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Empowerment Intervention for Young Women - Phase I

Primary Purpose

HIV, Empowerment, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevention Empowerment Intervention for Young Women
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring Adolescent Medicine Trials Network for HIV/AIDS Interventions, Human Immunodeficiency Virus, HIV seronegativity

Eligibility Criteria

16 Years - 24 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • USF College of Medicine
  • Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
  • University of Maryland Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focus Group

Arm Description

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2009
Last Updated
March 2, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00891358
Brief Title
Empowerment Intervention for Young Women - Phase I
Official Title
A Secondary Prevention Empowerment Intervention for Young Women Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Empowerment, HIV Infections
Keywords
Adolescent Medicine Trials Network for HIV/AIDS Interventions, Human Immunodeficiency Virus, HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focus Group
Arm Type
Experimental
Arm Description
Participants in focus groups will meet and discuss their intervention needs.
Intervention Type
Behavioral
Intervention Name(s)
Prevention Empowerment Intervention for Young Women
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sybil Hosek, PhD
Organizational Affiliation
John Stroger Hospital of Cook County; Adolescent Trials Network
Official's Role
Study Chair
Facility Information:
Facility Name
USF College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Maryland Medical School
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
20723
Country
United States

12. IPD Sharing Statement

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Empowerment Intervention for Young Women - Phase I

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