PrEP Adherence Intervention for Substance Use Disorders

Overseen By Kaixuan An

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Other SUD treatment, Cognitive impairment, Psychological distress, PrEP ineligibility, others

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

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help women with substance use disorders consistently use PrEP, a medication that prevents HIV. It focuses on women with high-risk sexual behaviors who are not currently using PrEP. Participants will have PrEP prescribed by a nurse practitioner and receive support through counseling sessions. Women who are Black/African American or Hispanic/Latina, have a substance use disorder, are HIV negative, sexually active, and not currently using PrEP might be suitable for this trial. Researchers aim to determine if this approach is more effective than usual care in increasing PrEP use and adherence. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve health outcomes for women at risk.

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 might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this intervention is safe for increasing PrEP adherence?

Research has shown that addiction clinics are developing new support programs to assist women with substance use disorders who are at high risk of HIV. These programs aim to help them take PrEP (pre-exposure prophylaxis) regularly, which can prevent HIV.

There is no specific safety data for the support program itself, as it is not a medication but a method to assist individuals. However, PrEP, the medication used, has been well-studied and is generally safe. Large studies found that most people did not experience serious side effects. Some reported mild issues like nausea or headaches, but these were uncommon.

The trial focuses on how this support can help women use PrEP effectively, rather than testing a new drug's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Addiction Clinic-Based PrEP Adherence Intervention because it offers a new approach to helping women with substance use disorders stick to their PrEP (pre-exposure prophylaxis) regimen. Unlike standard care options, which typically involve routine counseling and medication management, this intervention is specifically designed to address the unique challenges faced by women with substance use disorders. By focusing on personalized support and integrating addiction treatment with PrEP adherence strategies, this method aims to improve health outcomes and reduce the risk of HIV transmission in this vulnerable population.

What evidence suggests that this intervention is effective for increasing PrEP uptake and adherence?

This trial will compare an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders to standard care treatment. Research has shown that programs in addiction clinics can significantly increase the number of women with substance use issues who start and continue using PrEP, a medication that helps prevent HIV. Early results suggest that when women receive PrEP information during counseling and get extra support from healthcare providers, they are more likely to use PrEP consistently. Studies have found that women who receive personalized help are more likely to begin and maintain PrEP use. This method aims to help women make informed decisions about using PrEP to prevent HIV, especially those at higher risk. While more research is needed, early signs are promising for boosting PrEP use in this group. ^{1 2 3 5 6}

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 Black/African American and Hispanic/Latina cisgender women with substance use disorders, who are HIV negative, sexually active, not currently using PrEP, speak English, and have smartphone access. It's not for those in other SUD programs, unable to consent or participate fully due to cognitive or psychological issues, ineligible for PrEP by CDC criteria or with medical contraindications.

Inclusion Criteria

I am not using HIV prevention medication.

Able to speak, read, and write in English

I am a Black/African American or Hispanic/Latina cisgender woman.

Exclusion Criteria

I am able to understand and consent to participate in the study.

Ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk

I cannot take PrEP due to kidney problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for PrEP uptake and adherence, including filling the PrEP prescription and taking at least one dose of the medication

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders

Trial Overview The study tests a behavioral intervention aimed at increasing uptake and adherence to PrEP among women with high-risk sexual behaviors and problematic substance use. The intervention includes counseling sessions on PrEP information, prevention navigation services, and prescription of PrEP within an addiction treatment setting.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Group II: Standard of care treatment 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+

Published Research Related to This Trial

The patient-centered decision aid (DA) for PrEP significantly increased interest in PrEP among women in addiction treatment, with interest rising from 25% to 89% for those who chose to use the DA.

Women using the DA were more likely to see a healthcare provider for PrEP compared to those receiving enhanced standard of care, indicating that the DA effectively engaged participants in the HIV prevention process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders. Meyer, J., Price, C., Tracey, D., et al.[2022]

Women with substance use disorders (SUDs) often lack awareness of their HIV risk and the availability of pre-exposure prophylaxis (PrEP), which contributes to low uptake of this effective prevention method.

Motivation to engage in HIV prevention among these women is influenced by competing life priorities, a minimization of perceived risk, and anticipated stigma, highlighting the need for targeted interventions that make PrEP more relevant and accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's Decision-Making about PrEP for HIV Prevention in Drug Treatment Contexts. Qin, Y., Price, C., Rutledge, R., et al.[2022]

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]

The study aims to evaluate the effectiveness of a new bio-behavioral intervention called the Community-friendly Health Recovery Program (CHRP-BB) in improving PrEP adherence and reducing HIV risk among opioid-dependent people who use drugs (PWUD) enrolled in a methadone maintenance program, using a randomized controlled trial design.

This research will assess participants at multiple time points over 44 weeks, focusing on both biomedical outcomes (like PrEP adherence) and behavioral changes (such as drug and sex-related HIV risk behaviors), making it one of the first trials to integrate these approaches for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of an integrated bio-behavioral approach to improve adherence to pre-exposure prophylaxis and HIV risk reduction among opioid-dependent people who use drugs: The CHRP-BB study. Shrestha, R., Altice, FL., Sibilio, B., et al.[2020]

A study involving 20 women with opioid use disorder (OUD) revealed a strong interest in HIV pre-exposure prophylaxis (PrEP), indicating a potential demand for this preventive treatment among this population.

Despite the high acceptability of the reSET-O mobile app for supporting PrEP and medication-assisted treatment (MAT), only two participants redeemed their prescription, highlighting significant barriers such as access to phones and the internet that hinder implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of a Mobile Phone Application to Support HIV Pre-exposure Prophylaxis Among Women with Opioid Use Disorder. Richterman, A., Ghadimi, F., Teitelman, AM., et al.[2023]

In a study involving 1456 participants across 14 sites in Sub-Saharan Africa, monitoring the fidelity of counseling for the dapivirine vaginal ring was feasible and effective, with 54.1% of expected counseling sessions being audio-recorded.

The majority of reviewed sessions (83.9%) were rated as 'good' or 'fair', indicating that consistent and high-quality counseling can be maintained, which is crucial for supporting adherence to PrEP interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence counseling intervention in a multi-site biomedical HIV prevention study. Balán, IC., Lentz, C., Giguere, R., et al.[2021]

In a study involving 3065 high-risk HIV-negative adults, the incidence of HIV-1 was very low at 1.1 cases per 1000 person-years, showing that both daily and on-demand PrEP are effective in preventing HIV infection.

There was no significant difference in HIV-1 incidence between those using daily PrEP and those using on-demand PrEP, indicating that on-demand PrEP is a valid alternative, providing flexibility for men who have sex with men (MSM) in their HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. Molina, JM., Ghosn, J., Assoumou, L., 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]

Only 2.8% of veterans receiving intensive outpatient (IOP) substance use treatment in the VA were women, highlighting a significant gender disparity in access to treatment.

Women in IOP treatment were younger and had more severe substance use issues and comorbidities compared to their male counterparts, indicating a need for targeted outreach and programming to address the unique needs of women veterans with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of women seeking intensive outpatient substance use treatment in the VA. Stecker, T., Han, X., Curran, GM., et al.[2007]

85% of Veterans Health Administration (VHA) facilities offer individual psychotherapy specifically for women veterans with substance use disorders (SUD), indicating a strong commitment to addressing their needs.

However, only 30% of facilities provide women-only group therapy for SUD, and just 14% offer women-only groups for SUD-related post-traumatic stress disorder, highlighting a gap in specialized group treatment options for women veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance Use Disorder Treatment Services for Women in the Veterans Health Administration. Timko, C., Hoggatt, KJ., Wu, FM., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40409752/

Development and Pilot Testing of an Addiction Clinic ... This addiction clinic-based behavioral intervention aims to increase PrEP uptake and adherence among racial or ethnic minority women.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06158607

Pre-exposure Prophylaxis (PrEP) Adherence Intervention ... Study Overview · Behavioral : Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders · Other : Standard of care treatment.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144480/

Development and Pilot Testing of an Addiction Clinic ... This addiction clinic–based behavioral intervention aims to increase PrEP uptake and adherence among racial or ethnic minority women who engage in sexual and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875925000463

Implementing a pre-exposure prophylaxis (PrEP) ... We are conducting a clinical trial to evaluate the impact of contingency management (CM) with stepped care to PrEP adherence and support services (PASS) among ...

5. dovepress.com dovepress.com/preference-for-and-efficacy-of-a-prep-decision-aid-for-women-with-subs-peer-reviewed-fulltext-article-PPA

PrEP Decision Aid for Women with Substance Use Disorders The current study aims to address deficits in PrEP scale-up for women with SUDs by empowering them to make informed choices about effective HIV ...

6. aetc.uthscsa.edu aetc.uthscsa.edu/wp-content/uploads/sites/48/2022/11/HIV-SUD-Prevention-and-Care.pdf

HIV Prevention and Care among Substance Using ... The overarching goal of this research is to establish a mental health clinic-based behavioral intervention for increasing PrEP uptake and adherence among women ...