Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention I | Experimental | 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. |
|
| Intervention II | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolution: Young Women Taking Charge and Growing Stronger | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
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*.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory Zimet, PhD | Adolescent Trials Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USF College of Medicine | Tampa | Florida | 33606 | United States | ||
| Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital |
Not provided
| Label | URL |
|---|---|
| ATN Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1 year |
| Chicago |
| Illinois |
| 60612 |
| United States |
| University of Maryland Medical School | Baltimore | Maryland | 20723 | United States |