Empowerment Intervention for Young Women - Phase I

HIV Infections Clinical Trial

Official title:

A Secondary Prevention Empowerment Intervention for Young Women Living With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891358
• Other study ID #: ATN 073
• Status: Completed
• Phase: N/A
• First received: April 30, 2009
• Last updated: March 2, 2017
• Start date: November 2008
• Est. completion date: April 2013

Study information

• Verified date: July 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2013
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Empowerment
• HIV
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland Medical School	Baltimore	Maryland
United States	Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital	Chicago	Illinois
United States	USF College of Medicine	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   ATN Website