Development of an Empowerment Intervention for Young Women Living With HIV

HIV Clinical Trial

Official title:

A Secondary Prevention Empowerment Intervention for Young Women Living With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454921
• Other study ID #: ATN 089
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2010
• Last updated: February 27, 2017
• Start date: February 2010
• Est. completion date: October 2011

Study information

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

Clinical Trial Summary

This study will develop/adapt a culturally appropriate secondary prevention intervention for young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups, evaluate its acceptability and feasibility, make appropriate modifications, and manualize the intervention in preparation for a full-scale randomized trial.

Once the intervention is developed/adapted, the sites will pilot the interventions twice to enable modifications. 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 (STD). Data will be collected to assess the feasibility and acceptability of the newly developed intervention using both quantitative and qualitative methods at each iteration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• 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 years (inclusive) at the time of informed consent/assent

• Ability to understand both written and spoken English

• Gives informed consent/assent for study participation

Exclusion Criteria:

• Presence of active, serious psychiatric symptoms (e.g., hallucinations, thought disorder) that would impair a participant's ability to meet the study requirements

• Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior)

• Intoxicated or under the influence of alcohol or other substances at the time of study enrollment*.

• Intoxication at the time of visit will exclude participation at that time. Participants cannot be visibly under the influence of substances at the time of enrollment or consent. If a participant returns to enroll while sober, enrollment can occur. Similarly, if a participant arrives to an intervention group visibly intoxicated, then she will be asked to leave. However, prior intoxication does not eliminate future participation. Thus, those who are dismissed from a session due to intoxication can return to a subsequent session as long as they are sober.

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Evolution: Young Women Taking Charge and Growing Stronger
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 (STD).

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	Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on sexual risk and psychological empowerment	Compare pre-intervention ACASI scores on Sexual Activity and Sexual Risk and Psychological Empowerment Questionnaires with those collected immediately post-intervention and 3 months after intervention to determine effect of intervention on sexual risk and psychological empowerment.	1 year
Secondary	Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on self-efficacy, sexual negotiation, relational violence, forgiveness, anger, substance use, life goals and outcomes, and affect regulation	Compare pre-intervention ACASI scores on three self-efficacy scales, two sexual negotiation scales, the Rosenberg Self-Esteem Scale, the CTS2, the HFS, the TAS, the ASSIST, a life goals/outcomes scale, and the Affect Regulation Scale with those collected immediately post-intervention and 3 months after intervention to determine effect of intervention on sexual risk and psychological empowerment.	1 year

External Links

•   ATN Website