP (pre-exposure prophylaxis) is designed to be safe. Although specific safety data for this approach is limited, PrEP itself is generally well-tolerated. Past studies have found that methods to support adherence to PrEP do not pose significant safety concerns. These methods often involve education and motivation, which are non-invasive and carry minimal risk.

In other studies, incorporating safety planning into a trauma-informed PrEP approach has helped women adhere to their PrEP routine safely. This suggests that the approach should not introduce new safety issues. Overall, the goal is to enable women to take PrEP safely and effectively without adding extra risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Intervention to Promote PrEP Uptake because it offers a tailored approach to help women with trauma-related conditions adhere to PrEP, a preventive treatment for HIV. Unlike traditional methods that focus solely on medication adherence, this intervention integrates support for mental health and trauma, addressing the root challenges that may affect PrEP use in this group. By combining psychological support with PrEP education, this approach has the potential to significantly improve adherence rates and overall health outcomes for these women, offering a more holistic solution than standard care.

What evidence suggests that this intervention is effective for promoting PrEP uptake in women with trauma-related conditions?

Research shows that combining mental health support and education can help cisgender women with trauma-related issues start and consistently use PrEP (pre-exposure prophylaxis) more effectively. In this trial, participants in the "Integrated Intervention to Promote PrEP Uptake" arm will receive mental health care, education, and skills training. This approach has improved adherence to PrEP routines. In early tests, women who received this combined support were more likely to begin and continue using PrEP than those in the "Standard Treatment Condition" arm, who received regular care. This suggests that the integrated intervention could be a promising way to help women at higher risk for HIV protect themselves consistently. The goal is to make using PrEP easier and more manageable for women dealing with trauma-related mental health challenges. ^{1 2 3 6 7}

Who Is on the Research Team?

Angela Heads, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for cisgender women receiving treatment for trauma-related mental health conditions who are at increased risk of HIV. Participants should be interested in a program to help them start and stick with PrEP, a medication that prevents HIV. Details on specific inclusion or exclusion criteria were not provided.

Inclusion Criteria

Eligible for PrEP based on having at least one Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP

I have been sexually active with someone of the opposite sex in the last 6 months.

I am not using HIV prevention medication.

Exclusion Criteria

I cannot or do not want to follow the study's requirements.

HIV positive

Concurrently participating in another HIV prevention program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an integrated bio-behavioral intervention to promote PrEP uptake and adherence

12 weeks

Weekly questionnaires and video uploads

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Extension

Participants may continue to be monitored for long-term adherence and outcomes

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Intervention to Promote PrEP Uptake

Trial Overview The study tests an integrated intervention designed to encourage starting and maintaining use of PrEP within the context of mental health care for trauma. It will be compared with standard treatments to see if it's more effective, feasible, and acceptable.

How Is the Trial Designed?

Group I: Integrated Intervention to Promote PrEP Uptake Experimental Treatment 1 Intervention

Group II: Standard Treatment Condition Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The POWER Up study aims to improve the uptake and persistence of HIV pre-exposure prophylaxis (PrEP) among Black women in the Midwest and South by implementing five targeted strategies that address barriers at the provider, patient, and clinic levels.

Using a stepped-wedge cluster randomized trial, the study will evaluate the effectiveness of these strategies, which include patient education, provider training, and PrEP navigation, to ultimately enhance PrEP service delivery and reduce HIV transmission among this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

POWER Up-Improving pre-exposure prophylaxis (PrEP) uptake among Black cisgender women in the Southern United States: Protocol for a stepped-wedge cluster randomized trial (SW-CRT). Ridgway, JP., Devlin, SA., Friedman, EE., et al.[2023]

Preexposure prophylaxis (PrEP) has proven effective in significantly reducing HIV incidence among women, particularly benefiting Black women who represent over half of new HIV cases in this demographic.

Despite its efficacy, PrEP uptake among women in the U.S. remains low, highlighting the need for further research to identify and address the multilevel barriers affecting awareness and implementation of PrEP in Black women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrEParing Women to Prevent HIV: An Integrated Theoretical Framework to PrEP Black Women in the United States. Chapman Lambert, C., Marrazzo, J., Amico, KR., et al.[2023]

The implementation of an evidence-based PrEP Navigation tool at a community health center significantly reduced the time from initial prescription to medication pickup by an average of 1.42 days, indicating improved access to PrEP for patients.

This quality improvement project involved 198 patients and highlights the importance of addressing patient-reported barriers to enhance medication adherence and support the uptake of PrEP in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Pharmacy and PrEP Navigation Services to Support PrEP Uptake: A Quality Improvement Project. Coleman, M., Hodges, A., Henn, S., et al.[2020]

A study involving 130 women showed that while most reported good adherence to PrEP, some admitted to over-reporting, indicating a need for better adherence support and education.

Many women expressed intentions not to use PrEP in the future due to perceived low personal risk and concerns about affordability, rather than side effects, highlighting the importance of addressing these barriers to improve PrEP uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of US women participating in a candidate PrEP study: adherence, acceptability and future use intentions. Amico, KR., Ramirez, C., Caplan, MR., et al.[2023]

In a pilot study involving 61 adults interested in PrEP, those receiving strengths-based case management (SBCM) showed a higher rate of completing a provider visit (53.3%) compared to the control group (32.3%), suggesting that SBCM can effectively facilitate access to PrEP care.

Overall, 34% of participants initiated PrEP within 12 weeks, with no significant difference in the time to initiation between the SBCM and control groups, indicating that while SBCM helps with provider visits, it may not speed up the actual start of PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Study of Passive versus Active PrEP Patient Navigation for a Heterogeneous Population at Risk for HIV in South Florida. Doblecki-Lewis, S., Butts, S., Botero, V., et al.[2020]

A study involving 25 postpartum women who adhered to PrEP (pre-exposure prophylaxis) revealed that strong HIV risk perception and the desire to have an HIV-free baby were key motivators for consistent use.

Support from partners and family, along with effective communication about PrEP, significantly enhanced adherence, while stigma and side effects were common barriers that could be managed with education and strategic planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I had Made the Decision, and No One was Going to Stop Me" -Facilitators of PrEP Adherence During Pregnancy and Postpartum in Cape Town, South Africa. Joseph Davey, DL., Knight, L., Markt-Maloney, J., et al.[2022]

Oral HIV pre-exposure prophylaxis (PrEP) has been shown to effectively reduce HIV incidence among women who adhere to the treatment, but awareness and uptake remain low, particularly among women from racial and ethnic minority communities.

Innovative strategies, including the development of topical formulations and long-acting injectable PrEP, along with community-oriented approaches, are essential to improve access and adherence to PrEP, potentially making a significant impact on the HIV epidemic among women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis for HIV prevention in women: current perspectives. Flash, CA., Dale, SK., Krakower, DS.[2020]

A study involving 603 adolescent girls and young women in South Africa identified that external factors like school schedules and social conflicts, such as partner mistrust, significantly contribute to breaks in daily oral PrEP use.

Social support and familiarity with PrEP were crucial for re-initiating use, suggesting that long-acting injectable PrEP could help overcome barriers to consistent adherence and improve overall prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa. de Vos, L., Mudzingwa, EK., Fynn, L., et al.[2023]

In a pilot study involving 83 PrEP-eligible cisgender women, the Just4Us intervention significantly increased PrEP knowledge but did not lead to a notable difference in actual PrEP prescriptions compared to a brief information session, with only 13% receiving a prescription after 3 months.

Despite high interest in PrEP, the study identified numerous personal and structural barriers that hindered uptake, indicating that while Just4Us shows promise, further research is needed to address these challenges effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Pilot Study of Just4Us, a Counseling and Navigation Intervention to Promote Oral HIV Prophylaxis Uptake Among PrEP-Eligible Cisgender Women. Teitelman, AM., Tieu, HV., Chittamuru, D., et al.[2023]

A qualitative study involving 16 women in substance use treatment revealed that while all participants were willing to use PrEP for HIV prevention, their motivation was closely tied to their perceived risk, which fluctuated based on their substance use and engagement in transactional sex.

Barriers to PrEP use included concerns about how substance use might interfere with adherence, fear of stigma, and doubts about daily commitment, highlighting the need for tailored messaging and support from healthcare providers to improve PrEP uptake in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Study of Barriers and Facilitators of PrEP Uptake Among Women in Substance Use Treatment and Syringe Service Programs. Tross, S., Spector, AY., Ertl, MM., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/search/FKYEH9S8IUyyf4fkTRSwdA/project-details/10649451

Development and Pilot Testing of a Mental Health ... - NIH RePORTER Development and Pilot Testing of a Mental Health Clinic-Based PrEP Uptake and Adherence Intervention for Women in Treatment for Trauma-Related Conditions.

2. trialx.com trialx.com/clinical-trials/listings/322131/pre-exposure-prophylaxis-prep-uptake-and-adherence-intervention-for-women-with-trauma-related-conditions/

Pre-exposure Prophylaxis (PrEP) Uptake and Adherence ... The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women ...

3. withpower.com withpower.com/trial/phase-substance-use-8-2024-e7f4f

PrEP Adherence Program for Women with Trauma-Related ... The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02852226

NCT02852226 | CRUSH-PrEP for Women Project Specifically, the CRUSH PrEP for Women Project is a 16month demonstration project designed to evaluate and assess the adherence of PrEP within a community based ...

5. reporter.nih.gov reporter.nih.gov/project-details/9537674

Developing a Women-Focused PrEP Intervention for HIV ... Alarmingly, there are currently no interventions in the US to promote PrEP uptake among women. The long term goal is to develop effective approaches to support ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2211335523003819

Perspectives on HIV pre-exposure prophylaxis (PrEP) ... The current study sought to identify key components to develop a trauma-informed PrEP implementation program for Black cisgender women and clinical staff.

7. whijournal.com whijournal.com/article/S1049-3867(21)00055-4/fulltext

Integrating Trauma-Informed Policy and Pre-exposure ... Furthermore, safety planning can improve women's safety while adhering to PrEP and attending subsequent medical appointments. Safety ...