Prevention Program Adaptation for HIV/AIDS and Substance Abuse in Black Adolescent Girls

Overseen By Ijeoma Opara, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Non-Black, Outside age range, Pregnant, others

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

Compensation: Varies

Number of Visits: 30

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to adapt and improve a prevention program focused on HIV/AIDS and substance abuse specifically for Black adolescent girls. Participants will engage in the SISTA/SIHLE Adaptation, a prevention program, along with theater and pilot testing to provide feedback on the program's effectiveness and relevance. It suits Black or African American girls aged 13 to 18 who live in Paterson, New Jersey, and speak English as their first language. The goal is to gather insights that can enhance the program's impact on the community. As an unphased trial, this study offers participants the chance to contribute to developing a culturally relevant prevention program.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that this program adaptation is safe for participants?

Research shows that the SISTA/SIHLE program adapts existing methods to address HIV/AIDS and substance abuse among Black teenage girls. These methods have been thoroughly studied and successfully used in the past. Based on proven programs, they are generally considered safe for participants.

The sources provided do not specify side effects or safety issues. However, the study's "Not Applicable" phase indicates a focus on adapting and testing the program's effectiveness, rather than testing a new drug or risky treatment. This typically suggests the program is low-risk and manageable for participants.

Participants will engage in activities like theater and pilot testing to enhance the program. These activities, common in behavioral programs, carry minimal risk and emphasize education and prevention strategies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SISTA/SIHLE Adaptation because it combines theater-based interventions with feedback from participants to make the program more engaging and effective. Unlike traditional approaches that may rely on static educational sessions, this method involves active participation and adapts based on real-time input from Black adolescent girls. This dynamic process aims to better address the unique cultural and social factors that influence HIV/AIDS and substance abuse prevention in this community, potentially leading to more impactful outcomes.

What evidence suggests that this trial's treatments could be effective for HIV/AIDS and substance abuse prevention in Black adolescent girls?

Research has shown that the SISTA/SIHLE programs effectively help prevent HIV and substance abuse. These programs aim to empower Black teenage girls by enhancing their understanding and skills related to sexual health and substance abuse prevention. Studies have found that girls participating in SISTA/SIHLE programs often change risky behaviors, such as using fewer drugs and practicing safer sex. The programs include engaging activities, like videos and group discussions, to make the information both enjoyable and effective. In this trial, participants will engage in theater/pilot testing to provide feedback and make substantive changes to the intervention, ensuring it meets the specific needs of the community it serves. ^{1 2 3 4 6}

Who Is on the Research Team?

Ijeoma Opara, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for Black/African American girls aged 13-18 living in Paterson, New Jersey. They must speak English as their first language and have both parent consent and youth assent if under 18. It's not open to those who are pregnant, over 18 or under 13, don't identify as Black/African American only, or lack parental consent.

Inclusion Criteria

I am a Black/African American woman.

English as their first language

Live in Paterson, New Jersey at the time of the study

Exclusion Criteria

No parental consent provided

No youth assent provided

Is currently pregnant

Timeline for a Trial Participant

Assessment

Conducting focus groups with Black girls aged 13-18 to gain input on the intervention

2-4 weeks

Multiple focus group sessions

Decision Making

Creation of a community advisory board to decide on the appropriate intervention and modify components

2-4 weeks

Advisory board meetings

Adaptation

Using theater testing to adapt the SIHLE intervention with feedback from Black adolescent girls

4 weeks

Theater testing sessions

Follow-up

Participants are monitored for changes in HIV knowledge, perception of sexual risk, drug use risk, and ethnic identity

8 weeks

Assessments at baseline, 30 days, and 60 days

What Are the Treatments Tested in This Trial?

Interventions

• SISTA/SIHLE Adaptation
• Theater/Pilot Testing

Trial Overview

The study is testing a theater-based program adapted from SISTA/SIHLE designed for HIV/AIDS and substance abuse prevention among the participants. The effectiveness will be evaluated using focus groups to gather detailed feedback on the interaction between participants.

How Is the Trial Designed?

Group I: Theater/Pilot Testing Experimental Treatment 1 Intervention

Participants will take part in a theater/pilot testing in order to receive adequate feedback and make substantive change in the intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05014074

The Dreamer Girls Project: Adaptation of SISTA/SIHLE for ...

Change in 30-day drug use, Past 30-day drug use will be measured using items from the National Survey on Drug Use and Health (Substance Abuse and Mental Health ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4344934/

SiHLEWeb.com: Development and Usability Testing ...

... HIV/STI prevention, dating violence, and pregnancy prevention. Focus group ... use of videos to teach content and to meet the SiHLE participants. The ...

3.

withpower.com

withpower.com/trial/prevention-program-adaptation-for-hivaids-and-substance-abuse-in-black-adolescent-girls-c5ca3

Prevention Program Adaptation for HIV/AIDS and ...

Prevention Program Adaptation for HIV/AIDS and Substance Abuse in Black Adolescent Girls ... We use your data solely to fulfill our mission: helping you find ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4933957/

Adapting an Evidence-Based HIV-Prevention Intervention ...

Women who experience IPV may use and abuse alcohol and drugs to cope with the negative sequelae of IPV (Gilbert, El-Bassel, Rajah, Foleno, & Frye, 2001; Kaysen ...

5.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05014074?keyword=%22Adolescent%20Girls%22

Adaptation of SISTA/SIHLE for HIV/AIDS and Substance ...

To effectively implement the intervention, this study will use the ADAPT-ITT. Drs. Wingood and DiClemente have systematically developed a framework for adapting ...

6.

app.trialscreen.org

app.trialscreen.org/trials/hiv-aids-dreamer-girls-project-adaptation-sista-sihle-substance-abuse-trial-nct05014074

Adaptation of SISTA/SIHLE for HIV/AIDS and Substance ...

The Dreamer Girls Project: Adapting HIV/AIDS and Substance Abuse Prevention Intervention ... This study aims to adapt an existing evidence-based intervention ( ...