What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS, such as antiretroviral therapy (ART), often include drugs like dolutegravir and lamivudine. Known side effects of these treatments can include gastrointestinal issues (nausea, diarrhea), headaches, fatigue, and potential metabolic complications. Long-term use may lead to more serious effects such as liver toxicity, kidney problems, and bone density loss. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What other types of research exist?

Promising alternatives to focus group methodology for qualitative data collection among HIV/AIDS patients include: 1) Asynchronous online discussions, which allow participants to contribute at their convenience and can reach a broader audience. 2) Mobile health (mHealth) apps that facilitate real-time data collection and patient engagement. 3) Virtual reality (VR) environments that create immersive experiences for more in-depth qualitative insights. 4) Social media platforms for community-driven discussions and data collection. 5) Digital storytelling, where patients share their experiences through multimedia formats.

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Not Applicable

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

Q: What prior FDA approvals exist?

The FDA has approved numerous antiretroviral drugs for the treatment of HIV/AIDS, which are often used in combination to manage the disease effectively. These include nucleoside reverse transcriptase inhibitors (NRTIs) like zidovudine, non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as efavirenz, protease inhibitors (PIs) like ritonavir, and integrase strand transfer inhibitors (INSTIs) such as raltegravir. These treatments aim to reduce the viral load, improve immune function, and prevent the progression to AIDS.

N/A

Waitlist Available

Led By Ijeoma Opara, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Identify as a Black/African American female

Be between the ages of 13-18 years old

Must not have

Is under the age of 13 or over the age of 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 30 days, 60 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to adapt an HIV prevention program for Black girls aged 13-18 in Paterson. The process involves gathering input from the girls, forming a group of community members for advice, and testing the adapted program. This ensures the intervention is relevant and effective for the target group.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves theater activities and discussions rather than medical treatments, traditional physical side effects are not expected. However, emotional discomfort due to sensitive topics discussed may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a Black/African American woman.

Select...

I am between 13 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am either younger than 13 or older than 18.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 30 days, 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 30 days, 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 days, 60 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in 30-day drug use

Change in HIV knowledge

Change in ethnic identity

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Theater/Pilot TestingExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

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

The most common treatments for HIV/AIDS involve antiretroviral therapy (ART), which includes several classes of drugs: nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) inhibit the reverse transcriptase enzyme, preventing the conversion of viral RNA into DNA; protease inhibitors (PIs) block the protease enzyme, preventing viral replication; integrase strand transfer inhibitors (INSTIs) inhibit the integrase enzyme, preventing the integration of viral DNA into the host genome; and entry inhibitors prevent the virus from entering host cells. These mechanisms are vital as they collectively reduce the viral load, enhance immune function, and prevent the progression to AIDS, thereby significantly improving the quality of life and longevity of HIV/AIDS patients.

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