Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women

This study has been completed.
Sponsor:
Collaborator:
SisterLove, Inc.
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00362375
First received: August 8, 2006
Last updated: April 27, 2010
Last verified: April 2010
Results First Received: March 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HIV Infections
Sexually Transmitted Infections
Interventions: Behavioral: Healthy Love Workshop
Behavioral: HIV/AIDS 101 Workshop

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Healthy Love Workshop The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
HIV101 The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
Total Total of all reporting groups

Baseline Measures
    Healthy Love Workshop     HIV101     Total  
Number of Participants  
[units: participants]
  161     152     313  
Age  
[units: years]
Mean ± Standard Deviation
  29.1  ± 10.1     33.7  ± 12.7     31.3  ± 11.6  
Gender  
[units: participants]
     
Female     161     152     313  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     161     152     313  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Condom Use During Vaginal Sex With Any Male Partner   [ Time Frame: Past 3 months ]

2.  Secondary:   HIV Testing and Receipt of Results   [ Time Frame: Past 3 months ]

3.  Other Pre-specified:   Sexual Abstinence   [ Time Frame: Past 3 months ]

4.  Other Pre-specified:   Unprotected Vaginal Sex With Any Male Partner   [ Time Frame: Past 3 months ]

5.  Other Pre-specified:   Number of Male Sex Partners   [ Time Frame: Past 3 months ]

6.  Secondary:   HIV Knowledge   [ Time Frame: current ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Condom Use Self-efficacy   [ Time Frame: current ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Knowledge of HIV Test   [ Time Frame: current ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dazon Dixon-Diallo, Executive Director
Organization: SisterLove, Inc.
phone: 404-505-7777
e-mail: ddiallo@sisterlove.org


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Dazon Dixon Diallo, MPH, CEO, SisterLove, Inc.
ClinicalTrials.gov Identifier: NCT00362375     History of Changes
Other Study ID Numbers: CDC-NCHSTP-1927-4768, U65/CCU424514-02
Study First Received: August 8, 2006
Results First Received: March 8, 2010
Last Updated: April 27, 2010
Health Authority: United States: Federal Government