Counseling Program for Black Women with HIV

Overseen By Shine Research

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: Antiretroviral therapy

Disqualifiers: Active psychosis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 1.5 years

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a counseling program specifically designed for Black women living with HIV. The program, STEP-AD, includes 10 sessions focused on empowerment and adherence to HIV medication routines. Participants will be involved for up to 1.5 years and may be a good fit if they are Black women diagnosed with HIV, have a history of trauma, and are currently on Antiretroviral Therapy (ART) medicines. As an unphased trial, this study offers a unique opportunity to contribute to research that could empower and improve the lives of Black women living with HIV.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should be currently taking Antiretroviral Therapy (ART) medicines. It seems likely that you will continue your ART medications during the study.

What prior data suggests that this counseling program is safe for Black women with HIV?

Research shows that the STEP-AD program, which stands for "Striving Towards EmPowerment and Medication Adherence," is a counseling treatment designed to help Black women with HIV adhere to their medication plans. Studies indicate it uses safe and well-known methods from cognitive behavioral therapy, which helps people change their thoughts and actions to improve their lives.

The program includes 10 sessions focused on helping participants take their medications as prescribed. Previous studies have not reported any harmful effects from this counseling approach. Since it doesn’t involve medication, it’s generally considered safe for participants. For any concerns, discussing with a healthcare provider can help determine if joining this study is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEP-AD program because it offers a personalized approach to improving medication adherence and empowerment for Black women living with HIV. Unlike typical treatments that focus solely on medical interventions, STEP-AD combines behavioral medicine with empowerment strategies in a structured 10-session program. This holistic method aims to address both the psychological and practical challenges of managing HIV, potentially leading to better health outcomes and a higher quality of life for participants.

What evidence suggests that this trial's treatments could be effective for Black women living with HIV?

Research shows that STEP-AD, a treatment arm in this trial, is a promising program for Black women living with HIV. Earlier studies found that this 10-session counseling treatment helped participants take their HIV medicine more regularly. Taking medicine as prescribed can lead to lower levels of the virus in the body, known as viral suppression. The program uses strategies to change thinking and behavior to support health goals. Early evidence suggests that STEP-AD can significantly aid in managing HIV. ^{1 2 3 6 7}

Who Is on the Research Team?

Sannisha Dale, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is specifically for Black women who are living with HIV, have experienced trauma, and are currently on Antiretroviral Therapy (ART). It aims to help them manage their health condition better.

Inclusion Criteria

Black

Living with HIV

I am a cisgender female.

Exclusion Criteria

Unable to completely and fully understand the informed consent process and the study procedures

I do not have untreated severe mental health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the manualized 10 session behavioral medicine intervention titled 'Striving Towards EmPowerment and Medication Adherence' or enhanced treatment as usual over a period of up to 1.5 years

1.5 years

10 in-person sessions

Follow-up

Participants are monitored for changes in engagement in HIV care, PTSD diagnosis, ART adherence, and viral suppression

1.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced treatment as usual (E-TAU)
• STEP-AD

Trial Overview The study is testing a counseling program called STEP-AD against an enhanced usual treatment (E-TAU) to see which one helps participants stick to their medication regimen more effectively.

How Is the Trial Designed?

Group I: STEP-AD Experimental Treatment 1 Intervention

Participants in this arm will receive the manualized 10 session behavioral medicine intervention titled "Striving Towards EmPowerment and Medication Adherence". Participants will be in this group for a total of up to 1.5 years.

Group II: Enhanced treatment as usual Active Control 1 Intervention

Participants in the comparison condition will also complete 10 in person sessions. The first session will consist of a session on healthy living with HIV. The remaining 9 sessions will consist of neutral (daily events) writing. Participants will be in this group for a total of up to 1.5 years.

STEP-AD is already approved in United States, European Union for the following indications:

Approved in United States as Antiretroviral Therapy for:

• HIV/AIDS

Approved in European Union as Antiretroviral Therapy for:

• HIV/AIDS

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The Tonse Pamodzi intervention is designed to enhance adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) among pregnant and breastfeeding women, integrating both biomedical and behavioral components for better support.

This adaptable intervention includes patient-centered counseling and allows women to select an adherence supporter, which may improve their engagement and adherence to HIV treatment, potentially aiding in the elimination of mother-to-child transmission of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tonse Pamodzi: Developing a combination strategy to support adherence to antiretroviral therapy and HIV pre-exposure prophylaxis during pregnancy and breastfeeding. Hill, LM., Saidi, F., Freeborn, K., et al.[2021]

In a study of 198 older people with HIV, Black patients had a significantly lower percentage of undetectable viral loads (61.8%) compared to White (85.8%) and Hispanic (83.3%) patients, indicating disparities in treatment effectiveness.

Despite the differences in viral load suppression, there were no significant safety concerns or changes in metabolic, hepatic, or renal parameters among the racial and ethnic groups, suggesting that while efficacy varies, the safety of antiretroviral therapy remains consistent across these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Safety and Effectiveness of Antiretroviral Therapy in a Diverse Population of Older People With HIV. Chahine, EB., Nunez-Medina, RM., Williams, K., et al.[2023]

Among 149 HIV-positive women studied, adherence to antiretroviral therapy (ART) decreased from 57% during pregnancy to 45% postpartum, highlighting the need for ongoing support after childbirth.

Women with a history of illicit drug use or those who missed prenatal vitamins were significantly more likely to be nonadherent to ART, suggesting that targeted interventions for these groups could improve adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prior illicit drug use and missed prenatal vitamins predict nonadherence to antiretroviral therapy in pregnancy: adherence analysis A5084. Cohn, SE., Umbleja, T., Mrus, J., et al.[2019]

Black women living with HIV face significant barriers to care, including lack of social support, poor quality of HIV services, and stigma from healthcare providers, which negatively impact their health outcomes.

Facilitators of care for Black women include resilience, supportive relationships with case management, and a strong awareness of racial issues; addressing these factors and reducing stigma among healthcare providers could improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social and structural determinants of HIV treatment and care among black women living with HIV infection: a systematic review: 2005-2016. Geter, A., Sutton, MY., Hubbard McCree, D.[2022]

The Act Healthy (AH) intervention led to significantly greater reductions in cravings for substance use compared to supportive counseling, although it did not result in a significant decrease in overall substance use among the 61 participants over one year.

Both the AH and supportive counseling groups showed a significant increase in the likelihood of being on antiretroviral therapy (ART), with 86% of participants on ART at 12 months compared to 56% at baseline, indicating improved medication adherence in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Act Healthy: A Randomized Clinical Trial Evaluating a Behavioral Activation Intervention to Address Substance Use and Medication Adherence Among Low-Income, Black/African American Individuals Living with HIV/AIDS. Magidson, JF., Belus, JM., Seitz-Brown, CJ., et al.[2022]

In a study of 1301 HIV-infected participants over a median follow-up of 5 years, significant differences in the risk of specific adverse events were observed based on gender and race, with black participants showing higher risks for cardiovascular and renal events, and women having a greater risk for anemia.

Despite these differences in specific adverse events, the overall rates of adverse events, all-cause mortality, and treatment discontinuations due to toxicity were similar across gender and racial groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethnicity, race, and gender. Differences in serious adverse events among participants in an antiretroviral initiation trial: results of CPCRA 058 (FIRST Study). Tedaldi, EM., Absalon, J., Thomas, AJ., et al.[2022]

The pilot study involving 14 African American women living with HIV in rural Florida demonstrated that the Wisepill medication event-monitoring system (MEMS) was successfully used by the majority of participants, indicating its feasibility for tracking antiretroviral therapy (ART) adherence.

Objective ART adherence measured by MEMS was found to be 81.08%, closely aligning with the self-reported adherence of 77.78%, suggesting that the MEMS can provide reliable data for future research on ART adherence among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an Electronic Medication Event-Monitoring System for Antiretroviral Therapy Self-Management Among African American Women Living With HIV in Rural Florida: Cohort Study. Lucero, R., Williams, R., Esalomi, T., et al.[2023]

Women who received prior ART-readiness counseling through PMTCT programs demonstrated more accurate beliefs and positive attitudes about ART compared to those without prior counseling, indicating the importance of such educational interventions.

Despite some retained knowledge, both groups showed a lack of understanding of basic HIV biology, highlighting the need for tailored education to improve ART adherence and address misconceptions that could lead to treatment resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial Aspects of ART Counseling: A Comparison of HIV Beliefs and Knowledge in PMTCT and ART-Naïve Women. Gouse, H., Henry, M., Robbins, RN., et al.[2023]

In a study of 1703 Black women with HIV, those who had not been incarcerated in the past year and had not faced discrimination in healthcare were more likely to adhere to antiretroviral therapy (ART).

Women living above the federal poverty level showed a higher likelihood of achieving viral suppression, highlighting the importance of social determinants of health in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological and social determinants of health, antiretroviral therapy (ART) adherence, and viral suppression among HIV-positive black women in care. Bradley, ELP., Frazier, EL., Carree, T., et al.[2022]

The counseling tools developed in Project MOTIV8 significantly improved participants' knowledge about antiretroviral therapy (ART) adherence, with a 12.4% increase in knowledge among intervention participants compared to a 1.8% decrease in the control group after 48 weeks.

Participants reported high satisfaction with the counseling tools, with 80% feeling that the counseling helped them adhere to their medications, indicating that these tools could be effectively integrated into clinical practice, especially for patients with lower education levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient communication tools to enhance ART adherence counseling in low and high resource settings. Finocchario-Kessler, S., Catley, D., Thomson, D., et al.[2022]

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]

The intervention using text reminders and data-informed counseling did not significantly improve overall adherence to antiretroviral therapy (ART) among 133 pregnant women living with HIV in Uganda, with only 16.4% achieving ≥95% adherence compared to 9.1% in the standard care group.

However, participants who actively used the adherence monitors as intended showed better outcomes, indicating that while the overall intervention was ineffective, it may still benefit certain individuals who engage with the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time Feedback to Improve HIV Treatment Adherence in Pregnant and Postpartum Women in Uganda: A Randomized Controlled Trial. Sabin, LL., Simmons, E., Halim, N., et al.[2023]

A study involving 700 HIV-infected women revealed that 55% had never discussed gender-specific treatment issues with their healthcare providers, indicating significant communication gaps.

Among women who were or had been pregnant, 57% had not discussed appropriate HIV treatment regimens with their providers, highlighting the need for better reproductive counseling in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health needs of HIV-infected women in the United States: insights from the women living positive survey. Squires, KE., Hodder, SL., Feinberg, J., et al.[2021]

A culturally targeted multi-component intervention for African American/Black and Latino adults with HIV showed promising results, with 60% of participants demonstrating good adherence to antiretroviral therapy (ART) compared to 26.7% in the control group after 8 months.

Participants in the intervention group also had significantly lower viral load levels than those receiving standard care, indicating that the intervention may effectively improve both adherence and health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral intervention improves treatment outcomes among HIV-infected individuals who have delayed, declined, or discontinued antiretroviral therapy: a randomized controlled trial of a novel intervention. Gwadz, M., Cleland, CM., Applegate, E., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6103625/

Striving Towards Empowerment and Medication Adherence ... STEP-AD is a 10-session treatment aimed at improving medication adherence for Black women with HIV by combining established cognitive behavioral strategies.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02764853

Striving Towards EmPowerment and Medication ... STEP-AD is a research study aimed at developing an intervention for Black women living with HIV to address psychosocial factors.

3. link.springer.com link.springer.com/article/10.1007/s10461-024-04408-w

A Pilot Randomized Control Trial of the Striving Towards ... We developed the first intervention for BWLWH to promote medication adherence and ultimately HIV viral suppression. STEP-AD (Striving Towards ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11427489/

A Pilot Randomized Control Trial of the Striving Towards ... We developed the first intervention for BWLWH to promote medication adherence and ultimately HIV viral suppression. STEP-AD (Striving Towards ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722917301037

A Tailored Cognitive Behavioral Treatment Approach for ... Striving Towards EmPowerment and Medication Adherence (STEP-AD) is a 10-session treatment aimed at improving medication adherence for Black women with HIV by ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30147289/

A Tailored Cognitive Behavioral Treatment Approach for Black ... Striving Towards EmPowerment and Medication Adherence (STEP-AD) is a 10-session treatment aimed at improving medication adherence for Black women with HIV by ...

7. grantome.com grantome.com/grant/NIH/K23-MH108439-01

Striving Towards Empowerment and Medication ... Black women with HIV represent the largest proportion of women with HIV in the U.S., and have worse HIV health outcomes (e.g. medication adherence, viral load) ...