The Dreamer Girls Project: Adaptation of SISTA/SIHLE for HIV/AIDS and Substance Abuse Prevention Among Black Adolescent Girls
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ClinicalTrials.gov Identifier: NCT05014074 |
Recruitment Status :
Not yet recruiting
First Posted : August 20, 2021
Last Update Posted : March 6, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | July 19, 2021 | ||||||
First Posted Date ICMJE | August 20, 2021 | ||||||
Last Update Posted Date | March 6, 2024 | ||||||
Estimated Study Start Date ICMJE | July 2024 | ||||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | The Dreamer Girls Project: Adaptation of SISTA/SIHLE for HIV/AIDS and Substance Abuse Prevention Among Black Adolescent Girls | ||||||
Official Title ICMJE | The Dreamer Girls Project: Adaptation of SISTA/SIHLE for HIV/AIDS and Substance Abuse Prevention Among Black Adolescent Girls | ||||||
Brief Summary | The study will use focus group methodology in the formative evaluation phase. Focus group methodology provides a rich source of data and understanding of phenomena by allowing the researcher to examine the interaction among participants | ||||||
Detailed Description | The study is a formative qualitative study design with the intention of using findings for the adaptation and evidence-based intervention. Study Approach: The process of modifying an evidence-based intervention (EBI) without competing with or contradicting its core elements or internal logic is referred to as ''adaptation''. To effectively implement the intervention, this study will use the ADAPT-ITT. Drs. Wingood and DiClemente have systematically developed a framework for adapting HIV-related evidence-based interventions, known as the ''ADAPT-ITT'' model. The ADAPT-ITT model consists of 8 sequential phases that inform HIV prevention providers and researchers of a prescriptive method for adapting evidence-based interventions. ADAPT-ITT has been applied with diverse populations of adolescents and adults in domestic and international settings. Due to time restrictions on the execution of this study, the first three phases of the ADAPT-ITT will be implemented. Phase 1: Assessment involves conducting focus groups with member of the target population. For this study, it will be Black girls between the ages of 13-18 years old. The purpose of this step is to gain input from members of the target population on the intervention before it is introduced. Before implementing the adaptation of SIHLE, it is necessary for facilitators to conduct focus groups with girls who are from the target community and age group. Phase 2: A community advisory board will be created and will involve: leaders of organizations that serve Black adolescent girls in Paterson and Black adolescent girls whom live in Paterson and are a part of the target population. The community advisory board will aid in deciding on the appropriate intervention and modify intervention components to fit the target population. Within the ADAPT-ITT framework, the next phase must include the Decision making phase. Decision phase includes deciding on which HIV intervention to implement on the target population. This stage, the PI has selected SIHLE intervention to be conducted based on a previous needs' assessment on the community. Since there are very limited interventions for Black girls that address HIV/AIDS and drug use, adapting SIHLE to fit the needs of the girls in the community will be implemented. Phase 3: Adaptation involves using an innovative pretesting methodology known as theater testing to adapt the EBI. Using this methodology, a subset of 5-10 Black adolescent girls from the community will be invited to a central location to respond to a demonstration of the adapted SIHLE intervention. The purpose of this registration is for Phase 3 of the study. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | HIV/AIDS | ||||||
Intervention ICMJE | Other: Theater/Pilot Testing
Participants will take part in a theater/pilot testing in order to receive adequate feedback and make substantive change in the intervention
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Study Arms ICMJE | Experimental: Theater/Pilot Testing
Participants will take part in a theater/pilot testing in order to receive adequate feedback and make substantive change in the intervention
Intervention: Other: Theater/Pilot Testing
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||
Estimated Enrollment ICMJE |
10 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 2025 | ||||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 13 Years to 18 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05014074 | ||||||
Other Study ID Numbers ICMJE | 2000026660 2R25MH087217-11 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Yale University | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Yale University | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||
Investigators ICMJE |
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PRS Account | Yale University | ||||||
Verification Date | March 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |