Empowerment Intervention for Young Women - Phase I

NCT00891358 | Completed DMC

• 1 other identifier: ATN 073
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

This study will begin to develop a culturally appropriate secondary prevention intervention for young HIV+ women through focus groups. Using three intervention sites, focus groups will guide the development of the intervention's framework and content areas. An intervention will be developed/adapted through the data collected in the focus groups and review of relevant interventions. The intervention aims to address the following concerns: 1) reducing the risk of young women infected with HIV transmitting the virus to their sexual partners, and 2) preventing young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease.

Conditions

HIV; Empowerment; HIV Infections

Keywords

Adolescent Medicine Trials Network for HIV/AIDS Interventions; Human Immunodeficiency Virus; HIV seronegativity

Outcome Measures

Primary Outcomes (1)

• Use of focus groups for development/adaptation of a secondary prevention empowerment intervention to reduce sexual risk behavior among young women living with HIV.

  6-8 weeks

Study Arms (1)

Focus Group

EXPERIMENTAL

Participants in focus groups will meet and discuss their intervention needs.

Behavioral: Prevention Empowerment Intervention for Young Women

Interventions

Prevention Empowerment Intervention for Young Women BEHAVIORAL

Using three intervention sites, focus groups will guide the development of the intervention's framework and content areas. An initial list of content areas and potential activities for presentation to the focus groups will be developed by the protocol team by reviewing existing HIV prevention interventions that have been implemented with adolescents and young adults, as well as interventions that have targeted HIV+ populations. The three focus groups will be convened (1 per selected ATN site) with young women living with HIV to solicit information on their intervention needs.

Focus Group

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female at birth and currently female;
• Receives services at one of the selected ATN sites or their community partners;
• HIV-infected as documented by medical record review or verbal verification with referring professional;
• Between the ages of 16-24 (inclusive) at the time of informed consent/assent;
• Ability to understand both written and spoken English; and
• Gives informed consent/assent for study participation.

You may not qualify if:

• Presence of active, serious psychiatric symptoms (hallucinations, thought disorder) that would impair a participant's ability to meet the study requirements;
• Visibly distraught (suicidal, homicidal, exhibiting violent behavior);
• If other serious conditions are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment; or
• Intoxicated or under the influence of alcohol or other substances at the time of study enrollment\*.
• Participants cannot be visibly under the influence at the time of consent, enrollment, or during the focus group. Intoxication at the time of the focus group will exclude participation.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

USF College of Medicine

Tampa, Florida, 33606, United States

Location

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, 60612, United States

Location

University of Maryland Medical School

Baltimore, Maryland, 20723, United States

Location

Related Links

• ATN Website

MeSH Terms

Conditions

Empowerment; HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Sybil Hosek, PhD

  John Stroger Hospital of Cook County; Adolescent Trials Network

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: November 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: April 1, 2013
• Last Updated: March 6, 2017

Record last verified: 2016-07

Locations

US (3)