Clinical trial NCT05014074: The Dreamer Girls Project: Adaptation of SISTA/SIHLE for HIV/AIDS and Substance Abuse Prevention Among Black Adolescent Girls
Official title: The Dreamer Girls Project: Adaptation of SISTA/SIHLE for HIV/AIDS and Substance Abuse Prevention Among Black Adolescent Girls
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: Black adolescent girls
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-08-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria

1. Identify as a Black/African American female
2. Be between the ages of 13-18 years old;
3. Consent to being a part of the study (Parent consent and youth assent if under 18 years old);
4. Live in Paterson, New Jersey at the time of the study;
5. English as their first language.

Exclusion Criteria

1. not identify as Black/African American only
2. be under the age of 13 or over the age of 18
3. no parental consent provided
4. no youth assent provided
5. does not live in Paterson
6. does not read, speak or write in English
7. is currently pregnant

Primary outcomes:
measure: Change in 30-day drug use
timeFrame: 30 days
measure: Change in perception of drug use risk
timeFrame: Baseline, 30 days, 60 days
measure: Change in perception of sexual risk
timeFrame: Baseline, 30 days, 60 days
measure: Change in HIV knowledge
timeFrame: Baseline, 30 days, 60 days
measure: Change in sexual risk behavior
timeFrame: Baseline, 30 days, 60 days
measure: Change in ethnic identity
timeFrame: Baseline, 30 days, 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paterson
country: United States
facility: Paterson Youth Services Bureau
state: New Jersey
Study officials:
affiliation: Yale University
name: Ijeoma Opara, PhD
role: PRINCIPAL_INVESTIGATOR
References: