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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

GODDESS Trial Summary

This trial tests a modified mobile health program to reduce alcohol use, sexual risk and increase PrEP use among 500 HIV-negative African American women.

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.Check my eligibility

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.See study design

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.

GODDESS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alcohol (Biological)

Alcohol (Self-Reported)

PrEP Utilization (Biological)

+4 more

Secondary outcome measures

Drug Use (Biological)

Drug Use (Self-Reported)

Gender-based Violence

+1 more

GODDESS 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

RTI InternationalLead Sponsor

188 Previous Clinical Trials

875,464 Total Patients Enrolled

8 Trials studying Sexually Transmitted Diseases

23,442 Patients Enrolled for Sexually Transmitted Diseases

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

800 Previous Clinical Trials

1,362,497 Total Patients Enrolled

4 Trials studying Sexually Transmitted Diseases

1,190 Patients Enrolled for Sexually Transmitted Diseases

Felicia A Browne, ScD, MPHPrincipal InvestigatorRTI International

Media Library

mHealth-Women's CoOp Clinical Trial Eligibility Overview. Trial Name: NCT05753683 — N/A

Sexually Transmitted Diseases Research Study Groups: Standard: mHealth-Women's CoOp, Enhanced: mHealth-Women's CoOp+Group

Sexually Transmitted Diseases Clinical Trial 2023: mHealth-Women's CoOp Highlights & Side Effects. Trial Name: NCT05753683 — N/A

mHealth-Women's CoOp 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753683 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to register as a participant in this experiment?

"In order to be considered as a candidate, an individual should have HIV/AIDS and fit between the ages of 18-30. This clinical trial is currently looking for 500 volunteers in total."

Answered by AI

Is there still room for participants in this experiment?

"This clinical study, which was originally published on July 1st 2023 and last edited on February 22nd 2023, is not presently recruiting candidates. According to the same source, there are 275 other trials actively seeking patients at this time."

Answered by AI

Does this research require participants to meet an age criterion of less than 35 years?

"Per the eligibility requirements, only those aged between 18 and 30 may participate. There are 72 trials for people in the juvenile age-group while there are 198 studies catering to elderly patients."

Answered by AI

What are the main goals of this trial?

"Over the course of 12 months, this scientific endeavour will evaluate Alcohol Consumption (Self-Reported) with supplementary objectives that include Drug Usage (as assessed by The World Health Organization's Alcohol, Smoking & Substance Use Involvement Scale), Perceived Social Support (via the Multidimensional Scale of Perceived Social Support), and Gender-based Violence (measured through the WHO gender-based violence scale)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gathering Online for Dialogue and Discussion to Enhance Social Support

2023. "Gathering Online for Dialogue and Discussion to Enhance Social Support". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05753683.