HIV/AIDSNCT05014074
The Dreamer Girls Project: Adaptation of SISTA/SIHLE for HIV/AIDS and Substance Abuse Prevention Among Black Adolescent Girls
A study testing Theater/Pilot Testing in people with HIV/AIDS, run by Yale University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Theater/Pilot Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Paterson Youth Services Bureau
Paterson, New Jersey, 07522
Ijeoma Opara, PhD, MSW, MPH, ijeoma.opara@yale.edu
About this study
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
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Theater/Pilot Testing
- Keywords
- Black adolescent girls
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theater/Pilot TestingOther
Participants will take part in a theater/pilot testing in order to receive adequate feedback and make substantive change in the intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Theater/Pilot Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, 30 days, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study startJan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ijeoma Opara, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014074
- Sponsor's protocol ID
- 2000026660
- Other IDs
- 2R25MH087217-11
- Status last verified
- Oct 2025
- First submitted
- 19 Jul 2021
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37556188
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dreamer Girls Project: Adaptation of SISTA/SIHLE for HIV/AIDS and Substance Abuse Prevention Among Black Adolescent Girls
- ClinicalTrials.gov ID
- NCT05014074
- Acronym / sponsor ID
- 2000026660
- Conditions
- HIV/AIDS
- Keywords
- Black adolescent girls
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theater/Pilot Testing | Experimental | Other: Theater/Pilot TestingParticipants will take part in a theater/pilot testing in order to receive adequate feedback and make substantive change in the intervention |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theater/Pilot TestingParticipants 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 |
Primary outcome
Change in 30-day drug use
Time frame: 30 days
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.
Change in perception of drug use risk
Time frame: Baseline, 30 days, 60 days
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
Change in perception of sexual risk
Time frame: Baseline, 30 days, 60 days
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
Change in HIV knowledge
Time frame: Baseline, 30 days, 60 days
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
Change in sexual risk behavior
Time frame: Baseline, 30 days, 60 days
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
Change in ethnic identity
Time frame: Baseline, 30 days, 60 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Derived from this study: PubMed 37556188Opara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ijeoma Opara, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theater/Pilot Testing in people with HIV/AIDS, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ijeoma Opara, PhD (908-494-3493, ijeoma.opara@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 30-day drug use (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05014074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.