Development of an Empowerment Intervention for Young Women Living With HIV
| Tracking Information | |||||
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| First Received Date ICMJE | August 31, 2010 | ||||
| Last Updated Date | December 14, 2012 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on sexual risk and psychological empowerment [ Time Frame: 1 year ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01454921 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Development of an Empowerment Intervention for Young Women Living With HIV | ||||
| Official Title ICMJE | A Secondary Prevention Empowerment Intervention for Young Women Living With HIV | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | HIV | ||||
| Intervention ICMJE | 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). |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 43 | ||||
| Completion Date | October 2011 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 16 Years to 24 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01454921 | ||||
| Other Study ID Numbers ICMJE | ATN 089 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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