Clinical trial NCT00891358: Empowerment Intervention for Young Women - Phase I
Official title: A Secondary Prevention Empowerment Intervention for Young Women Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Empowerment
HIV Infections
Keywords: Adolescent Medicine Trials Network for HIV/AIDS Interventions
Human Immunodeficiency Virus
HIV seronegativity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2009-05-01
Enrollment: 17
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Use of focus groups for development/adaptation of a secondary prevention empowerment intervention to reduce sexual risk behavior among young women living with HIV.
timeFrame: 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF College of Medicine
state: Florida
city: Chicago
country: United States
facility: Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical School
state: Maryland
Study officials:
affiliation: John Stroger Hospital of Cook County; Adolescent Trials Network
name: Sybil Hosek, PhD
role: STUDY_CHAIR
References: