HIV/STI Prevention Among Black Adolescents With Mental Illnesses (Project GOLD)

NCT03348813 | Completed

• 3 other identifiers: 814243U01PS003304P30MH097488
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Despite advances in HIV/sexually transmitted infection (STI) prevention, Black youth account for the largest number of new HIV infections among heterosexual youth. Having a mental illness contributes to HIV/STI risk among heterosexually active Black youth, as some use sex as a means to manage psychological distress, regulate emotions and receive validation or acceptance. Current intervention models focus on cognitive-behavioral strategies to reduce risk among adolescents; however, these approaches in isolation do not address the psychopathology that further potentiates risk behaviors among adolescents with mental illnesses. This randomized controlled trial evaluated the effects of "Project GOLD", a theoretically-driven, gender and culturally relevant, developmentally and psychologically appropriate HIV/STI risk reduction intervention on the sexual behaviors of Black male and female adolescents in Philadelphia (aged 14-17). In addition to evidence-based HIV/STI preventions strategies (e.g., role playing), Project GOLD includes unique emotion regulation content to address the relationship between psychological distress and HIV/STI risk behaviors. The research team approached and screened 704 adolescents. Eighty-two participated in the elicitation research activities (e.g., focus groups, intervention dress rehearsal). Another 173 underwent a structured demographic and mental health diagnostic interview to determine RCT eligibility. Project GOLD was then tested with 108 Black youth in comparison to a general health promotion control condition (intervention n = 52; control n = 56). Youth who were not in psychiatric treatment were also included, as the investigators hypothesized that they would also benefit from the targeted psychoeducational content; post-hoc analyses examined differences in the intervention effects based on whether or not youth were in psychiatric treatment. The intervention had high feasibility and acceptability. These findings underscore the need to encourage HIV/STI testing and risk reduction efforts among Black youth, including those with mental illnesses.

Conditions

HIV; STI; Emotional Disturbances; Mental Disorder

Keywords

Black; Adolescents; Community-based research; Randomized controlled trial; Intervention; Behavioral science

Outcome Measures

Primary Outcomes (1)

• Change from baseline consistent condom use at 12 months

  This dichotomous variable was defined by the comparison of the number of protected intercourse acts and the number of intercourse acts. Participants who report at least one intercourse act and whose number of reported protected acts equals their number of acts use condoms during 100% of intercourse acts and will be defined as practicing consistent condom use. Participants who report at least one intercourse act and whose reported number of protected acts is less than their number of acts will be coded as not practicing consistent condom use.

  12 months

Secondary Outcomes (3)

• Change from baseline number of sexual partners at 12 months

  12 months

• Change from baseline laboratory confirmed STIs at 12 months

  12 months

• Change from baseline HIV Diagnosis at 12 months

  12 months

Study Arms (2)

HIV/STI Prevention Intervention

EXPERIMENTAL

Two-session, small group HIV/STI prevention intervention.

Behavioral: HIV/STI Prevention Intervention

General Health Control Intervention

ACTIVE COMPARATOR

Two-session, small group general health promotion intervention.

Behavioral: General Health Control Intervention

Interventions

HIV/STI Prevention Intervention BEHAVIORAL

The targeted HIV/STI risk reduction intervention was delivered with groups of up to 8 participants through 8, 45-minute modules equally divided over 2 days (4 modules per session). It was designed to enhance participants' knowledge and ability to reduce their risk of HIV/STIs. Grounded in both social/behavioral and cognitive theories, the intervention includes psychoeducation, and was intended to enhance participants' HIV/STI prevention knowledge, attitudes, beliefs and skills in a manner relevant to Black adolescents.

HIV/STI Prevention Intervention

General Health Control Intervention BEHAVIORAL

The original Promoting Health among Teens (PHAT) Project was designed to increase knowledge and motivation regarding healthful dietary practices, aerobic exercise, and breast and testicular self-examination, and to discourage cigarette smoking. The 8-hour, 2-session PHAT intervention was shortened to mirror the Project GOLD HIV/STI risk reduction curriculum. This was done to control for the Hawthorne effect and reduce the likelihood that effects of the HIV/STI risk reduction intervention can be attributed to its nonspecific features, including special attention. From an ethical standpoint, adolescents in both conditions received a valuable and engaging health-risk-reduction intervention as opposed to "usual care."

General Health Control Intervention

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 17 years old
• Self-identify as Black (inclusive of African American, Caribbean-American, etc.)
• Have ever had vaginal sex
• Able to speak, read and write in the English language
• Able to provide signed informed consent/assent
• Plan to be in the Philadelphia area for the next 12 months.

You may not qualify if:

• Diagnosis of a psychotic disorder (i.e. Schizophrenia) or a disorder with psychotic features (ascertained by the MINI)
• Cognitive deficit that would impair ability to complete study procedures
• Actively suicidal (ascertained through the Columbia-Suicide Severity Rating Scale \[C-SSRS\]) or requiring hospitalization
• Unstable contact information (i.e. homeless or no permanent address, or no land line or mobile phone)
• Participants were not excluded for concurrent use of herbal remedies, mineral supplements, or psychopharmacologic therapies, however these factors will be controlled for in the data analyses.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Centers for Disease Control and Prevention: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Brawner BM, Jemmott LS, Wingood G, Reason J, Mack N. HIV/STI Prevention Among Heterosexually Active Black Adolescents With Mental Illnesses: Focus Group Findings for Intervention Development. J Assoc Nurses AIDS Care. 2018 Jan-Feb;29(1):30-44. doi: 10.1016/j.jana.2017.09.008. Epub 2017 Sep 28.

  PMID: 29037602 BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases; Affective Symptoms; Mental Disorders

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Bridgette M Brawner, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled participants were randomized to either the targeted intervention group or the attention control group at the diagnostic visit. The permuted-block randomization technique was used with a block size of 4 and a 1:1 allocation ratio. Dr. Alex Hanlon (biostatistics consultant) generated the randomization list using a pseudo-randomizer computer program. The Research Coordinator maintained the spreadsheet for tracking and allocation concealment. To reduce the risk of encountering a floor or ceiling effect with intervention responsiveness, participants were stratified based on their PHQ-9 total scores (none/moderate depression versus moderately severe/severe depression) and gender.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 21, 2017
• Study Start: August 1, 2014
• Primary Completion: December 22, 2016
• Study Completion: December 31, 2016
• Last Updated: November 29, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available starting 6 months after publication of the main study outcomes, and remain available.
• Access Criteria: Dr. Brawner will be responsible for making de-identified data collected from the study available to other investigators upon their request. Interested investigators will be able to request formal access to the data from Dr. Brawner in writing, and the request will be reviewed within a timely manner and data will be provided.

Locations

US (1)