The Dreamer Girls Project: Adaptation of SISTA/SIHLE for HIV/AIDS and Substance Abuse Prevention Among Black Adolescent Girls

NCT05014074 | Not Yet Recruiting DMC

• 2 other identifiers: 20000266602R25MH087217-11
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

HIV/AIDS

Keywords

Black adolescent girls

Outcome Measures

Primary Outcomes (6)

• 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 Services Administration, 2006) and Youth Risk Behavior Survey. The scale consisted of three items that assesses how often participants smoked cigarettes, drank alcohol, and smoked marijuana in the past 30 days. An example of an item is, "Estimate the number of days you used marijuana or hashish in the last 30 days." Participants responded to these items on a 7-point scale (1 = 0 days; 2 =1-2 days, 3 = 3-5 days; 4 = 6-9 days; 5 = 10-19 days; 6 = 20-29 days; 7 = All 30 days). The sum of this scale is the mean of responses on the three items, with higher scores indicating greater frequency of use.

  30 days

• Change in perception of drug use risk

  To assess the perceived risk of using alcohol, tobacco, and marijuana, adapted questions from the Monitoring the Future study will be used. Questions such as: perceived risk of moderate daily drinking, heavy drinking, combining alcohol with marijuana, daily smoking and heavy, daily and heavy marijuana use. The choices are: 0=Can't Say/Drug Unfamiliar, 1=No risk, 2=Slight risk, 3=Moderate risk, 4=Great risk. All of the items will be summed together. Higher score indicates greater perception of risk from using alcohol and drugs

  Baseline, 30 days, 60 days

• Change in perception of sexual risk

  Perception of Sexual Risk was assessed using eight items that measured participants' perception of sexual risk (sample item: How much do you think people risk harming themselves physically if they have sex without a condom or dental dam?) and substance use risk (sample item: How much do people risk harming themselves physically or in other ways when they smoke marijuana once or twice a week?). Items will be summed and higher scores will indicate greater perceived risk

  Baseline, 30 days, 60 days

• Change in HIV knowledge

  HIV Knowledge will be assessed using eight items that measured participants' HIV knowledge (sample item: Only people who look sick can spread the HIV/AIDS virus.). Responses were recorded using True (1) or False (0). Items will be summed and higher scores indicated greater HIV knowledge

  Baseline, 30 days, 60 days

• Change in sexual risk behavior

  Sexual Risk Behavior: Six items will be adapted from the National Youth Risk Behavior Survey , which assess sexual behavior among high school aged adolescents. These items included: having ever had vaginal sex, how many times participants had sex in the past 3 months, number of lifetime sexual partners, age of first sexual intercourse, having sex under the influence of drugs and alcohol, and having unprotected sex without a condom. A composite score will be used where the range of score is 0 to 30, the higher the score the more perception of risk

  Baseline, 30 days, 60 days

• Change in ethnic identity

  Multigroup Ethnic Identity Measure (MEIM) Revised consists of six questions and will be used to measure ethnic identity. Responses using a 4-point Likert-type scale will range from Strongly disagree (1) to Strongly agree (4). Scores were totaled by summing responses, with higher scores representing greater ethnic identification (Cronbach α = .86). Responses on the original MEIM ranged from 20 to a maximum of 80.

  Baseline, 30 days, 60 days

Study Arms (1)

Theater/Pilot Testing

EXPERIMENTAL

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

Other: Theater/Pilot Testing

Interventions

Theater/Pilot Testing OTHER

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

Theater/Pilot Testing

Eligibility Criteria

• Age: 13 Years - 18 Years
• Gender Eligibility Details: participants that identify themselves as females
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• not identify as Black/African American only
• be under the age of 13 or over the age of 18
• no parental consent provided
• no youth assent provided
• does not live in Paterson
• does not read, speak or write in English
• is currently pregnant

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Paterson Youth Services Bureau

Paterson, New Jersey, 07522, United States

Location

Related Publications (1)

• Opara I, Gabriel C, Duran-Becerra B, Bond K, Hill AV, Hussett-Richardson S, Alves C, Kershaw T. Sexual Health and Drug Use Prevention for Black Girls (The Dreamer Girls Project): Protocol for an Intervention Development. JMIR Res Protoc. 2023 Aug 9;12:e45007. doi: 10.2196/45007.

  PMID: 37556188 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Ijeoma Opara, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ijeoma Opara, PhD

CONTACT

908-494-3493; ijeoma.opara@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 20, 2021
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)