Trial record 2 of 37 for:    " April 15, 2009":" May 15, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Empowerment Intervention for Young Women - Phase I

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00891358
First received: April 30, 2009
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
HIV
Empowerment
HIV Infections
Behavioral: Prevention Empowerment Intervention for Young Women
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Secondary Prevention Empowerment Intervention for Young Women Living With HIV

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Use of focus groups for development/adaptation of a secondary prevention empowerment intervention to reduce sexual risk behavior among young women living with HIV. [ Time Frame: 6-8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Focus Group
Participants in focus groups will meet and discuss their intervention needs.
Behavioral: Prevention Empowerment Intervention for Young Women

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.


Detailed Description:

This study will develop/adapt 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 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.

Three focus groups will be convened (1 per selected ATN site) with young women living with HIV to solicit information on their intervention needs. All focus groups will be digitally recorded and transcribed. Executive summaries of the groups will focus on the major themes elicited by probes that explore the proposed content and structure of the interventions. The summaries will be generated by members of the Protocol Team and based on a review and integration of data from a) focus group flip charts; b) digitally recorded comments from participants; c) digitally recorded oral summaries by moderators offered during the focus groups; and d) thematic notes taken by the assistant moderator during the focus groups. Based on the outcome of the focus groups, intervention modules will be developed and modified in collaboration with the Youth Advisory Team.

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891358

Locations
United States, Florida
USF College of Medicine
Tampa, Florida, United States, 33606
United States, Illinois
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland Medical School
Baltimore, Maryland, United States, 20723
Sponsors and Collaborators
Investigators
Study Chair: Sybil Hosek, PhD John Stroger Hospital of Cook County; Adolescent Trials Network
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00891358     History of Changes
Other Study ID Numbers: ATN 073
Study First Received: April 30, 2009
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Adolescent Medicine Trials Network for HIV/AIDS Interventions
Human Immunodeficiency Virus
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 19, 2014