What side effects are associated with this type of intervention?

Common treatments for sexually transmitted diseases (STDs) include antibiotics for bacterial infections like chlamydia and gonorrhea, antiviral medications for viral infections like herpes and HIV, and behavioral interventions for prevention and management. Antibiotics can cause side effects such as gastrointestinal upset, allergic reactions, and yeast infections. Antiviral medications may lead to headaches, nausea, and fatigue. Behavioral interventions, including cognitive behavioral therapy (CBT) and mobile health (mHealth) applications, generally have minimal physical side effects but may cause emotional discomfort as patients confront and modify their behaviors. Overall, while pharmacologic treatments have more tangible side effects, behavioral interventions focus on psychological and social support with fewer physical risks.

What prior FDA approvals exist?

The FDA has approved several treatments for sexually transmitted diseases (STDs), including antibiotics for bacterial infections like chlamydia, gonorrhea, and syphilis, and antiviral medications for viral infections such as herpes and HIV. For HIV prevention, pre-exposure prophylaxis (PrEP) drugs like emtricitabine/tenofovir disoproxil fumarate (Truvada) and emtricitabine/tenofovir alafenamide (Descovy) have been approved. These treatments align with the goals of the modified mHealth intervention trial, which aims to enhance PrEP utilization and reduce sexual risk behaviors.

What other types of research exist?

Promising, novel alternatives for STDs patients considering treatment in 2024 include: 1) Internet-based interventions, which have shown efficacy in smoking cessation and binge eating disorder management. 2) Mobile phone text messaging and app-based interventions, which provide real-time support and monitoring. 3) Telephonic counseling, offering personalized support remotely. 4) Digital Cognitive Behavioral Therapy (CBT), which has been effective in treating insomnia and other behavioral health issues. These alternatives leverage technology to provide accessible, scalable, and effective behavioral support.

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Virtual Support Group for PrEP Use in HIV Prevention (GODDESS Trial)

N/A

Waitlist Available

Led By Felicia A Browne, ScD, MPH

Research Sponsored by RTI International

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a smartphone health app, with some people also joining online meetings. It targets young African American women who misuse alcohol and are HIV-negative. The app provides tracking and tips to reduce risky behaviors, while the meetings add peer support.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-medical interventions like mobile health applications and virtual groups discussions, traditional medication side effects are not expected; however, participants may experience privacy concerns or emotional distress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcohol (Biological)

Alcohol (Self-Reported)

PrEP Utilization (Biological)

+4 more

Secondary study objectives

Drug Use (Biological)

Drug Use (Self-Reported)

Gender-based Violence

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced: mHealth-Women's CoOp+GroupExperimental Treatment2 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 CoOpActive Control1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sexually transmitted diseases (STDs) often include behavioral modification and support interventions, such as cognitive-behavioral therapy (CBT) and motivational enhancement therapy (MET). These therapies help patients identify and change risky behaviors, improve coping mechanisms, and increase motivation to adhere to preventive measures. This approach is essential for STD patients as it not only treats the current infection but also reduces the risk of future infections by fostering long-term behavioral changes.