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

Trial Summary

What is the purpose of this trial?

The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. The intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to PrEP care. The purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. The hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater PrEP uptake and adherence.

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 data supports the effectiveness of the treatment Integrated Intervention to Promote PrEP Uptake for women with trauma-related conditions?

Research shows that using strengths-based case management and navigation services can help people start and stick with PrEP, a medication to prevent HIV. These approaches have been effective in helping people overcome barriers to accessing PrEP, suggesting they could also support women with trauma-related conditions in using PrEP. ^{1 2 3 4 5}

Is the PrEP Adherence Program for Women with Trauma-Related Conditions safe for humans?

The safety of PrEP (pre-exposure prophylaxis) for HIV prevention has been studied, and it is generally considered safe for use in women. However, the specific program you mentioned, which includes an adherence component for women with trauma-related conditions, does not have specific safety data available in the provided research articles. ^{1 6 7 8 9}

How is the Integrated Intervention to Promote PrEP Uptake treatment different from other treatments for women with trauma-related conditions?

The Integrated Intervention to Promote PrEP Uptake is unique because it combines strategies to help women with trauma-related conditions start and stick with PrEP (a medication to prevent HIV) by addressing barriers like stigma and lack of support, and by teaching skills for disclosure and securing support from significant others. ^{1 2 5 6 10}

Research Team

Angela Heads, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2020]

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

PrEParing Women to Prevent HIV: An Integrated Theoretical Framework to PrEP Black Women in the United States. [2023]

3. Switzerland 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. [2023]

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

Integrated Pharmacy and PrEP Navigation Services to Support PrEP Uptake: A Quality Improvement Project. [2020]

5. United States 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. [2022]

6. United States 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). [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Perspectives of US women participating in a candidate PrEP study: adherence, acceptability and future use intentions. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis for HIV prevention in women: current perspectives. [2020]

9. United States 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. [2023]

10. United States 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. [2023]