Virtual Support Group for PrEP Use in HIV Prevention

(GODDESS Trial)

Overseen By Felicia A Browne, ScD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: RTI International

Disqualifiers: HIV positive, Previous study participation

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile health app, with or without a virtual support group, can help young African American women reduce alcohol use and risky sexual behavior while increasing PrEP use—a medication that helps prevent HIV. Researchers will divide participants into two groups: one using only the app (mHealth-Women's CoOp) and the other using the app plus the virtual support group. The trial seeks HIV-negative African American women, aged 18 to 30, who have recently used substances and own a smartphone. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new health improvement strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual support group intervention is safe?

Research has shown that mobile health (mHealth) tools, such as the mHealth-Women's CoOp app used in this study, help individuals adhere to their pre-exposure prophylaxis (PrEP) medication routines. Although specific safety data for the Virtual Support Group feature of the app is unavailable, mHealth tools generally provide safe educational and supportive resources.

The app aims to reduce risky behaviors related to HIV and alcohol use. It is specifically tailored for young African American women, potentially enhancing its effectiveness. Since this trial tests a digital tool rather than a new drug, it presents fewer safety concerns compared to drug trials. Participants might notice changes in behavior or mood, but serious side effects are unlikely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PrEP use in HIV prevention because they leverage mobile health technology to address not just the medical aspects of prevention but also behavioral and social factors. The mHealth-Women’s CoOp app provides a tailored intervention focusing on reducing alcohol and drug use, which are key risk factors, specifically designed for young African American women. The enhanced version adds a virtual peer group component, offering social support that can improve engagement and adherence. This multifaceted approach is different from traditional prevention methods, which often focus solely on medication without addressing these crucial behavioral and social elements.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research shows that mobile health (mHealth) apps can help people reduce alcohol consumption and engage in safer sexual practices. One study found that using these apps with counseling completely eliminated risky sexual behavior among participants. Another review of mHealth tools for preventing HIV highlighted their potential to increase the use of pre-exposure prophylaxis (PrEP), a medication that helps prevent HIV infection. In this trial, participants in the "Standard: mHealth-Women's CoOp" arm will receive an evidence-based mHealth intervention. Meanwhile, those in the "Enhanced: mHealth-Women's CoOp+Group" arm will receive the same mHealth intervention along with a virtual peer group component. Adding a virtual support group is expected to enhance these benefits by offering peer support and encouraging more interaction with the app. Overall, combining the mHealth app with group support aims to improve PrEP use and promote safer behaviors. ^{1 3 6 7 8}

Who Is on the Research Team?

Felicia A Browne, ScD, MPH

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

This trial is for young African American women aged 18-30 who misuse alcohol, are HIV-negative, and not on PrEP. Participants must own a smartphone with Android or iOS. Women who have tested positive for HIV or participated in related studies can't join.

Inclusion Criteria

Identify as Black/African American

Have an Android or iOS-based smartphone

Recent substance use

Exclusion Criteria

Test positive for HIV

Participated in the previous study activities of the current study or previous related studies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the mHealth app or the mHealth app plus the group component

6 months

App installation visit

Follow-up

Participants are monitored for biobehavioral outcomes including alcohol use, PrEP uptake, and sexual risk at 3- and 6-month intervals

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• mHealth-Women's CoOp
• Virtual Group

Trial Overview

The study compares two approaches: one group uses an mHealth app, while the other uses the mHealth app plus virtual group support. The aim is to see if adding group support helps reduce alcohol use, lowers sexual risk, and increases PrEP usage over a year.

How Is the Trial Designed?

Group I: Enhanced: mHealth-Women's CoOp+Group Experimental Treatment 2 Interventions

Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young African American women, in addition to a virtual peer group component. The app with a link to the virtual group will be installed on each participant's smartphone by study staff after randomization.

Group II: Standard: mHealth-Women's CoOp Active Control 1 Intervention

Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young African American women. The app will be installed on each participant's smartphone by study staff after randomization.

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Recruited

942,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

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]

An enhanced adherence support program (enPrEP) for oral PrEP did not significantly improve adherence rates among Black MSM and TGW, with only 30% adherence reported at 12 months.

Factors such as lower education levels and depressive symptoms were associated with lower adherence, highlighting the need for innovative strategies to improve PrEP adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pre-exposure Prophylaxis in Black Men Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY. Colson, PW., Franks, J., Wu, Y., et al.[2022]

HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV, yet many eligible individuals are not receiving it, highlighting a gap in access to this important preventive measure.

Recommendations from PrEP Coordinators in San Francisco emphasize the need for better training, integration of PrEP into routine care, and proactive strategies to improve patient retention and communication, particularly for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. Shrestha, I., Ming, K., Jimenez, V., 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]

In a randomized clinical trial involving 229 MSM participants, providing automated feedback through a mobile app did not reduce the number of participants with poor adherence to preexposure prophylaxis (PrEP), with 16% in the intervention group showing poor adherence compared to 11% in the control group.

However, the app feedback significantly increased the proportion of participants achieving excellent adherence (48% in the intervention group vs. 31% in the control group), indicating that while it didn't help those struggling with adherence, it did support those already adhering well to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. van den Elshout, MAM., Hoornenborg, E., Achterbergh, RCA., et al.[2023]

A systematic search identified only 11 out of 621 mobile apps that effectively support the uptake and adherence of PrEP, indicating a significant gap in available resources for at-risk individuals.

The evaluated apps showed moderate effectiveness in facilitating PrEP use by providing essential information and resources, and they received an acceptable quality rating, suggesting they could help increase PrEP uptake among those at risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. Sharpe, JD., Kamara, MT.[2019]

Citations

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Virtual Support Group for PrEP Use in HIV Prevention

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This pilot study is the first step in designing and implementing an mHealth HIV prevention and PrEP promotion intervention tailored for young Black women.

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Peer Outreach and Navigation Intervention to Increase ...

The investigators will conduct self-report surveys at baseline and at a week 4-12 follow-up visit that will collect data about sexual and drug use risk ...