Development of an Empowerment Intervention for Young Women Living With HIV

University of North Carolina (UNC)

Status and phase: Completed; Phase 2

Conditions: HIV

Treatments: Behavioral: Evolution: Young Women Taking Charge and Growing Stronger

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01454921

ATN 089

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Female

Ages: 16 to 24 years old

Volunteers: No 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 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Intervention I

Experimental group

Description:

Intervention group participants will be enrolled for the duration of one intervention program, which will last approximately 6 months. Each intervention program will consist of two individual and six group intervention sessions with each session lasting approximately 2-3 hours. Intervention participants will also complete two ACASI assessments (baseline and post-intervention) lasting approximately 1.5-2 hours each.

Treatment:

Behavioral: Evolution: Young Women Taking Charge and Growing Stronger

Intervention II

Experimental group

Description:

Intervention group participants will be enrolled for the duration of one intervention program, which will last approximately 6 months. Each intervention program will consist of two individual and six group intervention sessions with each session lasting approximately 2-3 hours. Intervention participants will also complete two ACASI assessments (baseline and post-intervention) lasting approximately 1.5-2 hours each.

Treatment:

Behavioral: Evolution: Young Women Taking Charge and Growing Stronger